Prehabilitation in Patients With Multiple Myeloma Receiving CAR-T Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Retention rate
研究概览
简要总结
This clinical trial evaluates whether prehabilitation with aerobic and resistance exercise improves physical fitness and quality of life outcomes in older patients planning to undergo chimeric antigen receptor (CAR)-T therapy for multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CAR-T therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. Large numbers of the CAR-T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. While CAR-T therapy is commonly used to treat multiple myeloma, it can result in toxicities that lead to hospitalization, nerve and muscle impairment, and decreased physical function. Prehabilitation programs use targeted interventions to improve functional status prior to medical or surgical treatments. In this study, patients participate in personalized aerobic and resistance prehabilitation activities in the weeks leading up to their CAR-T infusion. This program may improve physical fitness and quality of life, both prior to and after CAR-T infusion, in older patients with relapsed or refractory multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple myeloma diagnosis
- •Females and males ≥ 60 years of age
- •Eastern Cooperative Oncology Group (ECOG) score of < 3
- •Scheduled for a CAR T therapy transfusion
- •Apheresis date at least 7 days prior to date of enrollment
- •Primary hematologist attending physician clearance for exercise
排除标准
- •Females or males < 60 years of age
- •Any hematological cancer other than multiple myeloma
- •Evidence of an absolute contraindication [e.g., heart insufficiency > New York Heart Association (NYHA) III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability for exercise]
- •Other comorbidities that preclude participation in the exercise as deemed by physical therapist or physical medicine and rehabilitation (PM&R) physician
- •Active infections, active bleeding disorders, and cytopenias at risk for further adverse events deemed by hematologist-oncologist
研究组 & 干预措施
Supportive care (aerobic and resistance training)
Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study.
干预措施: Accelerometry (Procedure)
Supportive care (aerobic and resistance training)
Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study.
干预措施: Aerobic Exercise (Other)
Supportive care (aerobic and resistance training)
Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study.
干预措施: Biospecimen Collection (Procedure)
Supportive care (aerobic and resistance training)
Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study.
干预措施: Electronic Health Record Review (Other)
Supportive care (aerobic and resistance training)
Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study.
干预措施: Exercise Counseling (Other)
Supportive care (aerobic and resistance training)
Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study.
干预措施: Internet-Based Intervention (Other)
Supportive care (aerobic and resistance training)
Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study.
干预措施: Interview (Other)
Supportive care (aerobic and resistance training)
Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study.
干预措施: Physical Performance Testing (Other)
Supportive care (aerobic and resistance training)
Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study.
干预措施: Resistance Training (Other)
Supportive care (aerobic and resistance training)
Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study.
干预措施: Tailored Intervention (Procedure)
Supportive care (aerobic and resistance training)
Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study.
干预措施: Survey Administration (Other)
结局指标
主要结局
Retention rate
时间窗: Up to 30 days post-chimeric antigen receptor (CAR)-T infusion
Retention rate will be evaluated as the proportion of enrolled patients who complete assessments at visit 2 (at 2 days prior to CAR-T infusion) and visit 3 (30 days post-CAR-T infusion).
Program completion
时间窗: Up to 30 days post-CAR-T infusion
Will be evaluated according to the completion of weekly phone calls, the frequency, intensity, and duration of exercise engagement, and accelerometer summary outcomes. The program will be considered feasible if there is \> 70% program completion, based on weekly phone calls.
Incidence of adverse events
时间窗: Up to 30 days post-CAR-T infusion
The program will be considered feasible if there are no serious adverse events due to the intervention.
Patient satisfaction
时间窗: Up to 30 days post-CAR-T infusion
Patient satisfaction will be determined using post-program satisfaction phone interviews. Qualitative interviews will be analyzed using thematic analysis.
Change in muscle strength
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed as grip strength, as measured (in kg) by maximal force generated by forearm muscles using calibrated handheld dynamometer
Change in muscle mass
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed via SOZO by ImpediMed \[bioimpedance spectroscopy (BIS)\] and Positron Emission Tomography (PET) Computed Tomography (CT) CT scan images, obtained as part of the patient's usual care.
Change in quality of life - EORTC QLQ-C30
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, a 30-item questionnaire where 28 questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, and 4= very much) and 2 two questions are answered on a scale of 1-7 (1= very poor and 7=excellent). Higher summary scores indicate better health related quality of life.
Change in physical activity - monitor
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed using Polar heart rate monitor with data collected through the Connected mHealth app.
Change in physical activity - RPE Scale
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed using patient self-reported Rate of Perceived Exertion (RPE) scale score within the Connected mHealth app after exercise: 1=very light activity; 2-3=light activity; 4-5=moderate activity; 7-8=vigorous activity; 9=very hard activity; and 10=maximal effort.
Changes in frailty status - IMWG-FI
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed using International Myeloma Working Group (IMWG) Frailty Index (FI) scores. The IMWG-FI assigns scores based on age, comorbidities, and the ability to perform activities of daily living (ADL) and instrumental activities of daily living (IADL). Patients are categorized as follows: Fit: Score of 0; Intermediate-fit: Score of 1; Frail: Score of 2 or higher.
Enrollment rate
时间窗: Up to 1 year
Enrollment rate will be evaluated as the number of patients eligible versus the number of patients enrolled.
Changes in frailty status - FP
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
The Fried frailty phenotype (FP) defines frailty as the presence of three or more of the following: unintentional weight loss ≥10 lb in previous year; self-reported exhaustion; weakness measured by grip strength; slow walking speed ;and low physical activity (less than 3 days of physical activity per week defined by the Department of Health Services \& Human Services). The presence of: 1) ≥3 criteria indicates frail status, 2) 1 or 2 criteria indicates intermediate or pre-frail status, and 3) 0 criteria indicates robust status.
Enrollment rate
时间窗: Up to 1 year
Enrollment rate will be evaluated as the number of patients eligible versus the number of patients enrolled.
Change in physical activity - RPE Scale
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed using patient self-reported Rate of Perceived Exertion (RPE) scale score within the Connected mHealth app after exercise: 1=very light activity; 2-3=light activity; 4-5=moderate activity; 7-8=vigorous activity; 9=very hard activity; and 10=maximal effort.
Changes in frailty status - IMWG-FI
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed using International Myeloma Working Group (IMWG) Frailty Index (FI) scores. The IMWG-FI assigns scores based on age, comorbidities, and the ability to perform activities of daily living (ADL) and instrumental activities of daily living (IADL). Patients are categorized as follows: Fit: Score of 0; Intermediate-fit: Score of 1; Frail: Score of 2 or higher.
Retention rate
时间窗: Up to 30 days post-chimeric antigen receptor (CAR)-T infusion
Retention rate will be evaluated as the proportion of enrolled patients who complete assessments at visit 2 (at 2 days prior to CAR-T infusion) and visit 3 (30 days post-CAR-T infusion).
Program completion
时间窗: Up to 30 days post-CAR-T infusion
Will be evaluated according to the completion of weekly phone calls, the frequency, intensity, and duration of exercise engagement, and accelerometer summary outcomes. The program will be considered feasible if there is \> 70% program completion, based on weekly phone calls.
Incidence of adverse events
时间窗: Up to 30 days post-CAR-T infusion
The program will be considered feasible if there are no serious adverse events due to the intervention.
Patient satisfaction
时间窗: Up to 30 days post-CAR-T infusion
Patient satisfaction will be determined using post-program satisfaction phone interviews. Qualitative interviews will be analyzed using thematic analysis.
Change in muscle mass
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed via SOZO by ImpediMed \[bioimpedance spectroscopy (BIS)\] and Positron Emission Tomography (PET) Computed Tomography (CT) CT scan images, obtained as part of the patient's usual care.
Change in quality of life - EORTC QLQ-C30
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, a 30-item questionnaire where 28 questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, and 4= very much) and 2 two questions are answered on a scale of 1-7 (1= very poor and 7=excellent). Higher summary scores indicate better health related quality of life.
Change in muscle strength
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed as grip strength, as measured (in kg) by maximal force generated by forearm muscles using calibrated handheld dynamometer
Change in physical performance
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed via short physical performance test (approximately 90 minutes) followed by wearing an activity monitor (Actigraph) for 7 days following each of 3 in-person physical assessments. Participants receive a postage-paid envelope to return the monitor after wearing it.
Change in physical activity - monitor
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed using Polar heart rate monitor with data collected through the Connected mHealth app.
Changes in frailty status - FP
时间窗: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
The Fried frailty phenotype (FP) defines frailty as the presence of three or more of the following: unintentional weight loss ≥10 lb in previous year; self-reported exhaustion; weakness measured by grip strength; slow walking speed ;and low physical activity (less than 3 days of physical activity per week defined by the Department of Health Services \& Human Services). The presence of: 1) ≥3 criteria indicates frail status, 2) 1 or 2 criteria indicates intermediate or pre-frail status, and 3) 0 criteria indicates robust status.
次要结局
未报告次要终点