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Pilot SMART of a Remotely Delivered, Physical Activity Intervention for Breast Cancer Survivors

A Pilot Sequential, Multiple Assignment, Randomized Trial (SMART) of a Remotely Delivered, Physical Activity Intervention for Breast Cancer Survivors

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 consecutive 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 tests an exercise program delivered from a distance for breast cancer survivors who are not very active. It looks at whether adding extra meetings with an exercise specialist helps people who are still below 150 minutes of moderate to hard exercise at week 6. It also checks whether people join and stay in the program.

The goal of this clinical trial is to evaluate the feasibility of randomizing participants to a "step-up" intervention pathway when they perform \<150 minutes of MVPA at the 6-week data collection burst. Participants who performed \<150 minutes of MVPA at the 6-week data collection burst will be randomized to either continue with the standard intervention or advance to the step-up intervention. The main questions it aims to answer are: 1. What percentage of participants who are eligible for the intervention phase enroll in the intervention phase? 2. Will participants assigned to the "step-up" intervention pathway demonstrate equal or greater rates of study retention and intervention engagement relative to those assigned to the standard intervention arm? 3. What percentage of the sample is performing \>150 minutes accelerometer measured MVPA/week at the intervention mid-point (week 6-data collection burst) and end-of-study (week 12-data collection burst)? 4. Do at least 50% of participants assigned to the "step-up" intervention pathway achieve a clinically meaningful volume of weekly MVPA by 12-weeks follow-up? All participants will: * Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription. * Participate in three meetings with the interventionist (an exercise specialist) 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 consecutive days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks. Some participants (those performing \<150 minutes of MVPA at the 6-week data collection burst) will be assigned to the step-up intervention pathway. Participants assigned to the step-up intervention pathway will complete 3 additional follow-up meetings with the interventionist. During these meetings, the interventionist will help participants identify opportunities to be more active, set goals, and problem solve barriers to action.

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 primary treatment for stage 0–III breast cancer within the past 5 years. This includes surgery, chemotherapy, and radiation.
  • Do less than 60 minutes of moderate to hard exercise each week, with no major changes in the past 6 months.
  • Own an Android or iPhone smartphone or a tablet, and be willing to use it for surveys in 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 major health reason that makes exercise unsafe, based on an exercise safety questionnaire.
  • Are currently 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 screening test.
  • Have signs of a significant alcohol or drug use problem, shown by a score of 2 or higher on the CAGE-AID screening test.

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