Status:
COMPLETED
A Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to refine the use of an affect-regulated exercise prescription for use with survivors of breast cancer.
Eligibility Criteria
Inclusion
- Within 5 years of completing curative treatment (surgery, chemotherapy, and radiation) for stage 0-III breast cancer
- \<60 mins/week moderate-vigorous physical activity with no major changes for the past 6-months
- Own an Android or iPhone smartphone and willing to use the smartphone 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
- 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 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
Key Trial Info
Start Date :
August 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04903249
Start Date
August 10 2021
End Date
June 13 2022
Last Update
July 27 2023
Active Locations (1)
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1
Dartmouth-Hitchcock Clinic
Lebanon, New Hampshire, United States, 03756