Acute Myeloid Leukemia
Conditions
Keywords
Symptoms, Function, Quality of life, Acute myeloid leukemia, Palliative care, Supportive care
Brief summary
This single institution feasibility and acceptability study includes patients with acute leukemia which is designed to examine a novel palliative and supportive care intervention (Palliative and supportive Care inTervention; PACT) in which registered nurses (RNs), occupational therapists (OTs), and physical therapists (PTs) address the activity needs of older adults with acute leukemia during their hospital stay.
Detailed description
The primary objective of the study is to assess feasibility, acceptability, and change in pre and post measures of symptoms, function, and QOL by administering the PACT intervention. The first 20 participants in the control group will receive usual care. The next 20 participants will receive the PACT intervention. Each participant in the intervention group will be cared by a collaborative, multidisciplinary, integrated team including RNs, OTs and PTs.
Interventions
OTHERPalliative And supportive Care inTervention (PACT)
Using the Adaptive Leadership Framework for Chronic Illness as a guide. The nurse, occupational and physical therapists will meet with the patient and caregiver after the baseline assessment to discuss their Specific, Measurable, Achievable, Relevant, and Time-Bound (SMART) goals. Additionally, the occupational and physical therapists will provide the patient a PACT intervention binder. Regular phone calls or visits from a registered nurse, occupational therapists, and physical therapists for patients and caregivers in the intervention.
Sponsors
National Institute of Nursing Research (NINR)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a feasibility study. This study is conducted on one unit and to reduce bias and contamination, the control patients will be recruited and consented first. After recruitment of the 20 control patients, we will then recruit 20 intervention patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\[Patient\] Inclusion Criteria: 1. ≧60 years of age 2. Diagnosis of acute myeloid leukemia 3. Receive low-dose cytarabine or hypomethylating agent (HMA) in combination with Venetoclax chemotherapy 4. Speak and read English 5. Preference will be given to patients with care partners
Exclusion criteria
1\. Patients receiving hospice care \[Caregiver\] Inclusion Criteria: 1. ≧18 years of age 2. Identified by patient as caregiver 3. Speak and read English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Acceptability | Baseline | Feasibility and acceptability will be assessed as the number of participants who were approached, consented to, and eligible for the study. |
| Retention Rate | Baseline and up to 30 days (first and second cycles) | The rate of participants who consented to the study completed study intervention at the time point. |
| Symptom Monitoring Data Collection Rate | Baseline and up to 30 days (first and second cycles) | The number of participants who joined the study and symptom monitoring were assessed at the time point. |
| Caregiver Follow-Up Data Collection Rate | At second cycle (at days 30) | Caregiver Follow-Up data collection rate was assessed the number of caregiver participants who joined the study and symptom monitoring was assessed at the time points. |
| Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1. | Baseline, up to 30 days | Mean Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in control and intervention arms at Cycle 1. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and a global health and quality-of-life scale. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. |
| Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2. | 30 days after starting to the study | Mean Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in control and intervention arms at Cycle 2. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and a global health and quality-of-life scale. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. |
| Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores Between Cycle 1 and Cycle 2. | Baseline and until day 30 (Cycle 1 and Cycle 2) | Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in the intervention arm both at Cycle 1 and 2. Score difference for each subject and mean differences between scores were calculated. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. |
| Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Up to180 days | 19 items include diarrhea, chills, heartburn, nausea, appetite, mouth sores, vomiting, constipation, cough, rash, shortness of breath, fatigue, anxiety, sadness, nothing will cheer me up, pain, insomnia, concentration, and memory. The severity is assessed from None to Very severe and the interference level is assessed from Not at all to Very much. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 09/14/2020 through 04/06/2023 at one cancer center in North Carolina. Subjects were enrolled in the study between 09/14/2020 - 4/4/2023.
Pre-assignment details
A total of seventy-two participants consented to the study, but five of them withdrew their consent during screening and therefore were not enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Control Patients in the control arm will receive standard of care and no intervention. | 20 |
| Intervention Patients in the intervention arm will receive the PACT intervention. | 18 |
| Care Partner -Control Subjects who are family or friends or support patients in the control group | 14 |
| Care Partner- Interventional Subjects who are family or friends or support patients in the intervention group. | 15 |
| Total | 67 |
Baseline characteristics
| Characteristic | Control | Intervention | Care Partner- Interventional | Care Partner -Control | Total |
|---|---|---|---|---|---|
| Age, Continuous | 74.7 years STANDARD_DEVIATION 7.49 | 74 years STANDARD_DEVIATION 6.75 | 67.4 years STANDARD_DEVIATION 13.12 | 65.6 years STANDARD_DEVIATION 9.3 | 70.43 years STANDARD_DEVIATION 9.17 |
| Education 1st-8th grade | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Education 9-11th grade | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Education Advanced Degree | 6 Participants | 1 Participants | 1 Participants | 4 Participants | 12 Participants |
| Education College Degree | 4 Participants | 10 Participants | 5 Participants | 6 Participants | 25 Participants |
| Education High school graduate/GED | 9 Participants | 5 Participants | 7 Participants | 3 Participants | 24 Participants |
| Education Prefer not to answer | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 14 Participants | 14 Participants | 12 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 6 Participants |
| Marital Status Divorced | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 7 Participants |
| Marital Status Married/partnered | 14 Participants | 14 Participants | 14 Participants | 12 Participants | 54 Participants |
| Marital Status separated | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Marital Status Single, never married | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Marital Status widowed | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 13 Participants | 11 Participants | 13 Participants | 54 Participants |
| Region of Enrollment United States | 20 participants | 18 participants | 15 participants | 14 participants | 67 participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 12 Participants | 13 Participants | 53 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 3 Participants | 1 Participants | 14 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 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Caregiver Follow-Up Data Collection Rate
Caregiver Follow-Up data collection rate was assessed the number of caregiver participants who joined the study and symptom monitoring was assessed at the time points.
Time frame: At second cycle (at days 30)
Population: Caregivers of subjects started the study and responded the questions at the time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Potential - Eligible- Consented Participants | Caregiver Follow-Up Data Collection Rate | 10 Participants |
| Intervention | Caregiver Follow-Up Data Collection Rate | 12 Participants |
Primary
Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1.
Mean Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in control and intervention arms at Cycle 1. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and a global health and quality-of-life scale. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale.
Time frame: Baseline, up to 30 days
Population: Subjects who were joined to the study and completed assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Potential - Eligible- Consented Participants | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1. | Cycle1 Overall QoL | 55.8 score on a scale | Standard Deviation 22.6 |
| Potential - Eligible- Consented Participants | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1. | Cycle1 Physical QoL | 72.3 score on a scale | Standard Deviation 22.6 |
| Potential - Eligible- Consented Participants | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1. | Cycle1 Emotional QoL | 83.3 score on a scale | Standard Deviation 15.3 |
| Potential - Eligible- Consented Participants | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1. | Cycle1 Fatigue | 49.4 score on a scale | Standard Deviation 29.8 |
| Intervention | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1. | Cycle1 Fatigue | 53.1 score on a scale | Standard Deviation 30.1 |
| Intervention | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1. | Cycle1 Overall QoL | 52.8 score on a scale | Standard Deviation 25.7 |
| Intervention | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1. | Cycle1 Emotional QoL | 77.3 score on a scale | Standard Deviation 22.3 |
| Intervention | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1. | Cycle1 Physical QoL | 64.4 score on a scale | Standard Deviation 27.7 |
Primary
Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2.
Mean Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in control and intervention arms at Cycle 2. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and a global health and quality-of-life scale. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale.
Time frame: 30 days after starting to the study
Population: Subjects who were joined to the study and completed the assessment on Cycle 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Potential - Eligible- Consented Participants | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2. | Cycle2 Overall QoL | 64.4 score on a scale | Standard Deviation 16.8 |
| Potential - Eligible- Consented Participants | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2. | Cycle2 Physical QoL | 76.9 score on a scale | Standard Deviation 18 |
| Potential - Eligible- Consented Participants | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2. | Cycle2 Emotional QoL | 86.7 score on a scale | Standard Deviation 10.8 |
| Potential - Eligible- Consented Participants | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2. | Cycle2 Fatigue | 39.3 score on a scale | Standard Deviation 17.2 |
| Intervention | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2. | Cycle2 Fatigue | 54.0 score on a scale | Standard Deviation 30.5 |
| Intervention | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2. | Cycle2 Overall QoL | 60.1 score on a scale | Standard Deviation 20.5 |
| Intervention | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2. | Cycle2 Emotional QoL | 87.5 score on a scale | Standard Deviation 15.6 |
| Intervention | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2. | Cycle2 Physical QoL | 72.9 score on a scale | Standard Deviation 19.8 |
Primary
Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores Between Cycle 1 and Cycle 2.
Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in the intervention arm both at Cycle 1 and 2. Score difference for each subject and mean differences between scores were calculated. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale.
Time frame: Baseline and until day 30 (Cycle 1 and Cycle 2)
Population: Subjects who were joined to the study and responded to (EORTC QLQ-C30) questionnaire at Cycle 1 and Cycle 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Potential - Eligible- Consented Participants | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores Between Cycle 1 and Cycle 2. | Overall QOL | 5.36 score on a scale | Standard Deviation 26.27 |
| Potential - Eligible- Consented Participants | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores Between Cycle 1 and Cycle 2. | Physical QOL | 3.81 score on a scale | Standard Deviation 24.35 |
| Potential - Eligible- Consented Participants | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores Between Cycle 1 and Cycle 2. | Emotional QOL | 7.34 score on a scale | Standard Deviation 13.66 |
| Potential - Eligible- Consented Participants | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores Between Cycle 1 and Cycle 2. | Fatigue | 4.76 score on a scale | Standard Deviation 33.39 |
Primary
Feasibility and Acceptability
Feasibility and acceptability will be assessed as the number of participants who were approached, consented to, and eligible for the study.
Time frame: Baseline
Population: Potential research participants screened.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Potential - Eligible- Consented Participants | Feasibility and Acceptability | Screened | 128 Participants |
| Potential - Eligible- Consented Participants | Feasibility and Acceptability | Eligible | 93 Participants |
| Potential - Eligible- Consented Participants | Feasibility and Acceptability | Approached | 54 Participants |
| Potential - Eligible- Consented Participants | Feasibility and Acceptability | Consented | 38 Participants |
Primary
Retention Rate
The rate of participants who consented to the study completed study intervention at the time point.
Time frame: Baseline and up to 30 days (first and second cycles)
Population: Subjects started the study and completed the study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Potential - Eligible- Consented Participants | Retention Rate | Consented | 20 Participants |
| Potential - Eligible- Consented Participants | Retention Rate | Cycle 1 | 20 Participants |
| Potential - Eligible- Consented Participants | Retention Rate | Cycle 2 | 15 Participants |
| Intervention | Retention Rate | Consented | 18 Participants |
| Intervention | Retention Rate | Cycle 1 | 18 Participants |
| Intervention | Retention Rate | Cycle 2 | 15 Participants |
Primary
Symptom Monitoring Data Collection Rate
The number of participants who joined the study and symptom monitoring were assessed at the time point.
Time frame: Baseline and up to 30 days (first and second cycles)
Population: Subjects started the study and were assessed at the time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Potential - Eligible- Consented Participants | Symptom Monitoring Data Collection Rate | Cycle 1 | 17 Participants |
| Potential - Eligible- Consented Participants | Symptom Monitoring Data Collection Rate | Cycle 2 | 14 Participants |
| Intervention | Symptom Monitoring Data Collection Rate | Cycle 1 | 12 Participants |
| Intervention | Symptom Monitoring Data Collection Rate | Cycle 2 | 10 Participants |
Primary
Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
19 items include diarrhea, chills, heartburn, nausea, appetite, mouth sores, vomiting, constipation, cough, rash, shortness of breath, fatigue, anxiety, sadness, nothing will cheer me up, pain, insomnia, concentration, and memory. The severity is assessed from None to Very severe and the interference level is assessed from Not at all to Very much.
Time frame: Up to180 days
Population: Subjects started the study and responded to the PRO-CTCAE questionnaire at the time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | heartburn | 7 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | constipation | 10 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | diarrhea | 9 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | cough | 8 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | nausea | 8 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | anxiety | 9 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | fatigue | 12 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | sadness | 8 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | appetite | 11 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | nothing will cheer me up | 7 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | chills | 12 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | pain | 8 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | mouth sores | 8 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | insomnia | 11 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | shortness of breath | 9 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | concentration | 10 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | vomiting | 1 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | memory | 10 Participants |
| Potential - Eligible- Consented Participants | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | rash | 3 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | memory | 14 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | rash | 0 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | shortness of breath | 15 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | fatigue | 15 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | diarrhea | 13 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | chills | 15 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | heartburn | 13 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | nausea | 14 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | appetite | 15 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | mouth sores | 15 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | vomiting | 9 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | constipation | 15 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | cough | 15 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | anxiety | 14 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | sadness | 14 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | nothing will cheer me up | 11 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | pain | 8 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | insomnia | 15 Participants |
| Intervention | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | concentration | 14 Participants |