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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a pilot study testing multi-disciplinary health behavior intervention in breast cancer survivors who have been treated at Zuckerberg San Francisco General (ZSFG).

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 data supports the effectiveness of the treatment HEART-ACT for breast cancer survivors?

Research shows that interventions using wearable activity trackers and health coaching can help breast cancer survivors increase physical activity and reduce sedentary behavior, which are important for improving overall health and quality of life. Additionally, online walking programs have been shown to improve physical fitness, blood pressure, and mental health in cancer survivors. ^{1 2 3 4 5}

Is the Health Program for Breast Cancer Survivors safe for participants?

The research does not provide specific safety data for the Health Program for Breast Cancer Survivors, but it highlights the importance of monitoring cardiovascular health in breast cancer survivors, especially those receiving treatments that may affect the heart. ^{2 5 6 7 8}

How does this treatment for breast cancer survivors differ from other treatments?

This treatment is unique because it uses wearable technology, like the Garmin Vivofit 2 activity monitor, combined with health coaching to encourage breast cancer survivors to be more active and reduce sitting time, which is different from traditional treatments that may not focus on lifestyle changes. ^{2 3 5 9 10}

Research Team

Alexis Beatty, MD, MAS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Comorbidities and cardiovascular disease risk in older breast cancer survivors. [2022]

2. United States 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. [2020]

3. England 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. [2021]

4. Switzerland 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. [2019]

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

A qualitative evaluation of breast cancer survivors' acceptance of and preferences for consumer wearable technology activity trackers. [2022]

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

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

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

Coronary heart disease and mortality following a breast cancer diagnosis. [2023]

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

Risk of Cardiovascular Diseases Among Older Breast Cancer Survivors in the United States: A Matched Cohort Study. [2023]

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

Promoting Healthy Eating and Physical Activity Behaviors: A Systematic Review of Multiple Health Behavior Change Interventions Among Cancer Survivors. [2023]

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

Evaluation of a Mobile Health Intervention to Improve Wellness Outcomes for Breast Cancer Survivors. [2022]