Back to resultsExercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For CAR-T Cell Immunotherapy
Primary Purpose
Lymphoma, Leukemia, Myeloma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Training
Aerobic Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Lymphoma
Eligibility Criteria
Inclusion Criteria: Age ≥65 years Lymphoma, leukemia, or myeloma with commercial FDA-approved CAR-T delivery planned for ≥4 weeks following enrollment Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Able to read and speak English fluently Capable of providing informed consent Exclusion Criteria: Regular engagement in Resistance training (2x/week targeting all major muscle groups) Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and Patient-Reported Measurement Information System (PROMIS) screening questions Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV). Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT using body weight Numeric pain rating scale of ≥ 7 out of 10 Myopathic or rheumatologic disease that impacts physical function Cognitive, visual, or auditory limitations that preclude safe engagement in remotely-supervised resistance training sessions or independent aerobic exercise (as determined by patients' treating oncologists and specified in clinic notes outlining disease history).
Sites / Locations
- Moffitt Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise prehabilitation
Arm Description
Participants will take part in an exercise program in which they will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week until they undergo CAR-T therapy (Approximately 4-6 weeks). Participants will also be encouraged to perform moderate aerobic exercise such as brisk walking or using stationary aerobic equipment at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise.
Outcomes
Primary Outcome Measures
Percentage of Participants that Enroll and Consent - Enrollment Feasibility
Enrollment will be considered feasible if ≥60% of eligible and approached patients actually consent and enroll
Percentage of Participants that Complete Study Assessments - Retention Feasibility
Retention will be considered feasible if ≥70% of participants complete study measures
Adherence - Feasibility
Adherence will be based on participants attending ≥ 70% of tele-RT sessions on average and performing ≥ 70% of prescribed moderate-intensity aerobic exercise per week
Participant Evaluation of Feasibility and Acceptability - Acceptability
Participants evaluation of feasibility and acceptability will be assessed with a questionnaire, adapted to fit the intervention. The questionnaire includes both Likert Scale and open-ended questions. An item-by-item basis and as average item score, with scores ≥4 ("agree" to "strongly agree") indicating acceptability. Open-ended responses will be analyzed qualitatively to inform intervention improvement.
Participant Self-Reported Musculoskeletal Injuries - Safety
The numerator of the safety variable will be the number of musculoskeletal injuries or adverse health events reported as "likely related" or "definitely related" the exercise programming and that caused at least some limitation of daily activity lasting more than 3 days. The denominator of the safety variable will be the number of exercise sessions performed by the participant (tele-resistance training plus aerobic exercise sessions lasting ≥10 minutes). The intervention will be considered safe if the rate of musculoskeletal injuries (i.e., muscle strains or pulls, sprains, exacerbated bone pain, fractures or breaks, or other adverse health events incurred during exercise sessions) is lower than the published metric of 11.9 injuries per 1000 sessions, as used as a benchmark in previous exercise oncology research
Objective physical functioning and fitness - Baseline
Physical functioning and fitness will be assessed using the 30-second chair stand test,30-second arm curl test, and treadmill 6-minute walk test.
Objective physical functioning and fitness - Follow-up
Physical functioning and fitness will be assessed using the 30-second chair stand test,30-second arm curl test, and treadmill 6-minute walk test.
Participant Skeletal Muscle Index (SMI) - Baseline
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
Participant Skeletal Muscle Index (SMI) - Follow-up
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
Participants Health-Related Quality of Life - Baseline
Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
Participants Health-Related Quality of Life - At 3 Months
Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
Participants Health-Related Quality of Life - At 6 Months
Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
Participant Self Reported Exercise - Baseline
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Participant Self Reported Exercise - At 3 Months
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Participant Self Reported Exercise - At 6 Months
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Secondary Outcome Measures
Full Information
NCT ID
NCT05763563
First Posted
February 28, 2023
Last Updated
July 28, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Cancer and Aging Research Group
1. Study Identification
Unique Protocol Identification Number
NCT05763563
Brief Title
Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For CAR-T Cell Immunotherapy
Official Title
Feasibility Of Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For Chimeric Antigen Receptor (CAR) T-Cell Immunotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Cancer and Aging Research Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate an exercise program for individuals preparing for Chimeric Antigen Receptor (CAR) T-cell immunotherapy for hematological malignancies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Leukemia, Myeloma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise prehabilitation
Arm Type
Experimental
Arm Description
Participants will take part in an exercise program in which they will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week until they undergo CAR-T therapy (Approximately 4-6 weeks). Participants will also be encouraged to perform moderate aerobic exercise such as brisk walking or using stationary aerobic equipment at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise.
Intervention Type
Behavioral
Intervention Name(s)
Resistance Training
Intervention Description
Participants will be encouraged to perform approximately 30 minutes of resistance training exercises twice per week, until they undergo CART-T therapy. Exercises will be performed using resistance tubes (Bodylastics Resistance Bands Set) and a connectable bar (Bionic Body Workout Bar) that mimics a weighted barbell when tubes are attached. The tubes provide up to 142 pounds of resistance (adjustable in increments between 3-10 pounds) when simultaneously connected to handles or bar, and multiple tubes can be attached simultaneously.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
Participants will be encouraged to perform ≥30 minutes of moderate-intensity aerobic exercise on ≥3 days per week. Aerobic exercise intensity will be guided by heart rate zones, with participants exercising at 50-70% of their age-predicted maximum heart rate in bouts of at least 10 minutes at a time. Participants will be encouraged to gradually increase exercise intensity and duration until they are meeting the recommendation
Primary Outcome Measure Information:
Title
Percentage of Participants that Enroll and Consent - Enrollment Feasibility
Description
Enrollment will be considered feasible if ≥60% of eligible and approached patients actually consent and enroll
Time Frame
Up to 12 Months
Title
Percentage of Participants that Complete Study Assessments - Retention Feasibility
Description
Retention will be considered feasible if ≥70% of participants complete study measures
Time Frame
Up to 3 Months
Title
Adherence - Feasibility
Description
Adherence will be based on participants attending ≥ 70% of tele-RT sessions on average and performing ≥ 70% of prescribed moderate-intensity aerobic exercise per week
Time Frame
Up to 3 Months
Title
Participant Evaluation of Feasibility and Acceptability - Acceptability
Description
Participants evaluation of feasibility and acceptability will be assessed with a questionnaire, adapted to fit the intervention. The questionnaire includes both Likert Scale and open-ended questions. An item-by-item basis and as average item score, with scores ≥4 ("agree" to "strongly agree") indicating acceptability. Open-ended responses will be analyzed qualitatively to inform intervention improvement.
Time Frame
Up to 3 Months
Title
Participant Self-Reported Musculoskeletal Injuries - Safety
Description
The numerator of the safety variable will be the number of musculoskeletal injuries or adverse health events reported as "likely related" or "definitely related" the exercise programming and that caused at least some limitation of daily activity lasting more than 3 days. The denominator of the safety variable will be the number of exercise sessions performed by the participant (tele-resistance training plus aerobic exercise sessions lasting ≥10 minutes). The intervention will be considered safe if the rate of musculoskeletal injuries (i.e., muscle strains or pulls, sprains, exacerbated bone pain, fractures or breaks, or other adverse health events incurred during exercise sessions) is lower than the published metric of 11.9 injuries per 1000 sessions, as used as a benchmark in previous exercise oncology research
Time Frame
Up to 3 Months
Title
Objective physical functioning and fitness - Baseline
Description
Physical functioning and fitness will be assessed using the 30-second chair stand test,30-second arm curl test, and treadmill 6-minute walk test.
Time Frame
At Baseline
Title
Objective physical functioning and fitness - Follow-up
Description
Physical functioning and fitness will be assessed using the 30-second chair stand test,30-second arm curl test, and treadmill 6-minute walk test.
Time Frame
Up to 3 Months
Title
Participant Skeletal Muscle Index (SMI) - Baseline
Description
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
Time Frame
Baseline
Title
Participant Skeletal Muscle Index (SMI) - Follow-up
Description
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
Time Frame
After CAR-T Therapy, Up to 6 Months
Title
Participants Health-Related Quality of Life - Baseline
Description
Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
Time Frame
Baseline
Title
Participants Health-Related Quality of Life - At 3 Months
Description
Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
Time Frame
Up to 3 Months
Title
Participants Health-Related Quality of Life - At 6 Months
Description
Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
Time Frame
Up to 6 Months
Title
Participant Self Reported Exercise - Baseline
Description
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Time Frame
Baseline
Title
Participant Self Reported Exercise - At 3 Months
Description
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Time Frame
Up to 3 Months
Title
Participant Self Reported Exercise - At 6 Months
Description
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Time Frame
Up to 6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥65 years
Lymphoma, leukemia, or myeloma with commercial FDA-approved CAR-T delivery planned for ≥4 weeks following enrollment
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Able to read and speak English fluently
Capable of providing informed consent
Exclusion Criteria:
Regular engagement in Resistance training (2x/week targeting all major muscle groups)
Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and Patient-Reported Measurement Information System (PROMIS) screening questions
Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV).
Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT using body weight
Numeric pain rating scale of ≥ 7 out of 10
Myopathic or rheumatologic disease that impacts physical function
Cognitive, visual, or auditory limitations that preclude safe engagement in remotely-supervised resistance training sessions or independent aerobic exercise (as determined by patients' treating oncologists and specified in clinic notes outlining disease history).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan Parker, PhD, MPH
Phone
813-745-4673
Email
Nathan.Parker@moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Parker, PhD, MPH
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ciara Freeman, MD, PhD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Carmella
Phone
813-745-0956
Email
rachel.carmella@moffitt.org
First Name & Middle Initial & Last Name & Degree
Nathan Parker, PhD, MPH
First Name & Middle Initial & Last Name & Degree
Ciara Freeman, MD, PhD
First Name & Middle Initial & Last Name & Degree
Frederick Locke, MD
First Name & Middle Initial & Last Name & Degree
Michael Jain, MD, PhD
First Name & Middle Initial & Last Name & Degree
Julio Chavez, MD, MS
First Name & Middle Initial & Last Name & Degree
Bijal Shah, MD, MS
First Name & Middle Initial & Last Name & Degree
Omar Casteneda Pugliani, MD
First Name & Middle Initial & Last Name & Degree
Doris Hansen, MD
First Name & Middle Initial & Last Name & Degree
Taiga Nishihori, MD
First Name & Middle Initial & Last Name & Degree
Melissa Alsina, MD
First Name & Middle Initial & Last Name & Degree
Brandon Blue, MD
First Name & Middle Initial & Last Name & Degree
Rachid Baz, MD
First Name & Middle Initial & Last Name & Degree
Rawan Faramand, MD
First Name & Middle Initial & Last Name & Degree
Heather Jim, PhD
First Name & Middle Initial & Last Name & Degree
Laura Oswald, PhD
First Name & Middle Initial & Last Name & Degree
Jongphil Kim, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://moffitt.org/clinicaltrialssearch?DiseaseSite=&q=22115
Description
Moffitt Cancer Center Clinical Trial Search
Learn more about this trial
Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For CAR-T Cell Immunotherapy
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