A Randomized Two-Arm Proof of Concept Study Testing A Novel Approach to Exercise Promotion Based on Affect-regulation

Trial Title: A Randomized Two-Arm Proof of Concept Study Testing A Novel Approach to Exercise Promotion Based on Affect-regulation

NCT ID: NCT06258993

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Core Exercise Promotion Program
Description: Core intervention content will be delivered during the Visit 1 and 1-Month-Check-in meetings. Definitions of exercise will be provided, participants will be asked to discuss their past experiences with exercise, guidelines for being safe during exercise will be reviewed, and strategies for overcoming potential barriers to exercise will be discussed. All participants will be given an exercise plan organized according to the FIIT Principle (Frequency, Intensity, Time, and Type). The intensity component of the exercise plan will differ by study arm, all other elements will be delivered the same across both conditions. All participants will be given the goal of increasing weekly time spent exercising to ≥150 minutes, consistent with recommended guidelines. All participants will be given a smartwatch to support self-monitoring of exercise and activity levels throughout the 12-week study period.
Arm group label: Affect-based Exercise Prescription (Affect-Rx)
Arm group label: Effort-based Exercise Prescription (RPE-Rx)

Intervention type: Behavioral
Intervention name: Affect-based exercise prescription
Description: Participants assigned to Affect-Rx will receive instructions to "select a pace of exercise that makes you feel as good as possible." The exercise intensity prescription section of their exercise plan will include the Feeling Scale as an attachment and participants will be given the instruction to "stay in the green zone" on the Feeling Scale.
Arm group label: Affect-based Exercise Prescription (Affect-Rx)

Intervention type: Behavioral
Intervention name: Effort-based exercise prescription
Description: Participants assigned to RPE-Rx will receive instructions to "select a pace that would make it challenging for you to carry on more than a short conversation." The exercise intensity prescription section of their exercise plan will include the Rating of Perceived Exertion (RPE) scale as an attachment and participants will be given the instruction to "stay in the green zone" on the RPE Scale.
Arm group label: Effort-based Exercise Prescription (RPE-Rx)

Summary: The goal of this clinical trial is to test the effect of an affect-based exercise prescription on moderate-vigorous physical activity participation among survivors of breast cancer who completed primary treatment within the last 5 years. The main questions it aims to answer are: 1. Do at least 50% of participants assigned to the affect-based exercise prescription engage in ≥90 minutes of moderate-vigorous physical activity by the end of 12-weeks follow-up? 2. What level of satisfaction do breast cancer survivors who receive the affect-based exercise prescription report relative to breast cancer survivors who receive an effort-based exercise prescription. 3. What proportion of participants assigned to the affect-based exercise prescription stay enrolled in the study relative to the number of participants who stay enrolled in the effort-based exercise prescription. All participants will: - Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription. - Participate in two meetings with a member of the study team meant to help them get started increasing weekly exercise. These meetings are the same for all participants. - Be asked to wear an activity monitor and respond to brief surveys for 10 straight days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - ≥18 years old - Within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for Stage 0-III breast cancer - <60 mins/week moderate-vigorous physical activity (MVPA) with no major changes for the past 6- months - Own an Android or iPhone smartphone (or tablet) and willing to use it to complete app-based surveys during assessment periods - Willing to wear the ActiGraph monitor during assessment periods - Access to internet to complete REDCap survey assessments Exclusion Criteria: - Non-English speaking/not able to read English - Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+) - Currently pregnant - History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium) - Evidence of moderate-severe depressive symptoms (indicated by a score≥ 10 on the Patient Health Questionnaire-8) - Evidence of moderate-severe cognitive impairment (indicated by a score < 3 on a 6-item cognitive screener) - Evidence of clinically significant substance use as indicated by a score of ≥ 2 on the CAGE- AID screener.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Dartmouth-Hitchcock Clinic

Address:
City: Lebanon
Zip: 03756
Country: United States

Status: Recruiting

Contact:
Last name: Courtney J Stevens, PhD

Phone: 603-646-5451
Email: courtney.j.stevens@dartmouth.edu

Start date: April 16, 2024

Completion date: April 1, 2026

Lead sponsor:
Agency: Dartmouth-Hitchcock Medical Center
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Dartmouth-Hitchcock Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06258993