Evaluation of a Couple-Based Physical Activity Intervention

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073951
• Other study ID #: 23-008130
• Secondary ID: NCI-2023-0719723
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) 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.

Description:

PRIMARY OBJECTIVES:

I. To determine feasibility of recruitment, adherence, and retention of a couple-based physical activity (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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PATIENTS: Age 18 years or older

• PATIENTS: Scheduled to receive an autologous or allogeneic hematopoietic cell transplant (HCT)

• 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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Best Practice
Receive usual care
• Exercise Counseling
Receive walking step goals
• Exercise Intervention
Participate in Mates in Motion program
• Medical Device Usage and Evaluation
Wear Actigraph
• Medical Device Usage and Evaluation
Wear Garmin activity tracker
• Physical Performance Testing
Undergo walk-test
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observed recruitment	Will be assessed by the percentage of eligible patient-partner couples agreeing to participate	At baseline
Primary	Intervention adherence	Will be assessed by the number of intervention sessions attended.	8 weeks
Primary	Actigraph wear adherence	Will be assessed by the number of valid wear days.	8 weeks
Primary	Garmin wear adherence	Will be assessed by the number of valid wear days.	8 weeks
Primary	Retention	Will be assessed by the number of post-intervention follow-up assessments completed.	At 100 days post-hematopoietic cell transplant (HCT)
Secondary	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)