This clinical trial tests how well a couple-based physical activity (PA) intervention, Mates in Motion, works in patients undergoing hematopoietic cell transplantation (HCT) or chimeric antigen receptor T-cell therapy (CART) and their care giving partners to be more physically active. Mates in Motion provides training in communication skills and behavior change techniques to help HCT patient-caregiver dyads support one another in adoption and maintenance of PA. This study may help researchers determine if a couple-based PA intervention improves PA, physical endurance and global physical health among patient-care giver dyads undergoing HCT or CART.
PRIMARY OBJECTIVES: I. To determine feasibility of recruitment, adherence, and retention of a couple-based PA intervention in a pilot randomized controlled trial (RCT). II. Determine acceptability of the intervention (multiple dimensions of treatment satisfaction). III. Describe changes in PA, physical endurance, and global physical health from baseline to follow-up as a function of randomized condition. OUTLINE: Patient-caregiver dyads are randomized to 1 of 2 arms. ARM I: Dyads participate in the Mates in Motion program consisting of weekly sessions to train couples in the use of communal coping strategies to support one another in achieving PA goals and skill building focus on instruction and practice in effective communication, with emphases on adaptive speaking, responsive listening, and joint decision-making and problem-solving around PA over 8 weeks. Patient-partner dyads receive weekly step-count goals, complete walk-tests and questionnaires and wear an Actigraph device and Garmin activity tracker on study. ARM II: Patient-partner dyads wear an Actigraph device, compete walk-tests and questionnaires on study. Dyads receive usual care on study. Dyads receive a Garmin activity tracker at the end of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
96
Receive usual care
Receive walking step goals
Participate in Mates in Motion program
Wear Actigraph
Wear Garmin activity tracker
Undergo walk-test
Complete questionnaires
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Observed recruitment
Will be assessed by the percentage of eligible patient-partner couples agreeing to participate
Time frame: At baseline
Intervention adherence
Will be assessed by the number of intervention sessions attended.
Time frame: 8 weeks
Actigraph wear adherence
Will be assessed by the number of valid wear days.
Time frame: 8 weeks
Garmin wear adherence
Will be assessed by the number of valid wear days.
Time frame: 8 weeks
Retention
Will be assessed by the number of post-intervention follow-up assessments completed.
Time frame: At 100 days post-hematopoietic cell transplant (HCT)
Acceptability of the intervention
Will be assessed among patients and caregivers and will examine ratings for the following treatment satisfaction domains relative to the scale midpoint: suitability, utility, attitude toward treatment, desire for continued treatment use, therapist competence, therapist interpersonal style, format and dose, and perceived benefits.
Time frame: At 100 days post-hematopoietic cell transplant (HCT)
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