Health Program for Breast Cancer Survivors

Overseen By Ivan [e-mail]

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Chemotherapy, Radiation, Surgery, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial targets breast cancer survivors who have completed treatment at Zuckerberg San Francisco General Hospital. The trial tests a health behavior program called HEART-ACT, a multidisciplinary intervention focusing on physical activity, nutrition, emotional well-being, and cardiovascular health. Participants receive personalized plans and goals, with individual and group sessions over 12 weeks. This trial suits those who have finished cancer treatment and receive care at the hospital, with no planned surgeries or treatments in the near future. As an unphased trial, it offers participants the chance to enhance their overall well-being through a comprehensive health program.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this health behavior intervention is safe for breast cancer survivors?

A previous study found the HEART-ACT program easy for participants to handle. This program includes activities such as exercise, nutrition advice, and emotional support, aiming to improve the overall health of breast cancer survivors. No serious side effects emerged from joining the program, suggesting it is safe to try. Participants in similar programs have found the activities manageable and beneficial for their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HEART-ACT program for breast cancer survivors because it takes a comprehensive and personalized approach to recovery and wellness. Unlike traditional treatments that might focus solely on medical or physical aspects, HEART-ACT integrates physical activity, nutrition, emotional well-being, and cardiovascular health into a single program tailored to each individual. This holistic and individualized method could potentially enhance overall health outcomes and quality of life for survivors by addressing a broad spectrum of needs in a structured yet flexible manner.

What evidence suggests that this health behavior program is effective for breast cancer survivors?

Research shows that health programs focusing on diet, exercise, and emotional wellness benefit breast cancer survivors. Studies using fitness trackers have demonstrated that these programs increase physical activity, aiding in weight management and improving overall health. Evidence also suggests that these programs may lower the risk of heart disease, a common concern for breast cancer survivors. Additionally, programs addressing sleep problems and weight management have yielded positive results for this group. Together, these findings suggest that the HEART-ACT program, which participants in this trial will undergo, could effectively support survivors' health after treatment. ^{1 3 5 6 7}

Who Is on the Research Team?

Alexis Beatty, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors over 18 who can communicate in English, Spanish, or Cantonese. Participants must have been treated with the intent to cure at Zuckerberg San Francisco General Hospital and not be planning further chemotherapy, radiation, or surgery within the next three months.

Inclusion Criteria

Able to consent for self

Receive care at Zuckerberg San Francisco General Hospital

My treatment was aimed at curing my condition.

Exclusion Criteria

You are expected to live for less than 1 year.

I am scheduled for chemotherapy, radiation, or surgery within the next 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week multi-disciplinary health behavior program with individualized assessments and plans

12 weeks

Weekly sessions alternating between group and individual

Follow-up

Participants are monitored for changes in health outcomes at 3, 6, and 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

• HEART-ACT

Trial Overview The HEART-ACT study tests a health behavior intervention for breast cancer survivors. It includes an intake session followed by individual and group sessions focused on exercise and lifestyle changes, concluding with a graduation.

How Is the Trial Designed?

Group I: Health Behavior Program Experimental Treatment 5 Interventions

Each participant will have an individualized assessment with plan and goals set at the program intake visit. Program components will include: Physical Activity, Nutrition, Emotional Well-being, Cardiovascular Risk, Survivorship, and other items individualized to the participant as needed (e.g., tobacco cessation). The 12-week program will alternate between group and individual sessions each week. Individualized plans will be reviewed every two weeks at the participant individual sessions.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Multiple health behavior change (MHBC) interventions can effectively improve healthy eating and physical activity among cancer survivors, particularly when led by nurses or multidisciplinary teams.

Interventions lasting 17 weeks or longer are more likely to result in significant improvements in these behaviors, highlighting the importance of duration in the effectiveness of MHBC programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Healthy Eating and Physical Activity Behaviors: A Systematic Review of Multiple Health Behavior Change Interventions Among Cancer Survivors. Amireault, S., Fong, AJ., Sabiston, CM.[2023]

The BEAT Cancer intervention significantly improved key social cognitive factors such as self-efficacy, goal setting, and perceived barriers to physical activity among 222 post-treatment breast cancer survivors over a 3-month period.

Despite these improvements in social cognitive constructs, the intervention did not lead to significant indirect effects on increasing physical activity levels measured 6 months after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Cognitive Constructs Did Not Mediate the BEAT Cancer Intervention Effects on Objective Physical Activity Behavior Based on Multivariable Path Analysis. Rogers, LQ., Courneya, KS., Anton, PM., et al.[2021]

Breast cancer survivors using a health and wellness coaching app showed significant weight loss and a greater reduction in body mass index compared to those using a self-guided toolkit, indicating the app's effectiveness in promoting healthier lifestyles.

The app users also reported improvements in physical activity and dietary patterns, suggesting that access to live coaching can enhance adherence to wellness plans, although long-term app usage declined after 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Mobile Health Intervention to Improve Wellness Outcomes for Breast Cancer Survivors. Cairo, J., Williams, L., Bray, L., et al.[2022]

Wearable activity trackers (WATs) are viewed positively by postmenopausal breast cancer survivors, as they help increase self-awareness and motivation to be more active, which is crucial for reducing health risks associated with inactivity.

To enhance the effectiveness of WATs, combining their use with behavioral change techniques like specialist counseling, doctor monitoring, and peer support is recommended, ensuring that users feel comfortable and confident with the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative evaluation of breast cancer survivors' acceptance of and preferences for consumer wearable technology activity trackers. Nguyen, NH., Hadgraft, NT., Moore, MM., et al.[2022]

In a study of 1934 breast cancer survivors, the combination of poor cardiovascular health (CVH) and cardiotoxic cancer treatments significantly increased the risk of coronary heart disease (CHD) and death, with joint effects of 75.9% for CHD and 39.5% for death, surpassing the risks associated with each factor independently.

Achieving better cardiovascular health is crucial for breast cancer survivors, as it appears to offer protection against CHD, even for those who have undergone potentially harmful treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary heart disease and mortality following a breast cancer diagnosis. Guo, A., Zhang, KW., Reynolds, K., et al.[2023]

The ACTIVATE Trial demonstrated that using a Garmin Vivofit 2 activity monitor, along with behavioral coaching, significantly increased moderate to vigorous physical activity (MVPA) by an average of 69 minutes per week in breast cancer survivors over a 12-week period.

Participants in the intervention group also experienced a significant reduction in sedentary behavior, with decreases of 37 minutes per day in total sitting time and 42 minutes per day in prolonged sitting bouts, highlighting the effectiveness of wearable technology in promoting a more active lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a wearable technology-based intervention for increasing moderate to vigorous physical activity and reducing sedentary behavior in breast cancer survivors: The ACTIVATE Trial. Lynch, BM., Nguyen, NH., Moore, MM., et al.[2020]

Breast cancer survivors aged over 65 years have a significantly increased risk of developing certain cardiovascular diseases, particularly deep vein thrombosis (HR 1.67) and pericarditis (HR 1.43), compared to cancer-free women, based on a study of 91,473 breast cancer patients and 454,197 controls.

Despite having a lower baseline prevalence of cardiovascular diseases, breast cancer survivors showed persistent increased risks for conditions like arrhythmia and heart failure even more than 5 years after diagnosis, highlighting the need for ongoing cardiovascular monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Cardiovascular Diseases Among Older Breast Cancer Survivors in the United States: A Matched Cohort Study. Matthews, AA., Peacock Hinton, S., Stanway, S., et al.[2023]

A 12-week online walking intervention for cancer survivors significantly improved physical fitness, blood pressure, waist girth, mental health, social functioning, and general health, based on a study involving 91 participants (46 in the intervention group and 45 in the control group).

Despite the overall health improvements, participants reported increased bodily pain, indicating that while physical activity can enhance health outcomes, it may also lead to discomfort that needs to be managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a 12-Week Online Walking Intervention on Health and Quality of Life in Cancer Survivors: A Quasi-Randomized Controlled Trial. Frensham, LJ., Parfitt, G., Dollman, J.[2019]

As breast cancer survival rates improve, there is a growing need to address cardiovascular health, especially for women undergoing potentially heart-damaging treatments.

Research should focus on developing tools to identify cardiac risk factors, effective preventive treatments, and monitoring techniques to detect early signs of heart damage, while promoting lifestyle changes to enhance cardiovascular fitness in all breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention and Treatment of Cardiac Dysfunction in Breast Cancer Survivors. Fabian, C.[2016]

Older breast cancer survivors (n = 1361) do not have a significantly higher risk of cardiovascular disease (CVD) compared to matched women without breast cancer, indicating that breast cancer status alone is not a strong predictor of CVD risk.

The study highlights that preexisting conditions like smoking, diabetes, and hypertension are much stronger predictors of CVD risk, suggesting that managing these comorbidities is crucial for improving long-term health outcomes in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbidities and cardiovascular disease risk in older breast cancer survivors. Haque, R., Prout, M., Geiger, AM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06055803

Heart Health After Cancer Treatment (HEART-ACT) This is a pilot study testing multi-disciplinary health behavior intervention in breast cancer survivors who have been treated at Zuckerberg San Francisco ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06055803

Heart Health After Cancer Treatment (HEART-ACT) This is a pilot study testing multi-disciplinary health behavior intervention in breast cancer survivors who have been treated at Zuckerberg San Francisco ...

3. reporter.nih.gov reporter.nih.gov/search/I_bJWIRR_0Kb3TKRVha0zw/project-details/11128798

The Effects of Treating Insomnia on Behavioral Weight ... Our preliminary data suggest that CBT-I may enhance weight loss outcomes in women with early stage breast cancer (ESBC). Although the complex, inter-related ...

4. withpower.com withpower.com/trial/phase-breast-neoplasms-11-2023-a4b7c

Health Program for Breast Cancer Survivors What data supports the effectiveness of the treatment HEART-ACT for breast cancer survivors? Research shows that interventions using wearable activity trackers ...

5. cancer.gov cancer.gov/clinicaltrials/NCI-2023-07108

Evaluation of a Health Behavior Intervention to Reduce ... This study may help researchers determine the impact of an exercise and health behavior program on heart disease risk in patients with breast cancer.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38760873/

Formative research to adapt a cardiac rehabilitation program ... A 12-week multi-disciplinary program addressing physical activity, nutrition, emotional well-being, cardiovascular risk, survivorship, and other components if ...

7. trial.medpath.com trial.medpath.com/clinical-trial/7efc7396a6eb25df/nct06055803-heart-health-cancer-treatment-breast-cancer

Heart Health After Cancer Treatment (HEART-ACT) - MedPath This is a pilot study testing multi-disciplinary health behavior intervention in breast cancer survivors who have been treated at Zuckerberg San Francisco ...