85 Participants Needed

Exercise Promotion for Breast Cancer Survivors

CJ
HR
Overseen ByHollin R Hakimian, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dartmouth-Hitchcock Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking mood stabilizing medications like antipsychotics, anticonvulsants, or lithium, you may not be eligible to participate.

What data supports the effectiveness of the treatment Core Exercise Promotion Intervention for breast cancer survivors?

Research shows that physical activity provides numerous health benefits for cancer survivors, improving both patient-reported outcomes and physiological health during and after cancer therapy. Additionally, a motivational program for women after breast cancer has been shown to increase physical activity levels 12 months post-rehabilitation.12345

Is the exercise promotion intervention safe for breast cancer survivors?

The ACTIVATE Trial, which used wearable technology to encourage physical activity in breast cancer survivors, did not report any safety concerns, suggesting that the intervention is generally safe for this group.678910

How does the Core Exercise Promotion Intervention treatment differ from other treatments for breast cancer survivors?

The Core Exercise Promotion Intervention is unique because it focuses on promoting physical activity among breast cancer survivors, using behavior change techniques to improve exercise adherence and health outcomes. Unlike standard treatments that may focus on medication or surgery, this intervention aims to enhance physical activity through structured programs and support, potentially improving overall well-being and reducing fatigue.2461112

What is the purpose of this trial?

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.

Research Team

CJ

Courtney Stevens, PhD

Principal Investigator

Dartmouth-Hitcock Health

Eligibility Criteria

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.

Inclusion Criteria

Access to internet to complete REDCap survey assessments
<60 mins/week moderate-vigorous physical activity (MVPA) with no major changes for the past 6 months
I own a smartphone or tablet and agree to use it for surveys.
See 2 more

Exclusion Criteria

Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)
Evidence of moderate-severe cognitive impairment (indicated by a score < 3 on a 6-item cognitive screener)
Non-English speaking/not able to read English
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants are assigned to either the Affect-based or Effort-based exercise prescription and participate in initial meetings to increase weekly exercise

1 week
2 visits (in-person)

Exercise Intervention

Participants follow their assigned exercise prescription and wear an activity monitor, responding to surveys at specified intervals

12 weeks
4 survey points (Baseline, 2 weeks, 6 weeks, 12 weeks)

Follow-up

Participants are monitored for changes in physical activity, depressive symptoms, and other health measures

12 weeks

Treatment Details

Interventions

  • Core Exercise Promotion Intervention
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials
548
Recruited
2,545,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Both breast cancer survivors and healthcare providers agree that exercise counseling is an important part of cancer care, highlighting a shared belief in its benefits.
Over half of the surveyed breast cancer survivors expressed willingness to participate in structured exercise classes, while most providers supported the idea of cancer centers offering such programs, indicating a strong demand for exercise integration in treatment plans.
Attitudes and Beliefs of Older Female Breast Cancer Survivors and Providers About Exercise in Cancer Care.Perry, CK., Ali, W., Solanki, E., et al.[2021]
Breast cancer survivors with Medicaid insurance are less physically active and less likely to recognize the health benefits of exercise compared to those with non-Medicaid insurance, indicating a need for targeted support.
On-treatment and early survivors value health benefits from exercise more than late survivors, suggesting that exercise programs should be tailored to the specific needs and beliefs of survivors based on their treatment status.
Exercise programming and counseling preferences of breast cancer survivors during or after radiation therapy.Karvinen, KH., Raedeke, TD., Arastu, H., et al.[2011]
Physical activity has been shown to significantly improve both patient-reported outcomes and physiological health in cancer survivors during and after treatment, highlighting its importance in recovery.
The review discusses ongoing phase III trials that are investigating the impact of physical activity on clinical disease endpoints, suggesting a strong focus on integrating exercise into cancer care to enhance patient outcomes.
Putting Exercise Into Oncology Practice: State-of-the-Science, Innovation, and Future Directions.Brown, JC., Ligibel, JA.[2023]

References

Attitudes and Beliefs of Older Female Breast Cancer Survivors and Providers About Exercise in Cancer Care. [2021]
Exercise programming and counseling preferences of breast cancer survivors during or after radiation therapy. [2011]
Putting Exercise Into Oncology Practice: State-of-the-Science, Innovation, and Future Directions. [2023]
[A Motivational-Volitional Program for Women after Breast Cancer Increases Physical Activity 12 Months Post Rehabilitation - Results of a Prospective Controlled Trial]. [2022]
A systematic review summarizing the effect of health care provider-delivered physical activity interventions on physical activity behaviour in cancer survivors. [2021]
A randomized controlled trial of a wearable technology-based intervention for increasing moderate to vigorous physical activity and reducing sedentary behavior in breast cancer survivors: The ACTIVATE Trial. [2020]
Breast cancer survivors' physical activity and experiences while transitioning to a virtual cardiovascular rehabilitation program during a pandemic (COVID-19). [2022]
Effects of the ACTIVity And TEchnology (ACTIVATE) intervention on health-related quality of life and fatigue outcomes in breast cancer survivors. [2020]
Exercise levels and preferences on exercise counselling and programming among older cancer survivors: A mixed-methods study. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Study design and methods for the ACTIVity And TEchnology (ACTIVATE) trial. [2019]
Updated systematic review of exercise studies in breast cancer survivors: attention to the principles of exercise training. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Better exercise adherence after treatment for cancer (BEAT Cancer) study: rationale, design, and methods. [2022]
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