N/A
Completed N=37
A Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation
Source: ClinicalTrials.gov NCT04903249 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure — 3.31 score on a scale
Summary
The purpose of this study is to refine the use of an affect-regulated exercise prescription for use with survivors of breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure |
3.31 | — |
| PRIMARY Percentage of Sample With Valid Accelerometer Data at Baseline |
33 | — |
| PRIMARY Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up |
28 | — |
| PRIMARY Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up |
28 | — |
| PRIMARY Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up |
28 | — |
| PRIMARY Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion |
84.83 | — |
| PRIMARY Number of Participants Who Completed the Exit Interview |
30 | — |
| SECONDARY Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up |
32.97 | — |
| SECONDARY Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire |
3.33 | — |
| SECONDARY Study Retention at 2-weeks Follow-up |
30 | — |
| SECONDARY Study Retention at 6-weeks Follow-up |
30 | — |
| SECONDARY Study Retention at 12-weeks Follow-up |
30 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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 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
Data sourced from ClinicalTrials.gov (NCT04903249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.