Evaluation of a Couple-Based Physical Activity Intervention

Mayo Clinic

Status: Completed

Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06073951

NCI-2023-07197 (Registry Identifier)

23-008130 (Other Identifier)

R21CA275085-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Arm I (Mates in Motion)

Experimental group

Description:

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.

Treatment:

Other: Medical Device Usage and Evaluation

Other: Physical Performance Testing

Other: Exercise Intervention

Other: Questionnaire Administration

Other: Exercise Counseling

Other: Medical Device Usage and Evaluation

Arm II (usual care)

Active Comparator group

Description:

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.

Treatment:

Other: Medical Device Usage and Evaluation

Other: Best Practice

Other: Physical Performance Testing

Other: Questionnaire Administration

Other: Medical Device Usage and Evaluation