RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Increasing Physical Activity Among Breast Cancer Survivors: Use of the ORBIT Model to Refine and Test a Novel Approach to Exercise Promotion Based on Affect-regulation (Study 2)

Quick Facts

Study Start:2024-04-16
Study Completion:2026-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06258993

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years old
  2. * Within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for Stage 0-III breast cancer
  3. * \<60 mins/week moderate-vigorous physical activity (MVPA) with no major changes for the past 6- months
  4. * Own an Android or iPhone smartphone (or tablet) and willing to use it to complete app-based surveys during assessment periods
  5. * Willing to wear the ActiGraph monitor during assessment periods
  6. * Access to internet to complete REDCap survey assessments
  1. * Non-English speaking/not able to read English
  2. * Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)
  3. * Currently pregnant
  4. * History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium)
  5. * Evidence of moderate-severe depressive symptoms (indicated by a score≥ 10 on the Patient Health Questionnaire-8)
  6. * Evidence of moderate-severe cognitive impairment (indicated by a score \< 3 on a 6-item cognitive screener)
  7. * Evidence of clinically significant substance use as indicated by a score of ≥ 2 on the CAGE- AID screener.

Contacts and Locations

Study Contact

Courtney J Stevens, PhD
CONTACT
6036509643
courtney.j.stevens@dartmouth.edu
Hollin R Hakimian, BA
CONTACT
6036465479
hollin.r.hakimian@hitchcock.org

Principal Investigator

Courtney J Stevens, PhD
PRINCIPAL_INVESTIGATOR
Dartmouth-Hitcock Health

Study Locations (Sites)

Dartmouth-Hitchcock Clinic
Lebanon, New Hampshire, 03756
United States

Collaborators and Investigators

Sponsor: Dartmouth-Hitchcock Medical Center

  • Courtney J Stevens, PhD, PRINCIPAL_INVESTIGATOR, Dartmouth-Hitcock Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-16
Study Completion Date2026-04-01

Study Record Updates

Study Start Date2024-04-16
Study Completion Date2026-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer