Heart Health After Cancer Treatment (HEART-ACT)

University of California San Francisco (UCSF)

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Behavioral: Intake Session; Behavioral: Graduation; Behavioral: Individual Sessions; Behavioral: Group Sessions; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06055803

228014

NCI-2023-07108 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Health Behavior Program

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise

Behavioral: Group Sessions

Behavioral: Individual Sessions

Behavioral: Graduation

Behavioral: Intake Session