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.

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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Intake Session; Behavioral: Individual Sessions; Behavioral: Group Sessions; Behavioral: Graduation; Behavioral: Exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Zuckerberg San Francisco General

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Health Behavior Program; 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; Each of the program components will have an individualized assessment with plan and goals set at the program intake visit.; Behavioral: Individual Sessions; 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.; Behavioral: Group 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.; Behavioral: Graduation; 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; Behavioral: Exercise; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Alexis Beatty, MD, MAS, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2023
• Primary Completion (Actual): March 31, 2026
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Health Behavioral Program; Cardiac Health
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 228014; NCI-2023-07108 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Analytic and community advisory board members will be provided with de-identified study data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No