Heart Health After Cancer Treatment (HEART-ACT)

NCT ID: NCT06055803

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-07

Study Completion Date

2026-06-30

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:

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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intake Session

Intervention Type BEHAVIORAL

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

Individual Sessions

Intervention Type BEHAVIORAL

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.

Group Sessions

Intervention Type BEHAVIORAL

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.

Graduation

Intervention Type BEHAVIORAL

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

Exercise

Intervention Type BEHAVIORAL

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).

Interventions

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Intake Session

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

Intervention Type 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.

Intervention Type 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.

Intervention Type 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

Intervention Type 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).

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexis Beatty, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Zuckerberg San Francisco General

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2023-07108

Identifier Type: REGISTRY

Identifier Source: secondary_id

228014

Identifier Type: -

Identifier Source: org_study_id

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