Breast Cancer
Conditions
Keywords
whole breast radiotherapy, tumor bed boost
Brief summary
All patients (with Stages 0-II breast cancer) will receive an accelerated three week regimen of prone whole breast radiotherapy. The study intends to test the hypothesis that a weekly boost to the tumor bed, delivered on Friday, before the weekend break, is as well tolerated as the daily boost during accelerated prone radiotherapy.
Detailed description
Arm 1 is a concomitant boost protocol over three weeks which has previously been evaluated in over 500 patients (NYU 03-30 and NYU 05-181) and has shown excellent tolerance, and results. Arm 2 evaluates a Weekend Boost Dose (WBD) regimen which may have a radiobiological advantage by counteracting tumor repopulation which can occur over the weekend break. At the time of registration in the study, patients will be randomized to either treatment arm and stratified according to pre or post-menopausal status and on previous chemotherapy received or not.
Interventions
RADIATIONDaily Radiation Therapy
15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
RADIATIONWeekly Radiation Therapy
15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pre or post-menopausal women with stage 0,I, and II breast cancer * Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm * Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors \<5mm do not require nodal assessment) * At least 2 weeks from last chemotherapy * Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document
Exclusion criteria
* Previous radiation therapy to the ipsilateral breast * More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation * Active connective tissue disorders, such as lupus or scleroderma * Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free \>3 years * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG) | Day 60 | Number of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score on SF-36 v2 Vitality Scale | Baseline | SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or vitality, at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = All of the time; 2 = Most of the time; 3 = Some of the time; 4 = A little of the time; 5 = None of the time. |
| Average Score on Brief Pain Inventory (BPI) Scale | Baseline | The BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level. |
| Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale | Baseline | 4 levels: 1 = Excellent; 2 = Good; 3 = Fair; 4 = Poor. The total range is 1-4; the higher the score, the lower the breast quality. |
| Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment | At the end of Treatment, an average of 3 weeks | BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = No difference; 2 = Slight; 3 = Moderate; 4 = Large difference. The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast. |
| Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline | Baseline | BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = No difference; 2 = Slight; 3 = Moderate; 4 = Large difference. The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast. |
| Score on SF-36 v2 Vitality Scale 45-60 Days After Treatment | 45-60 days after treatment | SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or vitality, at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = All of the time; 2 = Most of the time; 3 = Some of the time; 4 = A little of the time; 5 = None of the time. |
| Average Score on Brief Pain Inventory (BPI) | At the end of Treatment, an average of 3 weeks | The BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level. |
| Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment | End of Treatment | 4 levels: 1 = Excellent; 2 = Good; 3 = Fair; 4 = Poor |
| Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment | 45-60 days after treatment | 4 levels: 1 = Excellent; 2 = Good; 3 = Fair; 4 = Poor. |
| Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) | 45-60 days after treatment | BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = No difference; 2 = Slight; 3 = Moderate; 4 = Large difference. The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ARM 1 Daily Boost Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed. | 206 |
| ARM 2 Weekly Boost Radiation Therapy
Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed. | 206 |
| Total | 412 |
Baseline characteristics
| Characteristic | ARM 1 Daily Boost | ARM 2 Weekly Boost | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 51 Participants | 38 Participants | 89 Participants |
| Age, Categorical Between 18 and 65 years | 155 Participants | 168 Participants | 323 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 17 Participants | 36 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 26 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 13 Participants | 19 Participants |
| Race (NIH/OMB) White | 158 Participants | 150 Participants | 308 Participants |
| Region of Enrollment United States | 206 participants | 206 participants | 412 participants |
| Sex: Female, Male Female | 206 Participants | 206 Participants | 412 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 89 / 202 | 72 / 198 |
| serious Total, serious adverse events | 0 / 202 | 0 / 198 |
Outcome results
Primary
Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)
Number of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects
Time frame: Day 60
Population: Patients receiving either daily or weekly boost to radiation therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ARM 1 Daily Boost | Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG) | 22 participants |
| ARM 2 Weekly Boost | Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG) | 16 participants |
Secondary
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS)
BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = No difference; 2 = Slight; 3 = Moderate; 4 = Large difference. The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.
Time frame: 45-60 days after treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARM 1 Daily Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) | Functional Status | 6.93 score on a scale | Standard Deviation 3.13 |
| ARM 1 Daily Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) | Cosmetic Status | 10.17 score on a scale | Standard Deviation 3.07 |
| ARM 1 Daily Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) | Breast Specific Pain | 3.94 score on a scale | Standard Deviation 1.34 |
| ARM 2 Weekly Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) | Functional Status | 7.01 score on a scale | Standard Deviation 2.79 |
| ARM 2 Weekly Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) | Cosmetic Status | 10.00 score on a scale | Standard Deviation 2.84 |
| ARM 2 Weekly Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) | Breast Specific Pain | 3.80 score on a scale | Standard Deviation 1.4 |
Secondary
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline
BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = No difference; 2 = Slight; 3 = Moderate; 4 = Large difference. The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARM 1 Daily Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline | Functional Status | 6.89 score on a scale | Standard Deviation 2.72 |
| ARM 1 Daily Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline | Cosmetic Status | 9.71 score on a scale | Standard Deviation 3.2 |
| ARM 1 Daily Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline | Breast Specific Pain | 3.69 score on a scale | Standard Deviation 1.28 |
| ARM 2 Weekly Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline | Functional Status | 7.03 score on a scale | Standard Deviation 2.74 |
| ARM 2 Weekly Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline | Cosmetic Status | 9.9 score on a scale | Standard Deviation 3.32 |
| ARM 2 Weekly Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline | Breast Specific Pain | 3.87 score on a scale | Standard Deviation 1.47 |
Secondary
Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment
BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories. There are 4 score levels: 1 = No difference; 2 = Slight; 3 = Moderate; 4 = Large difference. The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.
Time frame: At the end of Treatment, an average of 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARM 1 Daily Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment | Functional Status | 7.08 score on a scale | Standard Deviation 2.72 |
| ARM 1 Daily Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment | Cosmetic Status | 10.29 score on a scale | Standard Deviation 3.17 |
| ARM 1 Daily Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment | Breast Specific Pain | 4.57 score on a scale | Standard Deviation 1.34 |
| ARM 2 Weekly Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment | Functional Status | 7.56 score on a scale | Standard Deviation 3.24 |
| ARM 2 Weekly Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment | Cosmetic Status | 10.10 score on a scale | Standard Deviation 3.11 |
| ARM 2 Weekly Boost | Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment | Breast Specific Pain | 4.51 score on a scale | Standard Deviation 1.51 |
Secondary
Average Score on Brief Pain Inventory (BPI)
The BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.
Time frame: At the end of Treatment, an average of 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARM 1 Daily Boost | Average Score on Brief Pain Inventory (BPI) | 1.46 score on a scale | Standard Deviation 1.59 |
| ARM 2 Weekly Boost | Average Score on Brief Pain Inventory (BPI) | 1.66 score on a scale | Standard Deviation 1.67 |
Secondary
Average Score on Brief Pain Inventory (BPI)
The BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.
Time frame: 45-60 days after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARM 1 Daily Boost | Average Score on Brief Pain Inventory (BPI) | 1.23 score on a scale | Standard Deviation 1.51 |
| ARM 2 Weekly Boost | Average Score on Brief Pain Inventory (BPI) | 1.37 score on a scale | Standard Deviation 1.52 |
Secondary
Average Score on Brief Pain Inventory (BPI) Scale
The BPI is a self-administered assessment tool used in pain management. The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain The total range is 1-10; the higher the score, the higher the pain level.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ARM 1 Daily Boost | Average Score on Brief Pain Inventory (BPI) Scale | 1.46 score on a scale | Standard Deviation 1.59 |
| ARM 2 Weekly Boost | Average Score on Brief Pain Inventory (BPI) Scale | 1.71 score on a scale | Standard Deviation 1.65 |
Secondary
Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale
4 levels: 1 = Excellent; 2 = Good; 3 = Fair; 4 = Poor. The total range is 1-4; the higher the score, the lower the breast quality.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARM 1 Daily Boost | Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale | Convenience of Care | 2.53 score on a scale | Standard Deviation 2.38 |
| ARM 1 Daily Boost | Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale | Satisfaction on Breast Looks | 1.97 score on a scale | Standard Deviation 0.78 |
| ARM 1 Daily Boost | Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale | Satisfaction about Treatment | 1.47 score on a scale | Standard Deviation 0.78 |
| ARM 2 Weekly Boost | Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale | Satisfaction on Breast Looks | 1.96 score on a scale | Standard Deviation 0.84 |
| ARM 2 Weekly Boost | Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale | Satisfaction about Treatment | 1.41 score on a scale | Standard Deviation 0.71 |
| ARM 2 Weekly Boost | Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale | Convenience of Care | 2.84 score on a scale | Standard Deviation 2.41 |
Secondary
Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment
4 levels: 1 = Excellent; 2 = Good; 3 = Fair; 4 = Poor.
Time frame: 45-60 days after treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARM 1 Daily Boost | Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment | Breast Looks now | 2.02 score on a scale | Standard Deviation 0.73 |
| ARM 1 Daily Boost | Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment | Satisfaction about Treatment | 1.33 score on a scale | Standard Deviation 0.72 |
| ARM 2 Weekly Boost | Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment | Breast Looks now | 1.94 score on a scale | Standard Deviation 0.76 |
| ARM 2 Weekly Boost | Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment | Satisfaction about Treatment | 1.32 score on a scale | Standard Deviation 0.67 |
Secondary
Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment
4 levels: 1 = Excellent; 2 = Good; 3 = Fair; 4 = Poor
Time frame: End of Treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARM 1 Daily Boost | Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment | Breast Looks now | 2.12 score on a scale | Standard Deviation 0.74 |
| ARM 1 Daily Boost | Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment | Satisfaction about Treatment | 1.35 score on a scale | Standard Deviation 0.68 |
| ARM 2 Weekly Boost | Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment | Breast Looks now | 1.95 score on a scale | Standard Deviation 0.82 |
| ARM 2 Weekly Boost | Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment | Satisfaction about Treatment | 1.33 score on a scale | Standard Deviation 0.65 |
Secondary
Score on SF-36 v2 Vitality Scale
SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or vitality, at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = All of the time; 2 = Most of the time; 3 = Some of the time; 4 = A little of the time; 5 = None of the time.
Time frame: End of Treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARM 1 Daily Boost | Score on SF-36 v2 Vitality Scale | Good Feeling | 2.55 score on a scale | Standard Deviation 0.87 |
| ARM 1 Daily Boost | Score on SF-36 v2 Vitality Scale | Bad Feeling | 3.32 score on a scale | Standard Deviation 0.86 |
| ARM 2 Weekly Boost | Score on SF-36 v2 Vitality Scale | Good Feeling | 3.59 score on a scale | Standard Deviation 0.92 |
| ARM 2 Weekly Boost | Score on SF-36 v2 Vitality Scale | Bad Feeling | 3.25 score on a scale | Standard Deviation 0.99 |
Secondary
Score on SF-36 v2 Vitality Scale
SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or vitality, at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = All of the time; 2 = Most of the time; 3 = Some of the time; 4 = A little of the time; 5 = None of the time.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARM 1 Daily Boost | Score on SF-36 v2 Vitality Scale | Good Feeling | 2.56 score on a scale | Standard Deviation 0.91 |
| ARM 1 Daily Boost | Score on SF-36 v2 Vitality Scale | Bad Feeling | 3.3 score on a scale | Standard Deviation 0.88 |
| ARM 2 Weekly Boost | Score on SF-36 v2 Vitality Scale | Good Feeling | 2.65 score on a scale | Standard Deviation 0.95 |
| ARM 2 Weekly Boost | Score on SF-36 v2 Vitality Scale | Bad Feeling | 3.3 score on a scale | Standard Deviation 0.97 |
Secondary
Score on SF-36 v2 Vitality Scale 45-60 Days After Treatment
SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or vitality, at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = All of the time; 2 = Most of the time; 3 = Some of the time; 4 = A little of the time; 5 = None of the time.
Time frame: 45-60 days after treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARM 1 Daily Boost | Score on SF-36 v2 Vitality Scale 45-60 Days After Treatment | Good Feeling | 2.46 score on a scale | Standard Deviation 0.78 |
| ARM 1 Daily Boost | Score on SF-36 v2 Vitality Scale 45-60 Days After Treatment | Bad Feeling | 3.29 score on a scale | Standard Deviation 0.92 |
| ARM 2 Weekly Boost | Score on SF-36 v2 Vitality Scale 45-60 Days After Treatment | Good Feeling | 2.36 score on a scale | Standard Deviation 0.91 |
| ARM 2 Weekly Boost | Score on SF-36 v2 Vitality Scale 45-60 Days After Treatment | Bad Feeling | 3.45 score on a scale | Standard Deviation 0.84 |