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

NCT06258993 | Recruiting DMC

• 2 other identifiers: STUDY02000934_2K08CA259632
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up

  The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.

  2-weeks follow-up assessment.

• Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up

  The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.

  6-weeks follow-up assessment.

• Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up

  The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.

  12-weeks follow-up assessment.

Secondary Outcomes (8)

• Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire

  12-weeks follow-up assessment.

• Study Retention at 2-weeks Follow-up

  2-weeks follow-up assessment.

• Study Retention at 6-weeks Follow-up

  6-weeks follow-up assessment.

• Study Retention at 12-weeks Follow-up

  12-weeks follow-up assessment.

• Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure

  12-weeks follow-up assessment.

Other Outcomes (8)

• Change Overtime in Cancer-related Fatigue Measured Using the PROMIS Fatigue Short Form 8a

  Baseline and 12-weeks follow-up assessments.

• Change Overtime in Health-related Quality of Life Measured Using the PROMIS Global Health Scale

  Baseline and 12-weeks follow-up assessments.

• Change Overtime in Physical Functioning Measured Using The PROMIS Physical Function Short Form 8a

  Baseline and 12-weeks follow-up assessments.

Study Arms (2)

Affect-based Exercise Prescription (Affect-Rx)

EXPERIMENTAL

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

Effort-based Exercise Prescription (RPE-Rx)

ACTIVE COMPARATOR

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

Interventions

Core Exercise Promotion Program BEHAVIORAL

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.

Affect-based Exercise Prescription (Affect-Rx); Effort-based Exercise Prescription (RPE-Rx)

Affect-based exercise prescription BEHAVIORAL

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.

Affect-based Exercise Prescription (Affect-Rx)

Effort-based exercise prescription BEHAVIORAL

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.

Effort-based Exercise Prescription (RPE-Rx)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Courtney J Stevens, PhD

  Dartmouth-Hitcock Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney J Stevens, PhD

CONTACT

6036509643; courtney.j.stevens@dartmouth.edu

Aislinn E Mitcham, BA

CONTACT

6036466545; aislinn.e.mitcham@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: April 16, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)