NCT04903249

A Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation

Completed NA Results posted Last updated 27 July 2023

What this trial tests

NA trial testing Core Exercise Promotion Intervention in Breast Cancer in 37 participants. Completed in 13 June 2022.

Timeline

10 August 2021

Primary endpoint
10 June 2022

13 June 2022

Quick facts

Lead sponsor	Dartmouth-Hitchcock Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	37
Start date	10 August 2021
Primary completion	10 June 2022
Estimated completion	13 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Core Exercise Promotion Intervention

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Affect-regulated Exercise Prescription	3.31	± .53

Percentage of Sample With Valid Accelerometer Data at Baseline Primary · 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%.

Group	Value	95% CI
Affect-regulated Exercise Prescription	33

Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up Primary · 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%.

Group	Value	95% CI
Affect-regulated Exercise Prescription	28

Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up Primary · 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%.

Group	Value	95% CI
Affect-regulated Exercise Prescription	28

Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up Primary · 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%.

Group	Value	95% CI
Affect-regulated Exercise Prescription	28

Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion Primary · 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.

Group	Value	95% CI
Affect-regulated Exercise Prescription	84.83

Number of Participants Who Completed the Exit Interview Primary · 12-weeks follow-up assessment

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

Group	Value	95% CI
Affect-regulated Exercise Prescription	30

Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up Secondary · 12-weeks follow-up assessment

The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.

Group	Value	95% CI
Affect-regulated Exercise Prescription	32.97	± 40.17

Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire Secondary · 12-weeks follow-up assessment

An 8-item self-report questionnaire used to assess participant satisfaction with study participation using a Likert scale ranging from 1 to 4 . Scores are summed and then averaged; total scores range from 1- 4. Higher scores indicate greater satisfaction.

Group	Value	95% CI
Affect-regulated Exercise Prescription	3.33	± .63

Study Retention at 2-weeks Follow-up Secondary · 2-weeks follow-up assessment

Number of participants who complete the 2-week follow-up assessment out of the number of participants who enroll in the study.

Group	Value	95% CI
Affect-regulated Exercise Prescription	30

Study Retention at 6-weeks Follow-up Secondary · 6-weeks follow-up assessment

Number of participants who complete the 6-week follow-up assessment out of the number of participants who enroll in the study.

Group	Value	95% CI
Affect-regulated Exercise Prescription	30

Study Retention at 12-weeks Follow-up Secondary · 12-weeks follow-up assessment

Number of participants who complete the 12-week follow-up assessment out of the number of participants who enroll in the study.

Group	Value	95% CI
Affect-regulated Exercise Prescription	30

Sponsor's own description

The purpose of this study is to refine the use of an affect-regulated exercise prescription for use with survivors of breast cancer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exercise That Feels as Good as Possible: Acceptability of an Affect-Based Exercise Prescription Among Stage 0-III Breast Cancer Survivors.
   Stevens CJ, Bobak CA, Morrissette KJ, Thompson RC, et al · · 2025 · PMID 40736469 · DOI 10.1002/pon.70225