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Clinical Trials/NCT04903249
NCT04903249
Completed
Not Applicable

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

Dartmouth-Hitchcock Medical Center1 site in 1 country37 target enrollmentAugust 10, 2021
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
37
Locations
1
Primary Endpoint
Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 10, 2021
End Date
June 13, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Courtney J. Stevens

Assistant Professor of Psychiatry

Dartmouth-Hitchcock Medical Center

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

Outcomes

Primary Outcomes

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

Time Frame: 12-weeks follow-up assessment

A 4-item self-report questionnaire used to measure acceptability of the affect-regulated exercise prescription using a Likert scale ranging from 0 (not at all) to 4 (very much). Total scores range from 0 - 16. Higher scores indicate greater acceptability.

Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up

Time Frame: 6-weeks follow-up assessment

The number of participants with valid accelerometer data out of the total number of participants in the sample during the 6-week follow-up assessment, multiplied by 100%.

Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion

Time Frame: Baseline through 12-weeks follow-up assessments

The percentage of ecological momentary assessment (EMA) survey prompts completed by participants during the study out of the total number of EMA survey prompts delivered to participants.

Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up

Time Frame: 2-weeks follow-up assessment

The number of participants with valid accelerometer data out of the total number of participants in the sample during the 2-week follow-up assessment, multiplied by 100%.

Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up

Time Frame: 12-weeks follow-up assessment

The number of participants with valid accelerometer data out of the total number of participants in the sample during the 12-week follow-up assessment, multiplied by 100%.

Percentage of Sample With Valid Accelerometer Data at Baseline

Time Frame: Baseline assessment

The number of participants with valid accelerometer data out of the total number of participants in the sample at baseline, multiplied by 100%.

Number of Participants Who Completed the Exit Interview

Time Frame: 12-weeks follow-up assessment

Semi-structured interview to assess participants' perceptions regarding their experience participating in the study.

Secondary Outcomes

  • Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire(12-weeks follow-up assessment)
  • Study Retention at 12-weeks Follow-up(12-weeks follow-up assessment)
  • Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up(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 Sites (1)

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