Clinical trial NCT06055803: Heart Health After Cancer Treatment (HEART-ACT)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Health Behavioral Program
Cardiac Health
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with analyzable data for change in 6 Minute Walk Distance (6MWD)
timeFrame: Baseline to 12 months
measure: Proportion of participants with analyzable data for change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - Mental Scale
timeFrame: Baseline to 12 months
measure: Proportion of participants with analyzable data for change in PROMIS Global Health - Physical Health Scale
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Net Promoter Score
timeFrame: 3 Months
measure: Net Promoter Score
timeFrame: 6 Months
measure: Net Promoter Score
timeFrame: 12 Months
measure: Change in 6MWD
timeFrame: Baseline and 12 Months
measure: Change in 6MWD
timeFrame: Baseline and 6 Months
measure: Change in 6MWD
timeFrame: Baseline and 3 Months
measure: Change in PROMIS Global Health - Mental Scale
timeFrame: Baseline and 12 Months
measure: Change in PROMIS Global Health - Mental Scale
timeFrame: Baseline and 6 Months
measure: Change in PROMIS Global Health - Mental Scale
timeFrame: Baseline and 3 Months
measure: Change in PROMIS Global Health - Physical Scale
timeFrame: Baseline and 12 Months
measure: Change in PROMIS Global Health - Physical Scale
timeFrame: Baseline and 6 Months
measure: Change in PROMIS Global Health - Physical Scale
timeFrame: Baseline and 3 Months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General
state: California
Study officials:
affiliation: University of California, San Francisco
name: Alexis Beatty, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: