Evaluation of a Couple-Based Physical Activity Intervention
- Conditions
- Hematopoietic and Lymphoid System NeoplasmMalignant Solid Neoplasm
- Interventions
- Other: Exercise CounselingOther: Best PracticeOther: Medical Device Usage and EvaluationOther: Exercise InterventionOther: Physical Performance TestingOther: Questionnaire Administration
- Registration Number
- NCT06073951
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
- PATIENTS: Age 18 years or older
- PATIENTS: Scheduled to receive an autologous or allogeneic hematopoietic cell transplant (HCT) or chimeric antigen receptor (CAR)-T cell therapy
- PATIENTS: Able to speak and comprehend English
- PATIENTS: Being married or in a committed (self-defined) cohabiting same- or opposite-sex relationship
- PATIENTS: Physician-approved for a walking program
- CAREGIVERS: Age 18 years or older
- CAREGIVERS: Able to speak and comprehend English
- CAREGIVERS: Married to or in a committed, cohabiting, same- or opposite-sex relationship with the patient
- CAREGIVERS: Able to participate in a walking program
- None per se beyond the converse of the inclusions listed above, for example, age younger than 18 years and non-partnered
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (Mates in Motion) Questionnaire Administration 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 (usual care) Physical Performance Testing 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. Arm II (usual care) Questionnaire Administration 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. Arm I (Mates in Motion) Physical Performance Testing 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 (usual care) Medical Device Usage and Evaluation 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. Arm I (Mates in Motion) Medical Device Usage and Evaluation 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 I (Mates in Motion) Exercise Counseling 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 (usual care) Best Practice 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. Arm I (Mates in Motion) Exercise Intervention 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.
- Primary Outcome Measures
Name Time Method Retention At 100 days post-hematopoietic cell transplant (HCT) Will be assessed by the number of post-intervention follow-up assessments completed.
Observed recruitment At baseline Will be assessed by the percentage of eligible patient-partner couples agreeing to participate
Intervention adherence 8 weeks Will be assessed by the number of intervention sessions attended.
Actigraph wear adherence 8 weeks Will be assessed by the number of valid wear days.
Garmin wear adherence 8 weeks Will be assessed by the number of valid wear days.
- Secondary Outcome Measures
Name Time Method Acceptability of the intervention At 100 days post-hematopoietic cell transplant (HCT) 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.
Trial Locations
- Locations (1)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States