Breast CancerNCT06055803
Heart Health After Cancer Treatment (HEART-ACT)
A study testing Intake Session, Individual Sessions and Group Sessions in people with Breast Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intake Session, Individual Sessions and Group Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Chemotherapy, radiation, or surgery planned in next 3 months
- Life expectancy < 1 year
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General
San Francisco, California, 94115
About this study
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.
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).
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Intake Session, Individual Sessions, Group Sessions, Graduation, Exercise
- Keywords
- Health Behavioral Program, Cardiac Health
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intake SessionBehavioural
Each of the program components will have an individualized assessment with plan and goals set at the program intake visit.
Individual SessionsBehavioural
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 SessionsBehavioural
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.
GraduationBehavioural
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
ExerciseBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Health Behavior Program | Experimental | 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. Receives: Behavioral: Intake Session; Behavioral: Individual Sessions; Behavioral: Group Sessions; Behavioral: Graduation; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start7 Nov 2023
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Beatty, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055803
- Sponsor's protocol ID
- 228014
- Other IDs
- NCI-2023-07108
- Status last verified
- May 2026
- First submitted
- 20 Sep 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analytic and community advisory board members will be provided with de-identified study data.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06055803
- Acronym / sponsor ID
- 228014
- Conditions
- Breast Cancer
- Keywords
- Health Behavioral Program, Cardiac Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Behavior Program | Experimental | Behavioral: Intake Session, Behavioral: Individual Sessions, Behavioral: Group Sessions, Behavioral: Graduation, Behavioral: ExerciseEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18+
- Diagnosis of breast cancer
- Treated with curative intent
- Able to communicate in English, Spanish, or Cantonese
- Able to consent for self
Key exclusion criteria (2 listed)
- Chemotherapy, radiation, or surgery planned in next 3 months
- Life expectancy < 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intake SessionEach of the program components will have an individualized assessment with plan and goals set at the program intake visit. | Behavioural | Health Behavior Program |
| Individual SessionsIndividual 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. | Behavioural | Health Behavior Program |
| Group SessionsGroup 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. | Behavioural | Health Behavior Program |
| GraduationAt 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 | Behavioural | Health Behavior Program |
| ExerciseParticipants 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). | Behavioural | Health Behavior Program |
Primary outcome
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.
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.
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.
12 secondary outcomes
Net Promoter Score
Time frame: 3 Months
Net Promoter Score
Time frame: 6 Months
Net Promoter Score
Time frame: 12 Months
Change in 6MWD
Time frame: Baseline and 12 Months
Change in 6MWD
Time frame: Baseline and 6 Months
Change in 6MWD
Time frame: Baseline and 3 Months
Change in PROMIS Global Health - Mental Scale
Time frame: Baseline and 12 Months
Change in PROMIS Global Health - Mental Scale
Time frame: Baseline and 6 Months
Change in PROMIS Global Health - Mental Scale
Time frame: Baseline and 3 Months
Change in PROMIS Global Health - Physical Scale
Time frame: Baseline and 12 Months
Change in PROMIS Global Health - Physical Scale
Time frame: Baseline and 6 Months
Change in PROMIS Global Health - Physical Scale
Time frame: Baseline and 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. Analytic and community advisory board members will be provided with de-identified study data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Beatty, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intake Session, Individual Sessions and Group Sessions in people with Breast Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with analyzable data for change in 6 Minute Walk Distance (6MWD) (time frame: Baseline to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.