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Completed

NCT Number: NCT06073951

Evaluation 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.

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Key information

Conditions

Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Exercise Counseling

Other

Receive walking step goals

Exercise intervention

Other

Participate in Mates in Motion program

Medical Device Usage and Evaluation

Other

Wear Actigraph

Physical Performance Testing

Other

Undergo walk-test

Other names: Physical Fitness Testing, Physical Function Testing

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. Observed recruitment

    Time frame: At baseline

    Will be assessed by the percentage of eligible patient-partner couples agreeing to participate

  2. Intervention adherence

    Time frame: 8 weeks

    Will be assessed by the number of intervention sessions attended.

  3. Actigraph wear adherence

    Time frame: 8 weeks

    Will be assessed by the number of valid wear days.

  4. Garmin wear adherence

    Time frame: 8 weeks

    Will be assessed by the number of valid wear days.

  5. Retention

    Time frame: At 100 days post-hematopoietic cell transplant (HCT)

    Will be assessed by the number of post-intervention follow-up assessments completed.

Secondary outcomes

  1. Acceptability of the intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2023
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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