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

Dartmouth Health

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Effort-based exercise prescription; Behavioral: Core Exercise Promotion Program; Behavioral: Affect-based exercise prescription

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06258993

K08CA259632 (U.S. NIH Grant/Contract)

STUDY02000934_2

Details and patient eligibility

About

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.

Enrollment: 85 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Affect-based Exercise Prescription (Affect-Rx)

Experimental group

Treatment:

Behavioral: Affect-based exercise prescription

Behavioral: Core Exercise Promotion Program

Effort-based Exercise Prescription (RPE-Rx)

Active Comparator group

Treatment:

Behavioral: Effort-based exercise prescription

Behavioral: Core Exercise Promotion Program