Testing a new way to promote exercise for breast cancer survivors
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)
This study is testing a new exercise program for breast cancer survivors to see if focusing on how they feel while exercising helps them be more active than a traditional program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT06258993 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of an affect-based exercise prescription in increasing moderate-vigorous physical activity among breast cancer survivors who have completed their primary treatment within the last five years. Participants will be randomly assigned to either an affect-based or an effort-based exercise program, and their engagement in physical activity will be monitored over a 12-week period. The study will also assess participant satisfaction and retention rates between the two groups to determine the feasibility of this novel approach to exercise promotion.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have completed primary treatment for Stage 0-III breast cancer within the last five years and currently engage in less than 60 minutes of moderate-vigorous physical activity per week.
Not a fit: Patients who are non-English speaking, currently pregnant, or have severe mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance physical activity levels and overall well-being in breast cancer survivors.
How similar studies have performed: While this specific approach is novel, previous studies have shown that tailored exercise interventions can improve physical activity levels in cancer survivors.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Clinic — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Courtney J Stevens, PhD — Dartmouth-Hitcock Health
- Study coordinator: Courtney J Stevens, PhD
- Email: courtney.j.stevens@dartmouth.edu
- Phone: 6036509643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.