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Behavioral Intervention

Affect-based Exercise Prescription (Affect-Rx) for Breast Cancer

N/A

Recruiting

Led By Courtney J Stevens, PhD

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6-weeks follow-up, and 12-weeks follow-up.

Awards & highlights

Study Summary

This trial aims to see if a certain type of exercise plan can increase physical activity in breast cancer survivors. They want to know if more than half of those on the new exercise plan will do at least

Who is the study for?

This trial is for breast cancer survivors who finished their primary treatment within the last 5 years. Participants should be interested in increasing physical activity and willing to wear an activity monitor and answer surveys at specified times.Check my eligibility

What is being tested?

The study tests two exercise prescriptions: one based on affect (how exercises make you feel) and another on effort. It measures how much moderate-to-vigorous exercise participants do, their satisfaction with the program, and retention rates over a 12-week period.See study design

What are the potential side effects?

Since this is a behavioral intervention focusing on exercise promotion rather than medication or medical procedures, traditional side effects are not applicable. However, participants may experience general exercise-related discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6-weeks follow-up, and 12-weeks follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6-weeks follow-up, and 12-weeks follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6-weeks follow-up, and 12-weeks follow-up. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up

Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up

Secondary outcome measures

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

Change in Physical Activity Category Completed in the Past Month Measured Using the Stanford Leisure-Time Activity Categorical Item (L-Cat)

Change in Physical Activity using The International Physical Activity Questionnaire (IPAQ)-Short Form

+5 more

Other outcome measures

Change Overtime in Anxiety measured using The PROMIS Anxiety Form

Change Overtime in Cancer-related Fatigue Measured Using the PROMIS Fatigue Short Form 8a

Change Overtime in Depressive Symptoms using The PROMIS Depression Form

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Affect-based Exercise Prescription (Affect-Rx)Experimental Treatment2 Interventions

Group II: Effort-based Exercise Prescription (RPE-Rx)Active Control2 Interventions

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor

524 Previous Clinical Trials

2,540,704 Total Patients Enrolled

28 Trials studying Breast Cancer

2,352,745 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,675 Previous Clinical Trials

40,926,892 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,275 Patients Enrolled for Breast Cancer

Courtney J Stevens, PhDPrincipal InvestigatorDartmouth-Hitcock Health

2 Previous Clinical Trials

67 Total Patients Enrolled

2 Trials studying Breast Cancer

67 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing medical trial?

"The information available on clinicaltrials.gov indicates that patient recruitment is not ongoing for this particular study. The trial was first listed on 2/15/2024 and last updated on 2/6/2024. While participants are not being enrolled currently, it's noteworthy that there are 2629 other trials actively seeking candidates at present."

Answered by AI

What are the main goals being pursued in this research endeavor?

"The primary focus of this examination is to assess the Average Daily Minutes of Moderate-to-Vigorous Physical Activity monitored using the ActiGraph wGT3X-BT Accelerometer at a 2-week Follow-up period. Additional measures include Study Retention at 2 weeks, indicating the proportion of participants who complete their follow-up assessment compared to those initially enrolled. The study will also evaluate the Acceptability of Affect-regulated Exercise Prescription using the Treatment Acceptability and Preferences (TAP) Measure, which involves a self-evaluation questionnaire utilizing a Likert scale from 0 to 4, with higher scores reflecting better acceptability. Furthermore"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized Two-Arm Proof of Concept Study Testing A Novel Approach to Exercise Promotion Based on Affect-regulation

Courtney J. Stevens 2024. "A Randomized Two-Arm Proof of Concept Study Testing A Novel Approach to Exercise Promotion Based on Affect-regulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06258993.