Heart Health After Cancer Treatment (HEART-ACT)

Study Overview
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Brief Summary
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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).

Detailed Description
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OBJECTIVES: Evaluating feasibility and acceptability of the program. Evaluating the effects of the program on health outcomes including change in exercise capacity, change in quality of life, change in risk factors, and adverse events. Evaluating changes in patient-reported measures. OUTLINE: Participants with a history of breast cancer who receive care at Zuckerberg San Francisco General Hospital (ZSFG) will receive the intervention which is comprised of a 12-week multi-disciplinary health behavior program. Each participant will have an individualized assessment, goal and plan for each component of the program. Follow-up for outcomes will occur at 3 months, 6 months, and 12 months.

Official Title
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The Heart Health After Cancer Treatment (HEART-ACT): A Pilot Study of a Multi-disciplinary Health Behavior Intervention in People With a History of Breast Cancer to Reduce Heart Disease Risk After Cancer Treatment.

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Intake Session
* Behavioral: Individual Sessions
* Behavioral: Group Sessions
* Behavioral: Graduation
* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18+ Diagnosis of breast cancer Treated with curative intent Able to communicate in English, Spanish, or Cantonese Able to consent for self Receive care at Zuckerberg San Francisco General Hospital Exclusion Criteria: Chemotherapy, radiation, or surgery planned in next 3 months Life expectancy < 1 year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Behavior Program<br>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. | Behavioral: Intake Session<br>* Each of the program components will have an individualized assessment with plan and goals set at the program intake visit.<br>Behavioral: Individual Sessions<br>* Individual sessions will occur in person or virtual every other week during the 12-week intervention with a health promotion specialist (nurse or exercise physiologist). These sessions will include review of progress towards goals, update exercise prescription, make plan for the next two weeks.<br>Behavioral: Group Sessions<br>* Group sessions for wellness and education will be delivered by medical multi-disciplinary staff in person or virtual every other week during the 12-week intervention.<br>Behavioral: Graduation<br>* At the conclusion of the 12-week intervention, there will be a graduation session to honor the participant's achievement and establish a plan for maintenance after the intervention<br>Behavioral: Exercise<br>* Participants will exercise as part of individual and group sessions. Participants will also be asked to exercise on their own, with a goal of working up to meeting US Physical Activity guidelines (150 minutes per week of moderate to vigorous exercise + 2 episodes of strength training).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with analyzable data for change in 6 Minute Walk Distance (6MWD) | 6MWD measures the distance walked over 6 minutes. The farther a person can walk indicates better exercise tolerance and mobility. The changes in distance will be compared at baseline and 12 months. We will measure the proportion of participants with analyzable 6MWD data. | Baseline to 12 months | 
| Proportion of participants with analyzable data for change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - Mental Scale | The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The mental health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better mental health. We will calculate the change in the score between baseline and 12 months. The proportion of participants who can have a score measured will be calculated. | Baseline to 12 months | 
| Proportion of participants with analyzable data for change in PROMIS Global Health - Physical Health Scale | The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health. We will calculate the change in the score between baseline and 12 months. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net Promoter Score | The Net Promoter Score asks the participant to report how likely they are to recommend this health behavior program to another breast cancer survivor on a scale of 1 (Very Unlikely) to 10 (Very Likely). The Score is calculated as the percent of respondents who are promoters reporting a 9 or 10 minus the percent of responders who are detractors reporting a 1-6. The score can range from -100 to 100, with 100 being the best score. | 3 Months | 
| Net Promoter Score | The Net Promoter Score asks the participant to report how likely they are to recommend this health behavior program to another breast cancer survivor on a scale of 1 (Very Unlikely) to 10 (Very Likely). The Score is calculated as the percent of respondents who are promoters reporting a 9 or 10 minus the percent of responders who are detractors reporting a 1-6. The score can range from -100 to 100, with 100 being the best score. | 6 Months | 
| Net Promoter Score | The Net Promoter Score asks the participant to report how likely they are to recommend this health behavior program to another breast cancer survivor on a scale of 1 (Very Unlikely) to 10 (Very Likely). The Score is calculated as the percent of respondents who are promoters reporting a 9 or 10 minus the percent of responders who are detractors reporting a 1-6. The score can range from -100 to 100, with 100 being the best score. | 12 Months | 
| Change in 6MWD | 6MWD measures the distance walked over 6 minutes. The farther a person can walk indicates better exercise tolerance and mobility. The changes in distance will be compared at baseline and 12 months. | Baseline and 12 Months | 
| Change in 6MWD | 6MWD measures the distance walked over 6 minutes. The farther a person can walk indicates better exercise tolerance and mobility. The changes in distance will be compared at baseline and 6 months. | Baseline and 6 Months | 
| Change in 6MWD | 6MWD measures the distance walked over 6 minutes. The farther a person can walk indicates better exercise tolerance and mobility. The changes in distance will be compared at baseline and 3 months. | Baseline and 3 Months | 
| Change in PROMIS Global Health - Mental Scale | The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The mental health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better mental health. We will calculate the change in the score between baseline and 12 months. | Baseline and 12 Months | 
| Change in PROMIS Global Health - Mental Scale | The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The mental health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better mental health. We will calculate the change in the score between baseline and 6 months. | Baseline and 6 Months | 
| Change in PROMIS Global Health - Mental Scale | The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The mental health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better mental health. We will calculate the change in the score between baseline and 3 months. | Baseline and 3 Months | 
| Change in PROMIS Global Health - Physical Scale | The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health. We will calculate the change in the score between baseline and 12 months. | Baseline and 12 Months | 
| Change in PROMIS Global Health - Physical Scale | The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health. We will calculate the change in the score between baseline and 6 months. | Baseline and 6 Months | 
| Change in PROMIS Global Health - Physical Scale | The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health. We will calculate the change in the score between baseline and 3 months. | Baseline and 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Behavioral Program, Cardiac Health