Evaluation of a Couple-Based Physical Activity Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm
• Intervention / Treatment: Other: Best Practice; Other: Questionnaire Administration; Other: Exercise Counseling; Other: Exercise Intervention; Other: Medical Device Usage and Evaluation; Other: Physical Performance Testing; Other: Medical Device Usage and Evaluation

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• None per se beyond the converse of the inclusions listed above, for example, age younger than 18 years and non-partnered

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (Mates in Motion); 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.	Other: Questionnaire Administration; Complete questionnaires; Other: Exercise Counseling; Receive walking step goals; Other: Exercise Intervention; Participate in Mates in Motion program; Other: Medical Device Usage and Evaluation; Wear Actigraph; Other: Physical Performance Testing; Undergo walk-test; Other Names: Physical Fitness Testing; Physical Function Testing; Other: Medical Device Usage and Evaluation; Wear Garmin activity tracker
Active Comparator: Arm II (usual care); 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.	Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Other: Questionnaire Administration; Complete questionnaires; Other: Medical Device Usage and Evaluation; Wear Actigraph; Other: Physical Performance Testing; Undergo walk-test; Other Names: Physical Fitness Testing; Physical Function Testing; Other: Medical Device Usage and Evaluation; Wear Garmin activity tracker

What is the study measuring?

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
Retention	Will be assessed by the number of post-intervention follow-up assessments completed.	At 100 days post-hematopoietic cell transplant (HCT)
Garmin wear adherence	Will be assessed by the number of valid wear days.	8 weeks

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)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Nandita Khera, MD, MPH, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Actual): September 3, 2025
• Study Completion (Actual): September 3, 2025

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Quality of Health Care; Quality Indicators, Health Care; Diagnostic Techniques, Respiratory System; Diagnostic Techniques, Cardiovascular; Guidelines as Topic; Quality Assurance, Health Care; Heart Function Tests; Respiratory Function Tests; Ergometry; Standard of Care; Practice Guidelines as Topic; Exercise Test
• Other Study ID Numbers: 23-008130 (Other Identifier: Mayo Clinic in Arizona); NCI-2023-07197 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R21CA275085-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No