Hodgkin Lymphoma
Conditions
Keywords
Lymphoma, Hodgkin Disease
Brief summary
With the success of current chemotherapy for Hodgkin's disease, the goal of this protocol is to maintain the currently successful cure rate and reduce treatment related side effects and long term toxicity. The main purpose of this study is to estimate the event free survival of patients treated with risk-adapted therapy compared to historical controls.
Detailed description
This study will evaluate the following objectives: Primary Objectives: 1. To evaluate the efficacy of 4 cycles of VAMP chemotherapy alone in patients with favorable risk Hodgkin's disease who achieve a complete response after 2 cycles of VAMP chemotherapy. 2. To evaluate the efficacy of 4 cycles VAMP chemotherapy plus low dose RT in patients with favorable risk Hodgkin's disease who achieve a partial response after 2 cycles of VAMP chemotherapy. 3. To evaluate the efficacy of 2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT in children with intermediate risk Hodgkin's disease. 4. To evaluate the efficacy of 12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children with unfavorable risk Hodgkin's disease. Secondary Objectives: 1. To evaluate patient quality of life during and after treatment from the patient and parent perspective. 2. To compare patient and parental ratings of treatment-related symptoms and patient physical, psychological, social and cognitive functioning before the first treatment (T1 - baseline); after Cycle 2 or after 8 weeks of Stanford V (T2 - Evaluate Response); after cycle 4 or after 12 weeks of Stanford V and before or on the first day of radiation (as applicable) (T3); at the conclusion of radiation or within a few days following the end of radiation (as applicable) (T4); and at 3 to 6 months after completion of therapy follow-up evaluation (T5).
Interventions
DRUG12 Week Stanford V Chemotherapy
12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children
DRUG4 cycles of VAMP chemotherapy
4 cycles of VAMP chemotherapy alone in patients who achieve a complete response after 2 cycles of VAMP chemotherapy. For patients that do not achieve a complete response after 2 cycles of VAMP, they will receive low low-dose involved field radiotherapy at the end of all chemotherapy.
DRUG2 alternating cycles of VAMP/COP chemotherapy
2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT.
DRUG3 alternating cycles of VAMP/COP chemotherapy
3 alternating cycles of VAMP/COP chemotherapy (total 6 cycles of chemotherapy) plus low-dose, involved-field RT
Sponsors
St. Jude Children's Research Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* Eligible patients must have histologically confirmed previously untreated Hodgkin's disease (Patients receiving limited emergent RT or steroid therapy because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment). * Patients must be 21 years of age or younger * Ann Arbor stages IIB-IV * No prior treatment. * No pregnant or lactating women. * Signed informed consent * If re-evaluation of a patient's disease shows favorable risk features or intermediate risk features, the patient will be removed from the HOD99 study and consented to the respective HOD08 or HOD05 study. Inclusion: treatment of favorable risk features: * Ann Arbor IA or IIA with: 1. Non-bulky mediastinal disease (\<33% mediastinal to thoracic ratio on chest x ray) 2. Ann Arbor stage IA or IIA with any of the following features: (1) E lesions (s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph) Inclusion: unfavorable risk features: * Stage must be classified as one of the following: 1. Ann Arbor stage IIB, IIIB, or any IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free Survival Probability by Risk Group | Median 6.4 year follow-up | Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the Greenwood's formula. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy physical quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy emotional quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy social quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy school quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy psychosocial quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points. | At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy Peds QL4 (composite) quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). | Assess and compare the patient reported and parent proxy pain and hurt quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) | Assess and compare the patient reported and parent proxy procedural anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) | Assess and compare the patient reported and parent proxy treatment anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) | Assess and compare the patient reported and parent proxy worry quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) | Assess and compare the patient reported and parent proxy cognitive problems (child + teen) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) | Assess and compare the patient reported and parent proxy perceived physical appearance quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) | Assess and compare the patient reported and parent proxy communication quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) | Assess and compare the patient reported and parent proxy PedsQL3 (composite) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
| Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points. | At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) | Assess and compare the patient reported and parent proxy nausea quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Event-free Survival Probability by Risk Group at 10-year Follow-Up | 10-year follow-up after protocol enrollment | Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the with Greenwood's formula. |
Countries
United States
Participant flow
Recruitment details
296 patients were enrolled from 5 institutions between March 2000 and May 2011.
Participants by arm
| Arm | Count |
|---|---|
| Favorable Risk Ann Arbor stage IA or IIA with:
1. Non-bulky mediastinal disease (\<33% mediastinal to thoracic ratio on chest x-ray)
2. \< 3 nodal regions involved on the same side of the diaphragm
3. No extranodal extension of disease | 91 |
| Intermediate Risk Stage must be classified as one of the following:
1. Ann Arbor stage IB and IIIA
2. Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph) | 46 |
| Unfavorable Risk, Group 1 Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13). | 13 |
| Unfavorable Risk, Group 2 Stage must be classified as one of the following:
a. Ann Arbor stage IIB, IIIB, or any IV | 146 |
| Total | 296 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 2 | 2 | 6 |
| Overall Study | Ineligible | 3 | 0 | 1 | 5 |
| Overall Study | Lost to Follow-up | 2 | 6 | 2 | 4 |
| Overall Study | Noncompliance | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Favorable Risk | Intermediate Risk | Unfavorable Risk, Group 1 | Unfavorable Risk, Group 2 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 84 Participants | 36 Participants | 11 Participants | 122 Participants | 253 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 10 Participants | 2 Participants | 24 Participants | 43 Participants |
| Age, Continuous | 13.08 years STANDARD_DEVIATION 3.91 | 15.35 years STANDARD_DEVIATION 3.28 | 14.85 years STANDARD_DEVIATION 3.21 | 15.06 years STANDARD_DEVIATION 3.37 | 14.48 years STANDARD_DEVIATION 3.63 |
| Sex: Female, Male Female | 32 Participants | 26 Participants | 5 Participants | 80 Participants | 143 Participants |
| Sex: Female, Male Male | 59 Participants | 20 Participants | 8 Participants | 66 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 54 / 88 | 39 / 46 | 12 / 13 | 116 / 146 |
| serious Total, serious adverse events | 0 / 91 | 0 / 46 | 0 / 13 | 1 / 146 |
Outcome results
Primary
Event-free Survival Probability by Risk Group
Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the Greenwood's formula.
Time frame: Median 6.4 year follow-up
Population: Nine patients were ineligible for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Favorable Risk | Event-free Survival Probability by Risk Group | 0.886 probability of 5 yr. event free survival |
| Intermediate Risk | Event-free Survival Probability by Risk Group | 0.844 probability of 5 yr. event free survival |
| Unfavorable Risk, Group 1 | Event-free Survival Probability by Risk Group | 0.667 probability of 5 yr. event free survival |
| Unfavorable Risk, Group 2 | Event-free Survival Probability by Risk Group | 0.793 probability of 5 yr. event free survival |
95% CI: [0.82, 0.953]
95% CI: [0.739, 0.95]
95% CI: [0.4, 0.933]
95% CI: [0.726, 0.86]
Secondary
Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy cognitive problems (child + teen) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Population: Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points. | 77.6 units on a scale | Standard Deviation 19.2 |
| Intermediate Risk | Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points. | 75.7 units on a scale | Standard Deviation 19.7 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points. | 78.9 units on a scale | Standard Deviation 20.2 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points. | 74.3 units on a scale | Standard Deviation 22.2 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points. | 80.8 units on a scale | Standard Deviation 20.4 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points. | 76.3 units on a scale | Standard Deviation 22.6 |
p-value: 0.4807Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.0824Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.0496Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy communication quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Population: Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points. | 78.3 units on a scale | Standard Deviation 19.5 |
| Intermediate Risk | Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points. | 73.6 units on a scale | Standard Deviation 27.8 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points. | 80.6 units on a scale | Standard Deviation 19.9 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points. | 74.9 units on a scale | Standard Deviation 25.2 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points. | 83.7 units on a scale | Standard Deviation 19.5 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points. | 83.1 units on a scale | Standard Deviation 20.6 |
p-value: 0.0831Wilcoxon signed rank test
p-value: 0.0027Spearman Correlation Coefficients
p-value: 0.0135Wilcoxon signed rank test
p-value: 0.0024Spearman Correlation Coefficients
p-value: 0.9848Wilcoxon signed rank test
p-value: 0.0974Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy emotional quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Population: Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points. | 68.4 units on a scale | Standard Deviation 18.1 |
| Intermediate Risk | Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points. | 62.3 units on a scale | Standard Deviation 20.1 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points. | 70.7 units on a scale | Standard Deviation 20.5 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points. | 64 units on a scale | Standard Deviation 18.3 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points. | 74.1 units on a scale | Standard Deviation 20.4 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points. | 65.7 units on a scale | Standard Deviation 20.2 |
| Patient 3-6 Months After the Completion of Therapy (T5) | Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points. | 78.5 units on a scale | Standard Deviation 21.3 |
| Parent 3-6 Months After the Completion of Therapy (T5) | Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points. | 77.1 units on a scale | Standard Deviation 19.5 |
p-value: <0.0001Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.0001Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: <0.0001Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.3624Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy nausea quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Population: Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points. | 60.7 units on a scale | Standard Deviation 22.5 |
| Intermediate Risk | Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points. | 58.6 units on a scale | Standard Deviation 22 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points. | 59.7 units on a scale | Standard Deviation 24.9 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points. | 57.7 units on a scale | Standard Deviation 23.8 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points. | 75 units on a scale | Standard Deviation 22.6 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points. | 78.9 units on a scale | Standard Deviation 22.9 |
p-value: 0.2758Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.1731Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.0846Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy pain and hurt quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Population: Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points. | 67.7 units on a scale | Standard Deviation 25.2 |
| Intermediate Risk | Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points. | 57.3 units on a scale | Standard Deviation 24.6 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points. | 69.4 units on a scale | Standard Deviation 26.4 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points. | 60.2 units on a scale | Standard Deviation 25.7 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points. | 83.4 units on a scale | Standard Deviation 23.4 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points. | 77 units on a scale | Standard Deviation 23.7 |
p-value: <0.0001Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: <0.0001Wilcoxan signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.0017Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy PedsQL3 (composite) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Population: Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points. | 72.4 units on a scale | Standard Deviation 14.6 |
| Intermediate Risk | Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points. | 68.3 units on a scale | Standard Deviation 14.7 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points. | 72.7 units on a scale | Standard Deviation 16.7 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points. | 67.6 units on a scale | Standard Deviation 16.3 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points. | 78.1 units on a scale | Standard Deviation 16 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points. | 77.6 units on a scale | Standard Deviation 16 |
p-value: 0.004Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.0012Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.8108Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy Peds QL4 (composite) quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Population: Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points. | 76.2 units on a scale | Standard Deviation 14.9 |
| Intermediate Risk | Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points. | 72.4 units on a scale | Standard Deviation 17.7 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points. | 74.2 units on a scale | Standard Deviation 15.4 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points. | 69.3 units on a scale | Standard Deviation 16.2 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points. | 77 units on a scale | Standard Deviation 15.1 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points. | 70.6 units on a scale | Standard Deviation 16.1 |
| Patient 3-6 Months After the Completion of Therapy (T5) | Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points. | 84 units on a scale | Standard Deviation 13.7 |
| Parent 3-6 Months After the Completion of Therapy (T5) | Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points. | 80.7 units on a scale | Standard Deviation 16.2 |
p-value: 0.0281Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.005Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.0005Wilcoxon signed rank test
p-value: 0.0001Spearman Correlation Coefficients
p-value: 0.0552Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy perceived physical appearance quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Population: Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points. | 77.5 units on a scale | Standard Deviation 23.1 |
| Intermediate Risk | Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points. | 71.9 units on a scale | Standard Deviation 25.9 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points. | 77.6 units on a scale | Standard Deviation 23.3 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points. | 71.2 units on a scale | Standard Deviation 26.6 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points. | 78.4 units on a scale | Standard Deviation 25 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points. | 80.5 units on a scale | Standard Deviation 22.8 |
p-value: 0.0157Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.0014Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.1478Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy physical quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Population: Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | 77.2 units on a scale | Standard Deviation 21.4 |
| Intermediate Risk | Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | 73.9 units on a scale | Standard Deviation 24.5 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | 72.3 units on a scale | Standard Deviation 20.2 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | 65.4 units on a scale | Standard Deviation 21.9 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | 74.7 units on a scale | Standard Deviation 20.9 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | 66.5 units on a scale | Standard Deviation 21 |
| Patient 3-6 Months After the Completion of Therapy (T5) | Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | 84.5 units on a scale | Standard Deviation 16.6 |
| Parent 3-6 Months After the Completion of Therapy (T5) | Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points. | 78.6 units on a scale | Standard Deviation 22.7 |
p-value: 0.0197Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.3097Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: <0.0001Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: <0.0001Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy procedural anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Population: Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points. | 71.3 units on a scale | Standard Deviation 27.9 |
| Intermediate Risk | Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points. | 70.3 units on a scale | Standard Deviation 27.9 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points. | 73.8 units on a scale | Standard Deviation 27.7 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points. | 63.2 units on a scale | Standard Deviation 29.6 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points. | 78.5 units on a scale | Standard Deviation 25.4 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points. | 72.7 units on a scale | Standard Deviation 28.1 |
p-value: 0.4263Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: <0.0001Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.0468Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy psychosocial quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Population: Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points. | 75.7 units on a scale | Standard Deviation 13.5 |
| Intermediate Risk | Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points. | 71.3 units on a scale | Standard Deviation 16.4 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points. | 75.1 units on a scale | Standard Deviation 15 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points. | 71.1 units on a scale | Standard Deviation 15.3 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points. | 77.5 units on a scale | Standard Deviation 15.1 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points. | 72.3 units on a scale | Standard Deviation 15.9 |
| Patient 3-6 Months After the Completion of Therapy (T5) | Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points. | 83.1 units on a scale | Standard Deviation 14.7 |
| Parent 3-6 Months After the Completion of Therapy (T5) | Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points. | 80.7 units on a scale | Standard Deviation 15.9 |
p-value: 0.0014Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.0282Wilcoxon signed rank test
p-value: 0.0002Spearman Correlation Coefficients
p-value: 0.0038Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.1474Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy school quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Population: Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points. | 69.6 units on a scale | Standard Deviation 18 |
| Intermediate Risk | Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points. | 66.2 units on a scale | Standard Deviation 22.1 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points. | 67.2 units on a scale | Standard Deviation 20.6 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points. | 66.7 units on a scale | Standard Deviation 21.8 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points. | 69 units on a scale | Standard Deviation 21.6 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points. | 66.7 units on a scale | Standard Deviation 21.6 |
| Patient 3-6 Months After the Completion of Therapy (T5) | Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points. | 78.6 units on a scale | Standard Deviation 18.3 |
| Parent 3-6 Months After the Completion of Therapy (T5) | Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points. | 76.5 units on a scale | Standard Deviation 20 |
p-value: 0.0687Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficient
p-value: 0.9478Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.2999Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.3121Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy social quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).
Population: Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points. | 87.2 units on a scale | Standard Deviation 16 |
| Intermediate Risk | Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points. | 83 units on a scale | Standard Deviation 20.2 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points. | 87.2 units on a scale | Standard Deviation 14.5 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points. | 81.4 units on a scale | Standard Deviation 17.8 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points. | 88.2 units on a scale | Standard Deviation 12.9 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points. | 82.2 units on a scale | Standard Deviation 16.2 |
| Patient 3-6 Months After the Completion of Therapy (T5) | Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points. | 91.5 units on a scale | Standard Deviation 13.2 |
| Parent 3-6 Months After the Completion of Therapy (T5) | Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points. | 85.8 units on a scale | Standard Deviation 17.4 |
p-value: 0.0254Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.0004Wilcoxon signed rank test
p-value: 0.0001Spearman Correlation Coefficients
p-value: <0.0001Wilcoxon Correlation Coefficients
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.0014Wilcoxon signed rank test
p-value: 0.0061Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy treatment anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Population: Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points. | 84.1 units on a scale | Standard Deviation 20.6 |
| Intermediate Risk | Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points. | 72.8 units on a scale | Standard Deviation 25.2 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points. | 82.8 units on a scale | Standard Deviation 22.7 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points. | 71.1 units on a scale | Standard Deviation 24.9 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points. | 82.1 units on a scale | Standard Deviation 23 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points. | 77.6 units on a scale | Standard Deviation 24.2 |
p-value: <0.0001Wilcoxon signed rank test
p-value: 0.0019Spearman Correlation Coefficients
p-value: <0.0001Wilcoxon signed rank test
p-value: 0.0704Spearman Correlation Coefficients
p-value: 0.02Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
Secondary
Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points.
Assess and compare the patient reported and parent proxy worry quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.
Time frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)
Population: Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Favorable Risk | Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points. | 64.5 units on a scale | Standard Deviation 24.2 |
| Intermediate Risk | Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points. | 64.5 units on a scale | Standard Deviation 21.3 |
| Unfavorable Risk, Group 1 | Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points. | 64.7 units on a scale | Standard Deviation 24.9 |
| Unfavorable Risk, Group 2 | Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points. | 64.7 units on a scale | Standard Deviation 23.6 |
| Patient Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points. | 67.1 units on a scale | Standard Deviation 28 |
| Parent Completion of 4 Cycles of Chemotherapy (T3) | Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points. | 68.6 units on a scale | Standard Deviation 25.9 |
p-value: 0.7626Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.7192Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
p-value: 0.8663Wilcoxon signed rank test
p-value: <0.0001Spearman Correlation Coefficients
Other Pre-specified
Event-free Survival Probability by Risk Group at 10-year Follow-Up
Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the with Greenwood's formula.
Time frame: 10-year follow-up after protocol enrollment
Population: Nine patients were ineligible for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Favorable Risk | Event-free Survival Probability by Risk Group at 10-year Follow-Up | 0.874 probability 10 yr. event free survival |
| Intermediate Risk | Event-free Survival Probability by Risk Group at 10-year Follow-Up | 0.844 probability 10 yr. event free survival |
| Unfavorable Risk, Group 1 | Event-free Survival Probability by Risk Group at 10-year Follow-Up | 0.667 probability 10 yr. event free survival |
| Unfavorable Risk, Group 2 | Event-free Survival Probability by Risk Group at 10-year Follow-Up | 0.785 probability 10 yr. event free survival |
95% CI: [0.805, 0.944]
95% CI: [0.739, 0.95]
95% CI: [0.4, 0.933]
95% CI: [0.716, 0.853]