55 Participants NeededMy employer runs this trial

Physical Activity Intervention for Breast Cancer Survivors

AM
CJ
Overseen ByCourtney J Stevens, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different exercise plans might help breast cancer survivors become more active. The study aims to determine if a "step-up" intervention, which includes extra support sessions, encourages those who aren't getting enough exercise to become more active and stay engaged. Researchers will divide participants into groups, following either an effort-based or an affect-based exercise prescription. Ideal candidates are breast cancer survivors who have not been very active recently and wish to increase their physical activity to improve their health. Participants need a smartphone and internet access to engage in study activities. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance exercise interventions for breast cancer survivors.

What prior data suggests that this physical activity intervention is safe for breast cancer survivors?

Research has shown that the exercise plans tested in this trial are generally safe for breast cancer survivors. Specifically, the Affect-based Exercise Prescription (Affect-Rx) was studied and found safe for those with stage II or higher breast cancer, with no harmful effects reported. This plan aims to boost mood during exercise, making it more enjoyable and easier to maintain.

Similarly, the Effort-based Exercise Prescription is also safe and beneficial. Studies indicate that this approach, which focuses on perceived exertion during exercise, helps manage cancer-related pain and improves quality of life. These findings suggest that the exercises are not only safe but also offer significant health benefits.

Overall, both types of exercise plans are well-tolerated and present no known safety risks, making them a good option for breast cancer survivors seeking to be more active.12345

Why are researchers excited about this trial?

Researchers are excited about these exercise prescriptions for breast cancer survivors because they take a tailored approach to physical activity. Unlike standard exercise programs, the Affect-based Exercise Prescription focuses on how the activity makes participants feel, potentially improving adherence and enjoyment. Meanwhile, the Effort-based Exercise Prescription uses perceived exertion levels to customize workouts, which might help survivors manage fatigue and gradually increase their fitness. These innovative methods aim to enhance the physical and emotional well-being of breast cancer survivors, offering a more personalized and effective approach than traditional exercise programs.

What evidence suggests that this trial's treatments could be effective for breast cancer survivors?

This trial will compare different exercise prescriptions for breast cancer survivors. Studies have shown that exercise can greatly improve their health. Research indicates that regular physical activity enhances movement, increases muscle strength, and boosts overall physical ability. One study found that low to moderate intensity exercise three times a week reduced tiredness in survivors. Another study found that exercise plans tailored to personal needs, such as those based on individual effort or feelings, can improve quality of life. Additionally, exercise has been linked to better heart health and can even lower the risk of death in breast cancer survivors. Overall, these findings support the idea that exercise can significantly enhance life after breast cancer treatment. Participants in this trial will be assigned to different exercise prescriptions, such as Affect-based or Effort-based Exercise Prescriptions, to evaluate their effectiveness.678910

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who are interested in increasing their physical activity. Participants must be able to join remote exercise sessions and wear an activity monitor. Specific inclusion or exclusion criteria were not detailed.

Inclusion Criteria

I finished my main breast cancer treatment within the last 5 years.
<60 mins/week moderate-vigorous physical activity (MVPA) with no major changes for the past 6 months
I have a smartphone or tablet and am willing to use it for study surveys.
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Exclusion Criteria

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

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessment and are assigned to either Affect-based or Effort-based exercise prescription

1 week
1 visit (in-person)

Initial Intervention

Participants participate in three meetings with the interventionist to increase weekly exercise

6 weeks
3 visits (virtual)

Step-up Intervention

Participants performing <150 minutes of MVPA at 6 weeks are randomized to continue standard or step-up intervention

6 weeks
3 additional visits (virtual) for step-up group

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
4 data collection points (Baseline, 2 weeks, 6 weeks, 12 weeks)

What Are the Treatments Tested in This Trial?

Interventions

  • Affect-based Exercise Prescription
  • Effort-based Exercise Prescription
  • Standard Exercise Promotion Program
  • Step-up Exercise Promotion Program

Trial Overview

The study compares different ways of encouraging exercise: affect-based, effort-based, standard promotion, and a 'step-up' program for those less active at week 6. All programs are delivered remotely with support from an exercise specialist.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: Affect-based Exercise Prescription (Affect-Rx) Step-UpExperimental Treatment3 Interventions
Group II: Affect-based Exercise Prescription (Affect-Rx) StandardExperimental Treatment2 Interventions
Group III: Effort-based Exercise Prescription (RPE-Rx) StandardActive Control1 Intervention
Group IV: Effort-based Exercise Prescription (RPE-Rx) Step-UpActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials
548
Recruited
2,545,000+

Citations

Exercise effects on fatigue in breast cancer survivors after ...

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Exercise Promotion for Breast Cancer Survivors

Research shows that the exercise plans tested in this trial are generally safe for breast cancer survivors. Studies have not found any harmful effects from the ...

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An Affect-based exercise prescription (Affect-Rx) may be a viable strategy for supporting this effort. Aims. Guided by the ORBIT Model for ...

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During active treatment, combined exercise significantly improved muscular strength, FEC, and cardiorespiratory fitness, but not fat-free mass.

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The goal of this clinical trial is to test the effect of an affect-based exercise prescription on moderate-vigorous physical activity participation among ...