Evaluation of a Couple-Based Physical Activity Intervention

NCT06073951 | Completed

• 3 other identifiers: 23-008130NCI-2023-07197R21CA275085-01A1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (5)

• 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

• Garmin 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 Outcomes (1)

• Acceptability of the intervention

  At 100 days post-hematopoietic cell transplant (HCT)

Study Arms (2)

Arm I (Mates in Motion)

EXPERIMENTAL

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: Exercise Counseling; Other: Exercise Intervention; Other: Medical Device Usage and Evaluation; Other: Physical Performance Testing; Other: Questionnaire Administration

Arm II (usual care)

ACTIVE COMPARATOR

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; Other: Medical Device Usage and Evaluation; Other: Physical Performance Testing; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm II (usual care)

Exercise Counseling OTHER

Receive walking step goals

Arm I (Mates in Motion)

Exercise Intervention OTHER

Participate in Mates in Motion program

Arm I (Mates in Motion)

Medical Device Usage and Evaluation OTHER

Wear Actigraph

Arm I (Mates in Motion)

Physical Performance Testing OTHER

Undergo walk-test

Also known as: Physical Fitness Testing, Physical Function Testing

Arm I (Mates in Motion); Arm II (usual care)

Questionnaire Administration OTHER

Complete questionnaires

Arm I (Mates in Motion); Arm II (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Exercise Test

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Nandita Khera, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 10, 2023
• Study Start: March 11, 2024
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

US (1)