Exercise Program for Breast Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Thomas Jefferson University

Disqualifiers: Severe cardiopulmonary, Metabolic, Renal, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates the impact of a tailored physical activity program on physical activity in patients with breast cancer that has spread from where it first started to other places in the body (metastatic). It has been shown that decreased physical activity contributes to poor performance and quality of life. Evidence has also shown that exercise could improve physical fitness, physical functioning, quality of life, and cancer-related fatigue, however, there is concern that it may not be available to those with physical limitations. The proposed physical activity program offers a comprehensive and individualized assessment for each metastatic breast cancer patient and includes a high quality, tailored exercise home-based program designed by an advanced qualified cancer exercise specialist. A tailored physical activity program may improve physical activity in metastatic breast cancer patients.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your healthcare provider for guidance.

What data supports the idea that Exercise Program for Breast Cancer is an effective treatment?

The available research shows that exercise programs, including aerobic and resistance training, can improve the quality of life for breast cancer patients and survivors. Studies indicate that these exercise programs help reduce fatigue, enhance physical performance, and improve overall well-being during and after treatment. For example, one study found that a 12-week exercise program increased muscular strength and improved quality of life in breast cancer survivors. Another study highlighted that exercise during chemotherapy helped maintain physical functioning and psychosocial health. These findings suggest that exercise is a beneficial treatment for managing the side effects of breast cancer. ^{1 2 3 4 5}

What safety data exists for exercise programs in breast cancer treatment?

Exercise programs, including aerobic and resistance training, have been shown to be safe for breast cancer survivors. Studies indicate that physical activity can be performed safely during and after treatment, with benefits such as improved fitness, strength, and quality of life. Although more research is needed, the American Cancer Society and American College of Sports Medicine recommend regular moderate-intensity exercise for most breast cancer survivors. ^{5 6 7 8 9}

Is the Exercise Intervention a promising treatment for breast cancer?

Yes, the Exercise Intervention is a promising treatment for breast cancer. It can improve physical and mental health, boost energy, and enhance quality of life for breast cancer survivors. Exercise programs can be enjoyable and social, helping patients feel better during and after treatment. ^{7 10 11 12 13}

Research Team

Eligibility Criteria

This trial is for individuals with metastatic breast cancer who are looking to improve their physical activity and quality of life. The program is tailored, considering individual limitations, and designed by a specialist to be done at home.

Inclusion Criteria

Insufficiently inactive defined as answering 'no' to screening question 'On average, do you engage in at least 75 minutes a week of vigorous activity (like jogging) or at least 150 minutes a week of moderate activity (like a brisk walk)?'

I am able to get out of my bed or chair and move around.

Able to read and speak English

Exclusion Criteria

Any condition that may limit the ability to comply with behavioral and physical recommendations of the virtual exercise program

Pregnancy

I need help or a device to walk safely.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Assessment

Participants undergo a 30-minute assessment with the instructor to review health history, concerns, and limitations

1 week

1 visit (virtual)

Treatment

Participants engage in a 6-week tailored physical activity program with weekly live virtual exercise sessions

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for changes in physical activity, physical function, and quality of life

6 weeks

Treatment Details

Interventions

• Exercise Intervention (Behavioural Intervention)

Trial Overview The study tests a personalized home-based exercise program developed by cancer exercise specialists. It aims to see if this intervention can boost physical fitness, functioning, quality of life, and reduce fatigue in metastatic breast cancer patients.

Participant Groups

Group I: Supportive care (virtual exercise sessions) Experimental Treatment 5 Interventions

The 2Unstoppable Strong program is 6 weeks with a weekly live via Zoom but also recorded exercise class. All participants will complete a phone screening (with 2Unstoppable) to determine eligibility and interest; a 30-minute assessment with the instructor over Zoom or FaceTime to review health history, concerns, \& limitations; then provide a signed Physician Release, a signed liability waiver and a completed health questionnaire.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Thomas Jefferson University Hospital Philadelphia, PA

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Patients Recruited

189,000+

References

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

Effects of aerobic and resistance exercise in breast cancer patients receiving adjuvant chemotherapy: a multicenter randomized controlled trial. [2022] Breast cancer chemotherapy may cause unfavorable changes in physical functioning, body composition, psychosocial functioning, and quality of life (QOL). We evaluated the relative merits of aerobic and resistance exercise in blunting these effects.

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

Bootcamp during neoadjuvant chemotherapy for breast cancer: a randomized pilot trial. [2021] Exercise may improve cancer outcomes. Neoadjuvant chemotherapy (NC) for breast cancer provides a unique setting to evaluate intervention effects. Treatments leading to decreased post-neoadjuvant Ki-67 levels, smaller tumor size, and higher pathologic response are associated with improved survival and lower recurrence. This randomized, prospective pilot trial evaluates the feasibility of supervised exercise during NC for breast cancer.

3. Canada pubmed.ncbi.nlm.nih.gov

Effects of exercise on breast cancer patients and survivors: a systematic review and meta-analysis. [2022] Physical exercise has been identified as a potential intervention to improve quality of life in women with breast cancer. We sought to summarize the available evidence concerning the effects of exercise on breast cancer patients and survivors.

4. Germany pubmed.ncbi.nlm.nih.gov

The effect of training interventions on physical performance, quality of life, and fatigue in patients receiving breast cancer treatment: a systematic review. [2019] The primary purpose of this systematic review is to structure the available evidence concerning physical exercise programs and their effects on (1) physical performance outcomes, (2) experienced fatigue, and (3) quality of life (QoL) in patients during the initial treatment for breast cancer.

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

Effects of a 12-week resistance and aerobic exercise program on muscular strength and quality of life in breast cancer survivors: Study protocol for the EFICAN randomized controlled trial. [2023] The number of people living with the side effects of breast cancer treatment (eg, loss of muscular mass and muscular strength, upper-limb mobility and disability, lymphedema, cardiac toxicity, and reduced quality of life) is increasing yearly. These consequences can be improved through exercise, specially combining resistance and aerobic training. Previous exercise trials have not been consistent in applying training principles and standardized reporting, and this partly explains the variability in obtained results. The aim of this study is to assess the effect of a 12-week supervised resistance exercise program combined with home-based aerobic exercise, compared with home-based aerobic exercise only, on muscular strength and several aspects of health-related quality of life in breast cancer survivors. To maximize transparency, replicability, and clinical applicability, the intervention is described following the consensus on exercise reporting template.

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

Clinically Relevant Physical Benefits of Exercise Interventions in Breast Cancer Survivors. [2018] Evidence is currently limited for the effect of exercise on breast cancer clinical outcomes. However, several of the reported physical benefits of exercise, including peak oxygen consumption, functional capacity, muscle strength and lean mass, cardiovascular risk factors, and bone health, have established associations with disability, cardiovascular disease risk, morbidity, and mortality. This review will summarize the clinically relevant physical benefits of exercise interventions in breast cancer survivors and discuss recommendations for achieving these benefits. It will also describe potential differences in intervention delivery that may impact outcomes and, lastly, describe current physical activity guidelines for cancer survivors.

7. Switzerland pubmed.ncbi.nlm.nih.gov

Design and implementation of a community-based exercise program for breast cancer patients. [2022] Research has indicated that exercise is critical in the recovery process for breast cancer patients, and yet this evidence has infrequently been translated into sustainable community programming. The present article describes the processes and operations of beauty (the Breast Cancer Patients Engaging in Activity and Undergoing Treatment program). This evidence-based 12-week exercise program, with an optional 12-week maintenance component, is supported by the Wings of Hope Foundation, allowing the program to be delivered at no cost to participants. The program was designed to restore and improve the physical well-being of women living with breast cancer as they undergo chemotherapy or radiation treatments. Evaluations measure safety and adherence to the program and the effects of the program on physiologic and psychological outcomes and quality of life. The beauty program addresses the gap between the level of evidence for the benefits of exercise after a cancer diagnosis and translation of that evidence into community programming by providing an accessible, individualized, and safe physical activity program for women during treatment for breast cancer.

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

Role of adjuvant and posttreatment exercise programs in breast health. [2019] Growing evidence suggests that physical activity may be an important part of survivorship care for women with a history of breast cancer. Observational evidence suggests that women who are physically active after breast cancer diagnosis have a 30% to 50% lower risk of breast cancer recurrence, breast cancer death, and overall death compared with sedentary individuals. Although randomized controlled trials have not been performed to test the ability of exercise to improve outcomes in women with early-stage breast cancer, many small intervention studies have shown the safety and potential benefits of exercise in the adjuvant and posttreatment settings. These studies have shown that physical activity can be performed safely both during and after adjuvant treatment for breast cancer, and that women who increase physical activity in these settings experience improvements in fitness, strength, quality of life, and other end points. Although more research is needed to fully define the role of exercise in breast cancer survivors, the many proven benefits of physical activity have led the American Cancer Society and American College of Sports Medicine to encourage regular participation in moderate-intensity recreational activity for most breast cancer survivors. This article reviews the growing evidence that exercise could be an important part of breast cancer survivorship, and describes current exercise guidelines for breast cancer survivors.

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

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. [2019] To review current data regarding physical activity and breast cancer including cancer risk, cancer prognosis, treatment-related side effects, and patient-reported outcomes. We will summarize current physical activity guidelines for cancer survivors and discuss opportunities to study and implement physical activity programs in cancer survivors.

10. England pubmed.ncbi.nlm.nih.gov

Exercise for breast cancer survivors: research evidence and clinical guidelines. [2010] Exercise can have significant benefits for breast cancer survivors during and after treatment. The general aerobic prescription is for moderate-intensity activity (50% to 75% heart rate reserve), 3 to 5 days per week, 20 to 60 minutes per session. Resistance training should also be incorporated into the programs. Psychological health is optimized by exercise that is enjoyable, develops new skills, incorporates social interaction, and takes place in a mind- and spirit-stimulating environment. Conditions that warrant prescription modification include fatigue and nausea, cytopenias, lymphedema, and bone metastasis. Postcancer exercise is facilitated by instilling a positive attitude toward exercise, confidence in overcoming barriers, and a supportive social environment.

11. England pubmed.ncbi.nlm.nih.gov

Effectiveness of physical exercise on the cardiovascular system in breast cancer patients: a systematic review and meta-analysis of randomized controlled trials. [2021] The primary purpose of this study is to structure the available evidence relating to physical exercise programs and their impact on patients' cardiovascular system during the convalescence for breast cancer.

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

Maximizing exercise in breast cancer survivors. [2009] Regular physical exercise can maximize physical, mental, and social well-being during and after treatment in breast cancer survivors. An exercise program following cancer therapy is facilitated by instilling a positive attitude toward exercise, confidence in conquering barriers, and a supportive social environment. The purpose of this article is to describe the benefits of moderate exercise in breast cancer survivors and propose a comprehensive approach for the cancer care team in maximizing survivor efforts to improve their physical strength and endurance after completion of adjuvant therapy for breast cancer (surgery, chemotherapy, and/or radiation). A moderate exercise program can help most survivors become more physically and mentally fit and energetic. Understanding factors that prompt the initiation of healthy lifestyle choices among breast cancer survivors is critical to encouraging an attitude of healthy living.

13. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of concurrent aerobic and strength training on breast cancer survivors: a pilot study. [2018] The aim of the study was to evaluate the effects of a combined aerobic and strength program on physiological and psychological parameters in female breast cancer survivors.