Clinical trial NCT06073951: Evaluation of a Couple-Based Physical Activity Intervention
Official title: Mates in Motion: Feasibility and Acceptability of a Couple-Based Physical Activity Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-10-10
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Observed recruitment
timeFrame: At baseline
measure: Intervention adherence
timeFrame: 8 weeks
measure: Actigraph wear adherence
timeFrame: 8 weeks
measure: Garmin wear adherence
timeFrame: 8 weeks
measure: Retention
timeFrame: At 100 days post-hematopoietic cell transplant (HCT)
Secondary outcomes:
measure: Acceptability of the intervention
timeFrame: At 100 days post-hematopoietic cell transplant (HCT)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Nandita Khera, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: