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

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 (Study 2)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "These meetings are the same for all participants. * Be asked to wear an activity monitor and respond to brief surveys for 10 straight days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares exercise plans based on how exercise makes people feel with plans based on how hard they work. It is for breast cancer survivors who finished their main treatment within the past 5 years and do little exercise. Over 12 weeks, the study will check exercise levels, satisfaction, and how many people stay in the study.

The goal of this clinical trial is to test the effect of an affect-based exercise prescription on moderate-vigorous physical activity participation among survivors of breast cancer who completed primary treatment within the last 5 years. The main questions it aims to answer are: 1. Do at least 50% of participants assigned to the affect-based exercise prescription engage in ≥90 minutes of moderate-vigorous physical activity by the end of 12-weeks follow-up? 2. What level of satisfaction do breast cancer survivors who receive the affect-based exercise prescription report relative to breast cancer survivors who receive an effort-based exercise prescription. 3. What proportion of participants assigned to the affect-based exercise prescription stay enrolled in the study relative to the number of participants who stay enrolled in the effort-based exercise prescription. All participants will: * Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription. * Participate in two meetings with a member of the study team meant to help them get started increasing weekly exercise. These meetings are the same for all participants. * Be asked to wear an activity monitor and respond to brief surveys for 10 straight days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have finished main treatment for stage 0–III breast cancer within the past 5 years. Main treatment includes surgery, chemotherapy, and radiation.
  • Do less than 60 minutes a week of exercise that makes you breathe harder, with no major changes in the past 6 months.
  • Own an Android or iPhone smartphone or tablet and be willing to answer surveys through an app.
  • Be willing to wear an ActiGraph activity monitor during study check-in periods.
  • Have internet access to complete online surveys.

Who can't join

  • Cannot speak or read English.
  • Have a health reason that makes exercise unsafe, based on an exercise safety questionnaire.
  • Are pregnant.
  • Have a history of severe mental illness or currently take mood-stabilizing medicines, such as antipsychotics, anticonvulsants, or lithium.
  • Have moderate to severe signs of depression, shown by a score of 10 or higher on the PHQ-8 questionnaire.
  • Have moderate to severe problems with memory or thinking, shown by a score below 3 on a 6-question test.
  • Have signs of a significant alcohol or drug use problem, shown by a score of 2 or higher on the CAGE-AID questionnaire.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * ≥18 years old * Within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for Stage 0-III breast cancer * \<60 mins/week moderate-vigorous physical activity (MVPA) with no major changes for the past 6- months * Own an Android or iPhone smartphone (or tablet) and willing to use it 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 the 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.

Study sites (1)

NH