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Completed

NCT Number: NCT06055803

Heart Health After Cancer Treatment (HEART-ACT)

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuckerberg San Francisco General

San Francisco, California, 94115, United States

About this study

OBJECTIVES:

  • Evaluating feasibility and acceptability of the program.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intake Session

Behavioral

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

Individual Sessions

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

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

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

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).

Primary outcomes

  1. Proportion of participants with analyzable data for change in 6 Minute Walk Distance (6MWD)

    Time frame: Baseline to 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 12 months. We will measure the proportion of participants with analyzable 6MWD data.

  2. Proportion of participants with analyzable data for change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - Mental Scale

    Time frame: Baseline to 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 12 months. The proportion of participants who can have a score measured will be calculated.

  3. Proportion of participants with analyzable data for change in PROMIS Global Health - Physical Health Scale

    Time frame: Baseline to 12 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 12 months.

Secondary outcomes

  1. Net Promoter Score

    Time frame: 3 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.

  2. Net Promoter Score

    Time frame: 6 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.

  3. Net Promoter Score

    Time frame: 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.

  4. Change in 6MWD

    Time frame: 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 12 months.

  5. Change in 6MWD

    Time frame: 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 6 months.

  6. Change in 6MWD

    Time frame: Baseline and 3 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.

  7. Change in PROMIS Global Health - Mental Scale

    Time frame: 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 12 months.

  8. Change in PROMIS Global Health - Mental Scale

    Time frame: 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 6 months.

  9. Change in PROMIS Global Health - Mental Scale

    Time frame: 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 3 months.

  10. Change in PROMIS Global Health - Physical Scale

    Time frame: Baseline and 12 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 12 months.

  11. Change in PROMIS Global Health - Physical Scale

    Time frame: 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 6 months.

  12. Change in PROMIS Global Health - Physical Scale

    Time frame: 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 3 months.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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