Exercise Program for Breast Cancer

(SABC Trial)

Overseen By Kathleen Lyons, ScD, OTR/L

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: MGH Institute of Health Professions

Disqualifiers: Atrial fibrillation, Angina, Hypertension, others

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

Compensation: Varies

Number of Visits: 9

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a group exercise program called Strength After Breast Cancer, designed for women who have completed treatment for Stage I-III breast cancer. The researchers aim to determine if the program can be successfully offered at an outpatient clinic and if it improves physical function. Participants will attend exercise sessions, complete surveys, and provide feedback on their experience. Women who have finished their main cancer treatments and can safely exercise might be a good fit.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance recovery options for future breast cancer survivors.

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

The trial does not specify if you need to stop taking your current medications. However, hormonal therapies and adjuvant targeted therapies are allowed.

What prior data suggests that the Strength After Breast Cancer program is safe?

A previous study found the Strength After Breast Cancer (SABC) program safe for participants. This program, which includes group exercise sessions, improved physical abilities in women who completed breast cancer treatment. The research indicated it did not increase the risk of lymphedema, a swelling caused by lymph fluid buildup, and actually helped prevent or lessen it. Participants also gained better upper body strength. Overall, the evidence suggests the program is well-tolerated and beneficial for those recovering from breast cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Strength After Breast Cancer" program because it offers a personalized and community-driven approach to recovery. Unlike standard care options that often focus on medication and surgery, this program emphasizes physical therapy and group exercise, which can enhance exercise self-efficacy and quality of life while reducing fatigue. By integrating one-on-one evaluations with group sessions, it provides both individualized attention and social support, aiming to empower participants and improve long-term outcomes in a holistic manner.

What evidence suggests that the Strength After Breast Cancer program is effective for improving physical function after breast cancer treatment?

Research has shown that the Strength After Breast Cancer program, which participants in this trial will undergo, can be successfully used in outpatient clinics. This program combines education and gradual exercise to help breast cancer survivors improve their physical abilities. Studies have found that this method works well in everyday settings, helping patients regain strength and improve their quality of life. Participants in similar programs have reported feeling stronger and healthier. This suggests that the program could be helpful for those wanting to rebuild strength after breast cancer treatment. ^{2 5 6 7 8}

Who Is on the Research Team?

Stephen Wechsler, DPT, PhD

Principal Investigator

MGH Institute of Health Professions

Are You a Good Fit for This Trial?

This trial is for women over 18 who have been treated for Stage I-III breast cancer and are done with primary treatments like surgery, chemo, or radiation. Hormonal and targeted therapies are okay.

Inclusion Criteria

I have completed initial treatment for Stage I-III breast cancer.

Exclusion Criteria

I don't have any health issues that prevent me from safely exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 1 month

1 visit (in-person)

Baseline Assessment

Participants complete a baseline survey regarding exercise self-efficacy, physical activity level, quality of life, and fatigue

1 week

1 visit (in-person)

Treatment

Participants attend a 1-on-1 physical therapy evaluation and 4 group exercise sessions

4 weeks

5 visits (in-person)

Follow-up

Participants complete follow-up surveys and interviews to assess program satisfaction and provide feedback

3 months

2 visits (in-person), 1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Strength After Breast Cancer

Trial Overview The study tests a group exercise program called Strength After Breast Cancer in an outpatient clinic to see if it improves physical function post-treatment and how practical it is.

How Is the Trial Designed?

Group I: Strength After Breast Cancer (SABC) Intervention Experimental Treatment 1 Intervention

Participants will undergo study procedures as outlined: * Complete a baseline survey regarding exercise self-efficacy, physical activity level, quality of life, and fatigue * Attend a 1-on-1 physical therapy evaluation and 4 group exercise sessions at MGH Waltham * After completing the 4 exercise sessions, complete follow-up surveys including a program satisfaction survey * At 1-month post-program, complete follow-up surveys and an individual, semi-structured interview with study staff to supply feedback about the program. * At 3-months post-program, complete follow-up surveys

Who Is Running the Clinical Trial?

MGH Institute of Health Professions

Lead Sponsor

Trials

19

Recruited

2,200+

Published Research Related to This Trial

A study of 136 women post-breast cancer treatment found that their cardiorespiratory (CR) fitness, measured by VO2 peak, was significantly lower than healthy age-matched norms, indicating potential long-term impacts of treatment.

Women with breast cancer-related lymphedema (BCRL) exhibited even lower VO2 peak levels compared to those without BCRL, suggesting that rehabilitation programs should specifically address CR fitness to improve health outcomes and survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorespiratory Fitness in Women with and without Lymphedema following Breast Cancer Treatment. Smoot, B., Johnson, M., Duda J, J., 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 STRENGTH trial involving 90 premenopausal breast cancer patients on chemotherapy demonstrated that home-based diet and exercise interventions can help prevent weight gain and preserve lean body mass during treatment.

The combination of a calcium-rich diet, exercise, and a high fruit and vegetable, low-fat diet led to a significant reduction in body fat percentage compared to the control group, highlighting the potential for dietary and exercise strategies to improve body composition in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. Demark-Wahnefried, W., Case, LD., Blackwell, K., et al.[2021]

A 12-week comprehensive health improvement program (CHIP) for 10 breast cancer patients with moderate-to-severe breast or chest-wall pain led to significant improvements in quality of life (QOL) and pain symptoms, measured at 1 and 6 months post-program.

Patients reported better overall QOL compared to historical control subjects, indicating that exercise may be an effective intervention for managing chronic pain and enhancing well-being in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercise in reducing breast and chest-wall pain in patients with breast cancer: a pilot study. Wong, P., Muanza, T., Hijal, T., et al.[2021]

Strength training (ST) significantly improves maximal strength in cancer survivors, with increases ranging from 20% to 50%, demonstrating its effectiveness in countering treatment-related declines in strength.

While ST also enhances physical function by 7% to 38%, improvements in body composition and psychosocial parameters were less consistent, indicating that strength gains are the most reliable benefit across various cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Independent Effects of Strength Training in Cancer Survivors: a Systematic Review. Hanson, ED., Wagoner, CW., Anderson, T., et al.[2018]

A supervised exercise training program (SETP) significantly improved health-related quality of life (HRQoL) and functional capacity in 93 women with early-stage breast cancer undergoing chemotherapy, showing less deterioration in various quality of life domains compared to usual care alone.

Participants in the exercise group experienced notable improvements in physical and cognitive functioning, reduced fatigue, and enhanced strength, indicating that exercise can be an effective complementary therapy during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training Benefits Health-Related Quality of Life and Functional Capacity during Breast Cancer Chemotherapy: An RCT. Antunes, P., Joaquim, A., Sampaio, F., et al.[2023]

In a study of 295 breast cancer survivors, isometric handgrip strength was found to be a weak predictor of 1-repetition maximum (1-RM) bench press strength, indicating that these two measures assess different aspects of muscular strength.

The average isometric handgrip strength overestimated the 1-RM bench press strength by 4.7 kg, suggesting that relying on handgrip strength alone may not accurately reflect upper body strength in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Maximal Bench Press Strength and Isometric Handgrip Strength Among Breast Cancer Survivors. Rogers, BH., Brown, JC., Gater, DR., et al.[2018]

A meta-analysis of 11 randomized controlled trials involving 666 breast cancer patients found that physical exercise significantly improves cardiovascular health by lowering systolic and diastolic blood pressure, triglyceride levels, and body mass index.

Exercise also enhances cardiovascular fitness by increasing peak oxygen uptake and high-density lipoprotein cholesterol levels, suggesting it could be an effective intervention for cardiovascular care in breast cancer recovery.

NCBI (Pubmed)

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. Wang, S., Yang, T., Qiang, W., et al.[2021]

In a pilot study involving breast cancer survivors, a 12-week home-based aerobic exercise program significantly reduced fatigue levels, indicating its effectiveness in managing cancer-related fatigue.

The resistance exercise program improved functional capacity, as shown by a significant increase in the distance walked during a 6-minute test, suggesting it is a viable strategy for enhancing physical function in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise to alleviate fatigue and improve functional capacity among breast cancer survivors. Yuen, HK., Sword, D.[2022]

The Strength after Breast Cancer (SABC) program was successfully implemented in outpatient rehabilitation clinics, with 76% of surveyed clinicians adopting it and 93% continuing to deliver the program, indicating strong sustainability.

The program reached an average of 13 patients per clinic, primarily through referrals from oncology clinics, although barriers such as lack of referrals and competing clinic demands were noted, highlighting areas for improvement in implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Strength after Breast Cancer (SABC) in outpatient rehabilitation clinics: mapping clinician survey data onto key implementation outcomes. Calo, WA., Doerksen, SE., Spanos, K., et al.[2022]

Exercise interventions during and after chemotherapy for patients with hematological cancer are generally reported as safe and feasible, based on a systematic review of 12 studies, including six randomized controlled trials.

Despite the positive claims about safety and feasibility, many studies lack detailed information on how these conclusions were reached, highlighting the need for more comprehensive reporting in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. Großek, A., Großek, K., Bloch, W.[2023]

Resistance training (RT) is safe for breast cancer survivors (BCS) and does not increase the risk of lymphedema, based on an analysis of ten studies published between 2000 and 2016.

RT effectively improves muscle strength in BCS, particularly when using high loads, although changes in body mass composition were minimal, indicating the need for careful manipulation of training variables for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Effects of Resistance Training in Breast Cancer Survivors. Dos Santos, WDN., Gentil, P., de Moraes, RF., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32885221/

Implementing Strength after Breast Cancer (SABC) in ... Our findings suggest that the online training was sufficient to successfully implement the SABC program in outpatient rehabilitation clinics ...

2. implementationsciencecomms.biomedcentral.com implementationsciencecomms.biomedcentral.com/articles/10.1186/s43058-020-00060-2

Implementing Strength after Breast Cancer (SABC) in ... Our findings suggest that the online training was sufficient to successfully implement the SABC program in outpatient rehabilitation clinics.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06052488

Study Details | NCT06052488 | Strength After Breast Cancer The goal of this study is to explore whether a group exercise program called Strength After Breast Cancer can be delivered in an outpatient physical therapy ...

4. breastcancer.org breastcancer.org/research-news/exercise-program-successful-in-life

Strength After Breast Cancer Exercise Program Successful ... A study has found that the Strength After Breast Cancer program, an education and gradual exercise program, can be successfully implemented in a larger, real- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4411538/

A Hybrid Effectiveness-Implementation Trial of an Evidence ... This trial successfully demonstrated that a physical therapy led strength training program for breast cancer survivors can be implemented in a community setting ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7427930/

Implementing Strength after Breast Cancer (SABC) in ... In a large randomized controlled trial with 295 breast cancer survivors, PAL led to clinically meaningful improvements in upper body strength ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06052488/strength-after-breast-cancer

Strength After Breast Cancer | Clinical Research Trial Listing The SABC program has previously been found to be safe and led to improvements in physical function among women after treatment for breast cancer ...

8. klosetraining.com klosetraining.com/course/online/strength-abc/

Strength After Breast Cancer This weightlifting intervention decreased lymphedema exacerbations by 50%; decreased the onset of lymphedema by 70% (among women with 5+ nodes removed); ...