Exercise Program for Breast Cancer Survivors

(B-REP Trial)

Overseen By Cancer AnswerLine

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Disqualifiers: Metastatic disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that ongoing hormonal therapy is acceptable, so you may be able to continue some treatments.

What data supports the effectiveness of this treatment for breast cancer survivors?

Research shows that exercise programs can significantly improve the well-being of cancer survivors by reducing side effects like fatigue and depression. Tailored exercise plans, like those used in the study, help breast cancer patients recover better during and after treatment, enhancing their quality of life. ^{1 2 3 4 5}

Is the exercise program for breast cancer survivors safe?

Research shows that exercise programs for breast cancer survivors are generally safe and beneficial. Evaluations of these programs measure safety and adherence, and they are designed to improve physical well-being during treatment, with attention to preventing injuries and ensuring proper training for staff. ^{1 2 6 7 8}

How is the individualized exercise program treatment different from other treatments for breast cancer survivors?

The individualized exercise program is unique because it is tailored specifically to each breast cancer survivor's needs, taking into account their current health status and personal preferences, unlike standard exercise recommendations that are more general. This personalized approach aims to optimize physical and psychological health by incorporating enjoyable activities, skill development, and social interaction, which can be adjusted for conditions like fatigue or lymphedema. ^{1 3 9 10 11}

What is the purpose of this trial?

The study will use a cross-sectional study design with a follow-up 2-arm randomized controlled trial with that has assessments at baseline, post-intervention (i.e., Week 12), and 3-months post-intervention (i.e., Week 24). The 2 arms are the 12-week intervention and a health education control among 60 Black breast cancer survivors.

Research Team

Angela Fong, PhD

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

This trial is for Black or African American women over 18 who've had breast cancer stages 0I to IIIA and finished primary treatment within the last 5 years. They should not be currently meeting exercise guidelines, but can't join if they have metastatic disease, are pregnant, planning surgery, moving out of the US during the study period, or unable to increase exercise safely.

Inclusion Criteria

I am a woman aged 18 or older.

I am a woman who can speak and understand English.

Women who identify as Black or African American or Afro-Latina/e.

Exclusion Criteria

Women with medical reasons that preclude them from increasing current exercise levels

I am a woman planning to have surgery soon.

I am not participating in another exercise study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments conducted before intervention

1 week

Treatment

Participants undergo a 12-week exercise intervention or health education control

12 weeks

Weekly sessions

Post-intervention Assessment

Assessments conducted immediately after the 12-week intervention

1 week

Follow-up

Participants are monitored for outcomes 3 months post-intervention

12 weeks

Treatment Details

Interventions

• Control Arm
• Individualized exercise program

Trial Overview The B-REP study compares a health education control with a personalized 12-week exercise program for Black breast cancer survivors. Participants will be randomly placed in one of these two groups and assessed at the start, after 12 weeks (post-intervention), and after another three months.

Participant Groups

Group I: Intervention (Supervised exercise) Experimental Treatment 1 Intervention

The individualized resistance exercise program is based on participants' baseline 1-repetition maximum muscular strength assessment (i.e., the maximum lifted for 1 repetition) and is aligned with current cancer-specific exercise recommendations. The resistance exercise program will follow the FITT principle (frequency, intensity, time, and type). Sessions will be 35-45 minutes in duration.

Group II: Control Active Control 1 Intervention

Participants randomized to health education control condition will receive the American Cancer Society Physical Activity and the Person with Cancer summary for patients and American College of Sports Medicine Exercise is Medicine Effects of Exercise on Health-Related Outcomes in Those with Cancer infographic

Individualized exercise program is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Individualized exercise program for:

• Breast cancer rehabilitation
• Improvement of quality of life in cancer survivors

Approved in Canada as Individualized exercise program for:

• Breast cancer rehabilitation
• Improvement of quality of life in cancer survivors

Approved in European Union as Individualized exercise program for:

• Breast cancer rehabilitation
• Improvement of quality of life in cancer survivors

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Findings from Research

The ActivOnco model of care, which includes exercise prescription and rehabilitation screening, effectively improves the quality of life for cancer survivors, as demonstrated by assessments of 1635 patients and exercise prescriptions for 1066 participants from 2011 to 2015.

While exercise is beneficial, it is not a complete solution for all functional declines related to cancer and its treatment, highlighting the need for comprehensive support and resources to address the diverse rehabilitation needs of cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation and exercise oncology program: translating research into a model of care. Dalzell, MA., Smirnow, N., Sateren, W., et al.[2019]

The Breast Cancer Patients Engaging in Activity and Undergoing Treatment (BEAUTY) program is a 12-week evidence-based exercise initiative designed to improve the physical and psychological well-being of women undergoing chemotherapy or radiation for breast cancer, offered at no cost to participants.

The program aims to bridge the gap between research on the benefits of exercise for breast cancer recovery and practical community implementation, ensuring safety and adherence while enhancing quality of life for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of a community-based exercise program for breast cancer patients. Leach, HJ., Danyluk, JM., Culos-Reed, SN.[2022]

Tailored exercise classes significantly improved physical fitness and coping mechanisms among 25 breast cancer survivors, helping them overcome barriers to exercise due to altered physical appearance and fitness levels.

Participants valued the peer support from the group, which fostered psychological well-being and a sense of normality, ultimately leading to improved self-esteem and a greater sense of mastery over their cancer experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of breast cancer survivors participating in a tailored exercise intervention -a qualitative study. Luoma, ML., Hakamies-Blomqvist, L., Blomqvist, C., et al.[2015]

Exercise has been shown to provide significant benefits for cancer survivors during and after treatment, yet exercise support is not commonly integrated into cancer care.

To enhance accessibility and effectiveness of exercise programs for cancer patients, combining hospital and community resources with home-based instruction is a proposed solution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in clinical cancer care: a call to action and program development description. Santa Mina, D., Alibhai, SM., Matthew, AG., et al.[2022]

Physical activity and targeted exercise therapy can significantly improve outcomes for cancer patients, helping to manage side effects like fatigue and depression, especially when introduced right after diagnosis.

Moderate endurance training combined with individualized strength training is particularly effective and can be recommended for all cancer patients, regardless of cancer type, while ensuring contraindications are considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity and exercise therapy in oncology]. Zoth, N., Böhlke, L., Theurich, S., et al.[2023]

In a study involving breast cancer survivors at risk for lymphedema, weightlifting showed a higher rate of musculoskeletal injuries compared to standard care, with injury rates of 2.3 per 1,000 bouts for the weightlifting group.

Despite the efficacy of weightlifting as a rehabilitative exercise, 20.9% of participants required medical attention that led to modifications in their exercise regimen, highlighting the need for well-trained health and fitness professionals to safely implement such programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of weightlifting among women with or at risk for breast cancer-related lymphedema: musculoskeletal injuries and health care use in a weightlifting rehabilitation trial. Brown, JC., Troxel, AB., Schmitz, KH.[2021]

Physical activity is linked to a lower risk of developing breast cancer and recurrence, as well as improved survival rates, based on observational studies.

Engaging in physical activity can alleviate treatment-related side effects, such as fatigue from chemotherapy and musculoskeletal issues from aromatase inhibitors, highlighting its importance in breast cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. Peterson, LL., Ligibel, JA.[2019]

The Active Living After Cancer program, designed for breast cancer survivors, effectively improved physical activity levels and quality of life among 127 participants, demonstrating significant enhancements in both mental and physical well-being after 12 weeks of community-based sessions.

Participants showed measurable improvements in physical functioning, with increased sit-to-stand repetitions and longer distances walked in a 6-minute test, indicating that the program successfully promoted better physical capabilities in minority and medically underserved survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Living After Cancer: Adaptation and evaluation of a community-based physical activity program for minority and medically underserved breast cancer survivors. Tami-Maury, IM., Liao, Y., Rangel, ML., et al.[2022]

Exercise significantly benefits breast cancer survivors, with recommendations for moderate-intensity aerobic activity 3 to 5 days a week for 20 to 60 minutes, along with resistance training.

Psychological health improves with enjoyable exercise that includes social interaction and skill development, while modifications may be needed for conditions like fatigue or lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for breast cancer survivors: research evidence and clinical guidelines. Courneya, KS., Mackey, JR., McKenzie, DC.[2010]

The HEALTh program, a customized cardiac rehabilitation model for female breast cancer survivors, significantly improved cardiorespiratory fitness by 14% and enhanced quality of life and reduced depressive symptoms after 22 sessions.

With a program adherence rate of 66.6%, the study involved 152 breast cancer survivors, demonstrating that structured exercise and education can effectively support physical and mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. Dolan, LB., Barry, D., Petrella, T., et al.[2019]

The study involved 63 breast cancer survivors across 66 group exercise counseling sessions, revealing that while a breast cancer diagnosis creates a common bond, factors like age and expectations can hinder group cohesion.

Key barriers to adherence included feelings of risk for cancer recurrence and people-pleasing behavior, highlighting the need for mental health referrals and effective behavioral modification techniques in group settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned in the trenches: facilitating exercise adherence among breast cancer survivors in a group setting. Rogers, LQ., Vicari, S., Courneya, KS.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Rehabilitation and exercise oncology program: translating research into a model of care. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Design and implementation of a community-based exercise program for breast cancer patients. [2022]

3. Greece pubmed.ncbi.nlm.nih.gov

Experiences of breast cancer survivors participating in a tailored exercise intervention -a qualitative study. [2015]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise in clinical cancer care: a call to action and program development description. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Physical activity and exercise therapy in oncology]. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety of weightlifting among women with or at risk for breast cancer-related lymphedema: musculoskeletal injuries and health care use in a weightlifting rehabilitation trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Active Living After Cancer: Adaptation and evaluation of a community-based physical activity program for minority and medically underserved breast cancer survivors. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Exercise for breast cancer survivors: research evidence and clinical guidelines. [2010]

10. United States pubmed.ncbi.nlm.nih.gov

The Cardiac Rehabilitation Model Improves Fitness, Quality of Life, and Depression in Breast Cancer Survivors. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Lessons learned in the trenches: facilitating exercise adherence among breast cancer survivors in a group setting. [2021]