Exercise for Breast Cancer

Recruiting at 1 trial location

Overseen By Christina M Dieli-Conwright, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Investigational agents

Disqualifiers: Uncontrolled illness, Active malignancies, Metastatic disease, others

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

Compensation: Varies

Number of Visits: 7

Duration: 16 weeks

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to determine whether a 16-week exercise program for individuals with breast cancer and have completed treatment (i.e., surgery, chemotherapy, or radiation) for breast cancer will decrease inflammation in fat tissue.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you can continue using adjuvant endocrine therapy, trastuzumab, or pertuzumab if you will be on them for the duration of the study.

What data supports the effectiveness of the treatment CARE, CARE+COACH, Home-Based Stretching, Home-Based Stretching Program, Home-Based Exercise Program, Stretching Therapy for breast cancer?

Research suggests that home-based exercise programs can be beneficial for breast cancer survivors, helping them stick to their exercise routines and improve their long-term health. Additionally, physical activity, including stretching and exercise, has been shown to enhance quality of life and emotional well-being in cancer survivors. ^{1 2 3 4 5}

Is the exercise program safe for participants?

Research suggests that home-based exercise programs are generally safe and beneficial for health, including for cancer survivors and older adults, as they can improve physical functioning and quality of life. ^{3 6 7 8 9}

How is the CARE home-based exercise treatment for breast cancer unique?

The CARE home-based exercise treatment is unique because it allows breast cancer survivors to perform exercises at home, which can improve long-term compliance and health benefits. This approach is particularly beneficial for enhancing shoulder mobility and quality of life after surgery, offering a flexible and accessible alternative to traditional in-person therapy sessions. ^{1 2 10 11 12}

Research Team

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for women over 18 with breast cancer who've finished treatment, are in remission, and meet specific health criteria like a BMI >30. They must not have other uncontrolled illnesses or be on certain treatments. Participants should exercise less than 60 minutes per week and agree to use contraception.

Inclusion Criteria

I have had surgery to remove a breast lump or the entire breast.

I do not have chronic diseases like uncontrolled diabetes, high blood pressure, or thyroid issues.

My breast cancer is in remission with no signs of disease.

Exclusion Criteria

You are currently a smoker.

I am not currently on any experimental treatments or other cancer therapies.

You do not have excessive fat around your waist.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 16-week exercise program involving either circuit-style or traditional aerobic and resistance exercises

16 weeks

7 testing visits, 48 exercise training visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 months

Treatment Details

Interventions

• CARE
• Home-Based Stretching

Trial Overview The study tests if a 16-week exercise program can reduce inflammation in fat tissue of breast cancer survivors. It involves TARE (Targeted Radiotherapy), Home-Based Stretching, and CARE (Comprehensive Assessment and Response Evaluation).

Participant Groups

Group I: Traditional Aerobic Resistance Exercise (TARE) Experimental Treatment 1 Intervention

This research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months - 16 weeks of traditional aerobic and resistance exercise

Group II: Circuit-style aerobic and resistance Exercise(CARE) Experimental Treatment 1 Intervention

This research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months. -16 weeks of circuit-style aerobic and resistance exercise

Group III: Home-Based Stretching Active Control 1 Intervention

Attention Control for 16 weeks home-based stretching -structured home-based stretching program, participants will be asked to maintain their current activity level for the 4-month study duration, and will be offered the CARE program upon study completion

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A home-based exercise program for breast cancer survivors significantly improved upper body strength and shoulder range of motion after 16 weeks, involving 89 women aged around 55 years.

However, the intervention did not lead to significant changes in overall physical fitness, sedentary behavior, or disability measures, suggesting that additional strategies may be needed to enhance broader health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Home-Based Exercise Intervention in the Fitness Profile of Hispanic Survivors of Breast Cancer. Ortiz, A., Hughes, DC., Mama, SK., et al.[2022]

A creative therapeutic exercise program, including supervised group dance sessions, has been integrated into the preoperative and postoperative care for breast cancer patients since 1982, emphasizing the importance of physical therapy in their recovery.

This approach not only addresses the physical rehabilitation needs but also supports emotional well-being, helping patients adjust to changes in body image and fostering a positive attitude through shared experiences in a supportive group setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy and dance in the surgical management of breast cancer. A clinical report. Molinaro, J., Kleinfeld, M., Lebed, S.[2019]

A systematic review of 58 publications identified 34 exercise programs for cancer survivors conducted in home or community settings, highlighting the diversity of interventions available.

The review revealed significant gaps in reporting on the implementation processes and contextual factors affecting these programs, indicating a need for more detailed studies to enhance future community-based exercise interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors: A Scoping Review of Program Characteristics Using the Consolidated Framework for Implementation Research. Neil-Sztramko, SE., Smith-Turchyn, J., Fong, A., et al.[2022]

A study involving 50 patients undergoing preoperative treatment for pancreatic cancer found that social support and neighborhood walkability positively influenced their physical activity levels during treatment.

Patients reported that encouragement from healthcare providers and their motivation to complete treatment were key factors in adhering to home-based exercise prescriptions, highlighting the importance of interpersonal and environmental support in exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supports and Barriers to Home-Based Physical Activity During Preoperative Treatment of Pancreatic Cancer: A Mixed-Methods Study. Parker, NH., Lee, RE., O'Connor, DP., et al.[2023]

A randomized controlled trial involving 76 breast cancer survivors tested a 12-week telephone-based physical activity intervention delivered by trained volunteers, but the intervention did not show significant effects on physical health, mental health, or quality of life outcomes.

The study found that factors such as age, chemotherapy use, and baseline health status significantly influenced how effective the physical activity intervention was, suggesting that these variables should be considered when designing future programs for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer mentorship to promote physical activity among cancer survivors: effects on quality of life. Pinto, B., Stein, K., Dunsiger, S.[2022]

The Strong for Life exercise program was successfully implemented with 105 frail, homebound older adults, showing high satisfaction rates of 100% among volunteers and 98.6% among participants after 4 months.

Participants engaged in exercise an average of 2.2 times per week, with over half exercising 2 to 4 times weekly, leading to significant improvements in social functioning without any serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of implementing the Strong for Life program in community settings. Etkin, CD., Prohaska, TR., Harris, BA., et al.[2019]

A 5-year study involving 2500 adult cancer survivors in Alberta, Canada, is evaluating the effectiveness of a community-based exercise program designed to improve physical functioning and quality of life after cancer treatment.

Participants will engage in mild-to-moderate intensity exercise for 12 weeks, with the primary goal of having at least 150 minutes of exercise per week at the 1-year follow-up, aiming to provide insights into the long-term benefits of exercise on cancer recurrence and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based exercise for health promotion and secondary cancer prevention in Canada: protocol for a hybrid effectiveness-implementation study. McNeely, ML., Sellar, C., Williamson, T., et al.[2023]

A review of 229 articles revealed that 'home-based exercise' can refer to a variety of settings, including at-home, outdoors, or in community facilities, highlighting the need for clearer definitions in research.

Support for home-based exercise interventions varies widely, with elements such as supervision, printed materials, equipment, and technology being used, suggesting that tailored approaches may enhance the effectiveness of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability and limitations in home-based exercise program descriptions in oncology: a scoping review. Lopez, C., McGarragle, K., Pritlove, C., et al.[2020]

Home-based exercise programs for older adults can significantly reduce the fear of falling, providing moderately certain evidence of their effectiveness based on a systematic review of 11 studies involving 1004 participants.

These programs also show potential for improving psychosocial outcomes, such as mental health and quality of life, as well as mobility, although the evidence for these benefits is less certain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Indoor Physical Activity Programs for Community-Dwelling Older Adults: A Systematic Review. Santos, IKD., Cobucci, RN., Medeiros, JA., et al.[2023]

Technology-assisted interventions, such as telephone and mobile applications, have been effective in improving physical activity and overall health in breast cancer patients, with a majority of participants expressing satisfaction with these methods.

During the Covid-19 pandemic, virtual communication became crucial for supporting breast cancer patients, enhancing their treatment adherence and mental well-being despite challenges posed by the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation and Monitoring Physical Activity in Patient with Breast Cancer: Systematic Review. Keikha, L., Maserat, E., Mohammadzadeh, Z.[2022]

Mobilization stretches and exercises after breast cancer surgery effectively improve shoulder range of motion and reduce chest tightness and pain, enhancing the quality of life for patients.

Nurses play a crucial role in encouraging and teaching postoperative exercise to breast cancer patients to help minimize the side effects of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for the Patient after Breast Cancer Surgery. Wilson, DJ.[2018]

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]

References

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

Effectiveness of a Home-Based Exercise Intervention in the Fitness Profile of Hispanic Survivors of Breast Cancer. [2022]

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

Physical therapy and dance in the surgical management of breast cancer. A clinical report. [2019]

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

Community-Based Exercise Programs for Cancer Survivors: A Scoping Review of Program Characteristics Using the Consolidated Framework for Implementation Research. [2022]

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

Supports and Barriers to Home-Based Physical Activity During Preoperative Treatment of Pancreatic Cancer: A Mixed-Methods Study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Peer mentorship to promote physical activity among cancer survivors: effects on quality of life. [2022]

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

Feasibility of implementing the Strong for Life program in community settings. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Community-based exercise for health promotion and secondary cancer prevention in Canada: protocol for a hybrid effectiveness-implementation study. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Variability and limitations in home-based exercise program descriptions in oncology: a scoping review. [2020]

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

Home-Based Indoor Physical Activity Programs for Community-Dwelling Older Adults: A Systematic Review. [2023]

10. India pubmed.ncbi.nlm.nih.gov

Telerehabilitation and Monitoring Physical Activity in Patient with Breast Cancer: Systematic Review. [2022]

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

Exercise for the Patient after Breast Cancer Surgery. [2018]

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

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