Heart and Blood Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Heart Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

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.

Each of the program components will have an individualized assessment with plan and goals set at the program intake visit.

Intake Session

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.

Individual Sessions

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.

Group Sessions

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

Graduation

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).

Exercise

Ivan Leung@ucsf.edu

Ivan Leung

Alexis Beatty, MD, MAS

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).

OBJECTIVES:

1. Evaluating feasibility and acceptability of the program.
2. 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.
3. 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.

Heart Health After Cancer Treatment (HEART-ACT)

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.

Analytic and community advisory board members will be provided with de-identified study data.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Heart Health After Cancer Treatment (HEART-ACT)	NCT06055803	Breast Cancer	Intake Session Individual Sess... Group Sessions Graduation Exercise	18 Years -	University of California, San Francisco
Heart Health After Cancer Treatment (HEART-ACT)	NCT06055803	Breast Cancer	Intake Session Individual Sess... Group Sessions Graduation Exercise	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for intake session