Evaluation of a Couple-Based Physical Activity Intervention

Study Overview
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Brief Summary
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This clinical trial tests how well a couple-based physical activity (PA) intervention, Mates in Motion, works in patients undergoing hematopoietic cell transplantation (HCT) 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.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine feasibility of recruitment, adherence, and retention of a couple-based physical activity (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: Patient-partner 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 emphasis 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 Fitbit 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 Fitbit at the end of the study.

Official Title
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Mates in Motion: Feasibility and Acceptability of a Couple-Based Physical Activity Intervention

Conditions
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Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Best Practice
* Other: Exercise Counseling
* Other: Exercise Intervention
* Other: Medical Device Usage and Evaluation
* Other: Medical Device Usage and Evaluation
* Other: Physical Performance Testing
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PATIENTS: Age 18 years or older PATIENTS: Scheduled to receive an autologous or allogeneic hematopoietic cell transplant (HCT) 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: Able to participate in a walking program Exclusion Criteria: None per se beyond the converse of the inclusions listed above, for example, age younger than 18 years and non-partnered

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (Mates in Motion)<br>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 Fitbit on study. | Other: Exercise Counseling<br>* Receive walking step goals<br>Other: Exercise Intervention<br>* Participate in Mates in Motion program<br>Other: Medical Device Usage and Evaluation<br>* Wear Actigraph<br>Other: Medical Device Usage and Evaluation<br>* Wear Fitbit<br>Other: Physical Performance Testing<br>* Undergo walk-test<br>* Other names: Physical Function Testing;Other: Questionnaire Administration<br>* Complete questionnaires<br>|
| Active Comparator: Arm II (usual care)<br>Patient-partner dyads wear an Actigraph device, compete walk-tests and questionnaires on study. Dyads receive usual care on study. Dyads receive a Fitbit at the end of the study. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Medical Device Usage and Evaluation<br>* Wear Fitbit<br>Other: Physical Performance Testing<br>* Undergo walk-test<br>* Other names: Physical Function Testing;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed recruitment | Will be assessed by the percentage of eligible patient-partner couples agreeing to participate | At baseline | 
| Intervention adherence | Will be assessed by the number of intervention sessions attended. | 8 weeks | 
| Actigraph wear adherence | Will be assessed by the number of valid wear days. | 8 weeks | 
| Fitbit wear adherence | Will be assessed by the number of valid wear days. | 8 weeks | 
| Retention | Will be assessed by the number of post-intervention follow-up assessments completed. | At 100 days post-hematopoietic cell transplant (HCT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 100 days post-hematopoietic cell transplant (HCT) |