Breast NeoplasmAH-HANCT03935282
Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors
A study testing AH-HA Tool in the EPIC EHR in people with Breast Neoplasm and Prostatic Neoplasm, run by Wake Forest University Health Sciences at 12 sites in United States.
Trial summary
The objective of this hybrid effectiveness-implementation study is to examine the effects of an EHR-based cardiovascular health assessment tool (AH-HA) among breast, prostate, colorectal, endometrial, and Hodgkin and non-Hodgkin lymphoma cancer survivors (N=600) receiving survivorship care in community oncology… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm, Prostatic Neoplasm, Colorectal Neoplasms
- What is being tested?
- AH-HA Tool in the EPIC EHR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 645 participants
- Where
- 12 sitesUnited States
- Study dates
- 1 Oct 2020to 17 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- >= 6 months post-potentially curative cancer treatment for breast, prostate, colorectal, or endometrial cancers or Hodgkin and non-Hodgkin lymphomas. Ongoing hormonal therapies such as tamoxifen, aromatase inhibitors (with or without adjuvant CDK 4/6 inhibitors such as abemaciclib), or androgen deprivation are allowed.
- Scheduled for a routine cancer-related follow-up care visit within the next 30 days with a provider who received training to use AH-HA.
- Able and willing to complete a follow-up assessment in one year.
- Survivors must have no evidence of disease at the time of last medical visit for all cancers, except non-melanoma skin disease.
- Age >= 18 years.
- Able to understand and willing to provide verbal informed consent.
Who cannot join
- Survivors will be excluded if they have a history of cancer recurrence for any cancer other than non-melanoma skin disease.
- Prostate patients on active surveillance will be excluded.
- Survivor does not speak English or Spanish.
- Survivors who are currently on another interventional protocol in which cardiovascular risk factors (e.g., blood pressure, smoking, diet, physical activity) are being addressed, as per patient self-report or research staff members' knowledge at the time of consent.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Baptist Memorial Hospital for Women
Memphis, Tennessee, 38120
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Community Medical Center
Scranton, Pennsylvania, 18510
Mercy Hospital Springfield
Springfield, Missouri, 65804
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
About this study
Official title: Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors (AH-HA)
The objective of this hybrid effectiveness-implementation study is to examine the effects of an EHR-based cardiovascular health assessment tool (AH-HA) among breast, prostate, colorectal, endometrial, and Hodgkin and non-Hodgkin lymphoma cancer survivors (N=600) receiving survivorship care in community oncology practices, using a group-randomized trial design (6 intervention practices and 6 usual care practices). Our central hypothesis is that the AH-HA tool will increase (1) cardiovascular health (CVH) discussions among survivors and oncology providers, (2) referrals and visits to primary care and cardiology (care coordination), and (3) cardiovascular (CV) risk reduction and health promotion activities compared to usual care.
Read the detailed description
In this hybrid effectiveness-implementation group-randomized clinical trial, 6 intervention practices will receive an EHR-based cardiovascular health assessment tool (Automated Heart Health Assessment for Survivors: AH-HA) and 6 practices will serve as usual care (control) practices without access to the AH-HA tool. AH-HA renders a visual, interactive display of CVH risk factors, automatically populated from the EHR. This tool was first implemented in primary care and now incorporates EHR data on receipt of cancer treatments with cardiotoxic potential. Providers at each intervention site will be trained to use the tool during routine follow-up care with survivors. Eligible survivors with breast, prostate, colorectal, endometrial, or Hodgkin and non-Hodgkin lymphoma cancer (n=600) will provide baseline data before and immediately after seeing their oncology provider and complete 6-month and 1-year study follow-up visits. The study team will compare changes in outcomes from baseline to 1-year in survivors at the intervention and usual care clinics using data from survivor self-reports and the EHR. The primary outcome is CVH discussions defined as the number of patient-reported discussions with their provider regarding up to seven non-ideal CVH conditions identified for that patient during oncology visits. Secondary outcomes include referrals to primary care and cardiology, provider efforts to manage CV risk, survivors' completed visits with primary care providers and cardiologists, and control of CVH factors and behaviors. Implementation metrics will be assessed using data from the EHR and semi-structured interviews with providers and administrators (n=24-30) at intervention clinics.
- Conditions
- Breast Neoplasm, Prostatic Neoplasm, Colorectal Neoplasms, Endometrial Neoplasms, Hodgkin Disease, Non Hodgkin Lymphoma
- Being tested
- AH-HA Tool in the EPIC EHR
- Keywords
- Cardiovascular risk, Cardiovascular disease, Cancer, Survivor, Health Behaviors, Oncology Providers, EHR, Informatics
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Hodgkin Disease, Lymphoma, Non-Hodgkin, Cardiovascular Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AH-HA Tool in the EPIC EHROther
The Automated Heart-Health Assessment tool implemented in clinics' EPIC EHR will be used by providers during routine follow-up care appointments.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - AH-HA tool | Experimental | With assistance from the study team, the clinic will implement the AH-HA tool in the clinics' EPIC EHR. Providers at the intervention sites will be trained to use the tool during routine follow-up care with survivors. During a routine follow-up care appointment, the provider will use the AH-HA tool with enrolled patients. Receives: Other: AH-HA Tool in the EPIC EHR |
| Usual Care | No intervention | Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Reporting Discussion of at Least One Non-ideal or Missing CVH Topic
Discussion of non-ideal cardiovascular health (CVH) factors (yes or no). CVH discussions will be defined as patient-reported discussions with their provider for any of the seven non-ideal CVH conditions identified for that patient. Conditions include CVH factors (cholesterol, blood pressure, glucose/hemoglobin A1c) and CVH behaviors (body mass index, smoking, diet, and physical activity). Measured using survivor survey (discussions, diet, and primary care) and EHR for other CVH factors.
Measured: Baseline
Secondary outcomes (33)
Referrals to Primary Care to Manage CV Risk
Medical chart abstraction of referrals to providers regarding CVH at survivor baseline visit.
Measured: Baseline
Referrals to Cardiology to Manage CV Risk
Medical chart abstraction of referrals to providers regarding CVH at survivor baseline visit.
Measured: Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Test
Medical chart abstraction.
Measured: Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Glucose Test
Medical chart abstraction.
Measured: Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: A1c Test
Medical chart abstraction.
Measured: Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Medication
Medical chart abstraction.
Measured: Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Diabetes Medication
Medical chart abstraction.
Measured: Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Blood Pressure Medication
Medical chart abstraction.
Measured: Baseline
Any Completed Visits With Primary Care Providers
Medical chart abstraction of completed visits to providers regarding CVH one year from survivor baseline visit
Measured: 1 year
Any Completed Visits With Cardiology Providers
Medical chart abstraction of completed visits to providers regarding CVH one year from survivor baseline visit
Measured: 1 year
Change in CVH Behaviors Recorded in the Past Year: Smoking Status
Medical chart abstraction; Patient survey as secondary, verification source. Proportion of participants who were non-smoking at 1-year, of those who were smoking at baseline.
Measured: 1 year
Change in CVH Behaviors Recorded in the Past Year: BMI
Medical chart abstraction; Patient survey as secondary, verification source. Change in BMI from baseline to 1-year.
Measured: 1 year
Change in CVH Behaviors Recorded in the Past Year: Physical Activity
Medical chart abstraction; Patient survey as secondary, verification source. Change in total minutes of physical activity per week from baseline to 1-year.
Measured: 1 year
Change in CVH Behaviors Recorded in the Past Year: Healthy Diet Score
Medical chart abstraction; Patient survey as secondary, verification source. Change in healthy diet score from baseline to 1-year. Healthy diet score is calculated from the sum of 5 diet questions (range: 0-5) with higher scores indicating a healthier diet.
Measured: 1 year
Change in CVH Factors Recorded in the Past Year: Total Cholesterol
Medical chart abstraction; Patient survey as secondary, verification source. Change in total cholesterol from baseline to 1-year.
Measured: 1 year
Change in CVH Factors Recorded in the Past Year: Systolic Blood Pressure
Medical chart abstraction; Patient survey as secondary, verification source. Change in systolic blood pressure l from baseline to 1-year.
Measured: 1 year
Change in CVH Factors Recorded in the Past Year: Diastolic Blood Pressure
Medical chart abstraction; Patient survey as secondary, verification source. Change in diastolic blood pressure l from baseline to 1-year.
Measured: 1 year
Change in CVH Factors Recorded in the Past Year: A1c
Medical chart abstraction; Patient survey as secondary, verification source. Change in A1c from baseline to 1-year.
Measured: 1 year
Change in CVH Factors Recorded in the Past Year: Glucose
Medical chart abstraction; Patient survey as secondary, verification source. Change in glucose from baseline to 1-year.
Measured: 1 year
Patient Perception and Knowledge of CV Risks: I am Confident I Understand my Risk of Heart Disease
Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.
Measured: Baseline
Patient Perception and Knowledge of CV Risks: I Understand What Steps I Need to Take to Maintain or Improve my Heart Health
Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.
Measured: Baseline
Patient Perception and Knowledge of CV Risks: I Plan to Take Steps to Maintain or Improve my Heart Health Within the Next Year
Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.
Measured: Baseline
Patient Perception and Knowledge of CV Risks: Cancer Poses a Risk to my Health
Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.
Measured: Baseline
Patient Perception and Knowledge of CV Risks: Heart Disease Poses a Risk to my Health
Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.
Measured: Baseline
Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Oncology Provider About my Heart Health
Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.
Measured: Baseline
Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Primary Care Provider About my Heart Health
Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.
Measured: Baseline
Patient Perception and Knowledge of CV Risks: Oncology Providers Should Talk to Their Patients About Their Heart Health
Measured using structured survivor survey. Health knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular disease in United States populations. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Models are estimating the proportion of participants who answered the question as Neutral/Disagree/Strongly Disagree at pre-visit baseline who then answered Agree/Strongly Agree at post-visit baseline.
Measured: Baseline
Proportion of Survivors for Whom AH-HA is Utilized
We will capture the number of eligible patient visits during which the AH-HA tool was used in intervention clinics and the total number of eligible visits to calculate the proportion of patients where AH-HA was utilized.
Measured: Baseline
Measure of Tool Acceptability With Tool Assessment: I Liked the Heart Health Tool I Used Today With my Provider
In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree.
Measured: Baseline
Measure of Tool Acceptability With Tool Assessment: It Was Helpful to See my Heart Health Score
In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree.
Measured: Baseline
Measure of Tool Acceptability With Tool Assessment: I Found the Heart Health Tool Easy to Understand
In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree.
Measured: Baseline
Measure of Tool Acceptability With Tool Assessment: The Picture/Diagram Improved my Understanding of Heart Health
In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree.
Measured: Baseline
Measure of Tool Acceptability With Tool Assessment: I Would Like to Use This Tool to Talk About my Heart Health With my Oncology Provider at a Future Appointment
In the Baseline: Post-Visit Survey, survivors will complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, how easy it was to understand, how much it improved their understanding, and if they would like to use this tool in the future. Questions were asked on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Responses were categorizes as Agree/Strongly Agree or Neutral/Disagree/Strongly Disagree. Frequencies are presented for participants responding with Agree/Strongly Agree.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Oct 2020
- Primary completion7 Mar 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (118)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 645 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Washington University School of Medicine, University of Texas Southwestern Medical Center
- Responsible party
- Sponsor
- Investigators
- Kathryn Weaver, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935282
- Sponsor's protocol ID
- IRB00056774
- Other IDs
- NCI-2019-01362, R01CA226078, NCI-2019-01362
- Acronym
- AH-HA
- Status last verified
- Mar 2026
- First submitted
- 11 Apr 2019
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
Publications
Shelburne N, Adhikari B, Brell J, Davis M, Desvigne-Nickens P, Freedman A, Minasian L, Force T, Remick SC. Cancer treatment-related cardiotoxicity: current state of knowledge and future research priorities. J Natl Cancer Inst. 2014 Sep 10;106(9):dju232. doi: 10.1093/jnci/dju232. Print 2014 Sep.
PubMed 25210198Lajous M, Mozaffarian D, Mozaffarian R, Schrag D, Adami HO. Lifestyle prescriptions for cancer survivors and their communities. J Intern Med. 2011 Jan;269(1):88-93. doi: 10.1111/j.1365-2796.2010.02273.x. Epub 2010 Sep 24.
PubMed 21158981Patnaik JL, Byers T, DiGuiseppi C, Dabelea D, Denberg TD. Cardiovascular disease competes with breast cancer as the leading cause of death for older females diagnosed with breast cancer: a retrospective cohort study. Breast Cancer Res. 2011 Jun 20;13(3):R64. doi: 10.1186/bcr2901.
PubMed 21689398van Erning FN, van Steenbergen LN, Lemmens VEPP, Rutten HJT, Martijn H, van Spronsen DJ, Janssen-Heijnen MLG. Conditional survival for long-term colorectal cancer survivors in the Netherlands: who do best? Eur J Cancer. 2014 Jul;50(10):1731-1739. doi: 10.1016/j.ejca.2014.04.009. Epub 2014 May 6.
PubMed 24814358Ward KK, Shah NR, Saenz CC, McHale MT, Alvarez EA, Plaxe SC. Cardiovascular disease is the leading cause of death among endometrial cancer patients. Gynecol Oncol. 2012 Aug;126(2):176-9. doi: 10.1016/j.ygyno.2012.04.013. Epub 2012 Apr 13.
PubMed 22507532Underwood JM, Townsend JS, Stewart SL, Buchannan N, Ekwueme DU, Hawkins NA, Li J, Peaker B, Pollack LA, Richards TB, Rim SH, Rohan EA, Sabatino SA, Smith JL, Tai E, Townsend GA, White A, Fairley TL; Division of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (CDC). Surveillance of demographic characteristics and health behaviors among adult cancer survivors--Behavioral Risk Factor Surveillance System, United States, 2009. MMWR Surveill Summ. 2012 Jan 20;61(1):1-23.
PubMed 22258477Foraker RE, Abdel-Rasoul M, Kuller LH, Jackson RD, Van Horn L, Seguin RA, Safford MM, Wallace RB, Kucharska-Newton AM, Robinson JG, Martin LW, Agha G, Hou L, Allen NB, Tindle HA. Cardiovascular Health and Incident Cardiovascular Disease and Cancer: The Women's Health Initiative. Am J Prev Med. 2016 Feb;50(2):236-40. doi: 10.1016/j.amepre.2015.07.039. Epub 2015 Oct 9.
PubMed 26456876Folsom AR, Yatsuya H, Nettleton JA, Lutsey PL, Cushman M, Rosamond WD; ARIC Study Investigators. Community prevalence of ideal cardiovascular health, by the American Heart Association definition, and relationship with cardiovascular disease incidence. J Am Coll Cardiol. 2011 Apr 19;57(16):1690-6. doi: 10.1016/j.jacc.2010.11.041.
PubMed 21492767Rasmussen-Torvik LJ, Shay CM, Abramson JG, Friedrich CA, Nettleton JA, Prizment AE, Folsom AR. Ideal cardiovascular health is inversely associated with incident cancer: the Atherosclerosis Risk In Communities study. Circulation. 2013 Mar 26;127(12):1270-5. doi: 10.1161/CIRCULATIONAHA.112.001183. Epub 2013 Mar 18.
PubMed 23509058Kulshreshtha A, Vaccarino V, Judd SE, Howard VJ, McClellan WM, Muntner P, Hong Y, Safford MM, Goyal A, Cushman M. Life's Simple 7 and risk of incident stroke: the reasons for geographic and racial differences in stroke study. Stroke. 2013 Jul;44(7):1909-14. doi: 10.1161/STROKEAHA.111.000352. Epub 2013 Jun 6.
PubMed 23743971Hurt RD, Ebbert JO, Hays JT, McFadden DD. Preventing lung cancer by treating tobacco dependence. Clin Chest Med. 2011 Dec;32(4):645-57. doi: 10.1016/j.ccm.2011.08.004.
PubMed 22054877Byers T, Sedjo RL. Does intentional weight loss reduce cancer risk? Diabetes Obes Metab. 2011 Dec;13(12):1063-72. doi: 10.1111/j.1463-1326.2011.01464.x.
PubMed 21733057Thomson CA, Rock CL, Thompson PA, Caan BJ, Cussler E, Flatt SW, Pierce JP. Vegetable intake is associated with reduced breast cancer recurrence in tamoxifen users: a secondary analysis from the Women's Healthy Eating and Living Study. Breast Cancer Res Treat. 2011 Jan;125(2):519-27. doi: 10.1007/s10549-010-1014-9. Epub 2010 Jul 6.
PubMed 20607600Oeffinger KC, Tonorezos ES. The cancer is over, now what?: Understanding risk, changing outcomes. Cancer. 2011 May 15;117(10 Suppl):2250-7. doi: 10.1002/cncr.26051.
PubMed 21523742Davies NJ, Batehup L, Thomas R. The role of diet and physical activity in breast, colorectal, and prostate cancer survivorship: a review of the literature. Br J Cancer. 2011 Nov 8;105 Suppl 1(Suppl 1):S52-73. doi: 10.1038/bjc.2011.423.
PubMed 22048034
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors (AH-HA)
- ClinicalTrials.gov ID
- NCT03935282
- Acronym / sponsor ID
- AH-HA / IRB00056774
- Conditions
- Breast Neoplasm, Prostatic Neoplasm, Colorectal Neoplasms, Endometrial Neoplasms, Hodgkin Disease, Non Hodgkin Lymphoma
- Keywords
- Cardiovascular risk, Cardiovascular disease, Cancer, Survivor, Health Behaviors, Oncology Providers, EHR, Informatics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 645 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Washington University School of Medicine, University of Texas Southwestern Medical Center
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Posted 15 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this hybrid effectiveness-implementation study is to examine the effects of an EHR-based cardiovascular health assessment tool (AH-HA) among breast, prostate, colorectal, endometrial, and Hodgkin and non-Hodgkin lymphoma cancer survivors (N=600) receiving survivorship care in community oncology practices, using a group-randomized trial design (6 intervention practices and 6 usual care practices). Our central hypothesis is that the AH-HA tool will increase (1) cardiovascular health (CVH) discussions among survivors and oncology providers, (2) referrals and visits to primary care and cardiology (care coordination), and (3) cardiovascular (CV) risk reduction and health promotion activities compared to usual care.
Detailed description
In this hybrid effectiveness-implementation group-randomized clinical trial, 6 intervention practices will receive an EHR-based cardiovascular health assessment tool (Automated Heart Health Assessment for Survivors: AH-HA) and 6 practices will serve as usual care (control) practices without access to the AH-HA tool. AH-HA renders a visual, interactive display of CVH risk factors, automatically populated from the EHR. This tool was first implemented in primary care and now incorporates EHR data on receipt of cancer treatments with cardiotoxic potential. Providers at each intervention site will be trained to use the tool during routine follow-up care with survivors. Eligible survivors with breast, prostate, colorectal, endometrial, or Hodgkin and non-Hodgkin lymphoma cancer (n=600) will provide baseline data before and immediately after seeing their oncology provider and complete 6-month and 1-year study follow-up visits. The study team will compare changes in outcomes from baseline to 1-year in survivors at the intervention and usual care clinics using data from survivor self-reports and the EHR. The primary outcome is CVH discussions defined as the number of patient-reported discussions with their provider regarding up to seven non-ideal CVH conditions identified for that patient during oncology visits. Secondary outcomes include referrals to primary care and cardiology, provider efforts to manage CV risk, survivors' completed visits with primary care providers and cardiologists, and control of CVH factors and behaviors. Implementation metrics will be assessed using data from the EHR and semi-structured interviews with providers and administrators (n=24-30) at intervention clinics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - AH-HA tool | Experimental | Other: AH-HA Tool in the EPIC EHRWith assistance from the study team, the clinic will implement the AH-HA tool in the clinics' EPIC EHR. Providers at the intervention sites will be trained to use the tool during routine follow-up care with survivors. During a routine follow-up care appointment, the provider will use the AH-HA tool with enrolled patients. |
| Usual Care | No intervention | –Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >= 6 months post-potentially curative cancer treatment for breast, prostate, colorectal, or endometrial cancers or Hodgkin and non-Hodgkin lymphomas. Ongoing hormonal therapies such as tamoxifen, aromatase inhibitors (with or without adjuvant CDK 4/6 inhibitors such as abemaciclib), or androgen deprivation are allowed.
- Scheduled for a routine cancer-related follow-up care visit within the next 30 days with a provider who received training to use AH-HA.
- Able and willing to complete a follow-up assessment in one year.
- Survivors must have no evidence of disease at the time of last medical visit for all cancers, except non-melanoma skin disease.
- Age >= 18 years.
Key exclusion criteria (4 listed)
- Survivors will be excluded if they have a history of cancer recurrence for any cancer other than non-melanoma skin disease.
- Prostate patients on active surveillance will be excluded.
- Survivor does not speak English or Spanish.
- Survivors who are currently on another interventional protocol in which cardiovascular risk factors (e.g., blood pressure, smoking, diet, physical activity) are being addressed, as per patient self-report or research staff members' knowledge at the time of consent.
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 |
|---|---|---|
| AH-HA Tool in the EPIC EHRThe Automated Heart-Health Assessment tool implemented in clinics' EPIC EHR will be used by providers during routine follow-up care appointments. | Other | Intervention - AH-HA tool |
Primary outcome
Proportion of Patients Reporting Discussion of at Least One Non-ideal or Missing CVH Topic
Time frame: Baseline
Discussion of non-ideal cardiovascular health (CVH) factors (yes or no). CVH discussions will be defined as patient-reported discussions with their provider for any of the seven non-ideal CVH conditions identified for that patient. Conditions include CVH factors (cholesterol, blood pressure, glucose/hemoglobin A1c) and CVH behaviors (body mass index, smoking, diet, and physical activity). Measured using survivor survey (discussions, diet, and primary care) and EHR for other CVH factors.
33 secondary outcomes
Referrals to Primary Care to Manage CV Risk
Time frame: Baseline
Referrals to Cardiology to Manage CV Risk
Time frame: Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Test
Time frame: Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Glucose Test
Time frame: Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: A1c Test
Time frame: Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Medication
Time frame: Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Diabetes Medication
Time frame: Baseline
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Blood Pressure Medication
Time frame: Baseline
Any Completed Visits With Primary Care Providers
Time frame: 1 year
Any Completed Visits With Cardiology Providers
Time frame: 1 year
Change in CVH Behaviors Recorded in the Past Year: Smoking Status
Time frame: 1 year
Change in CVH Behaviors Recorded in the Past Year: BMI
Time frame: 1 year
Change in CVH Behaviors Recorded in the Past Year: Physical Activity
Time frame: 1 year
Change in CVH Behaviors Recorded in the Past Year: Healthy Diet Score
Time frame: 1 year
Change in CVH Factors Recorded in the Past Year: Total Cholesterol
Time frame: 1 year
Change in CVH Factors Recorded in the Past Year: Systolic Blood Pressure
Time frame: 1 year
Change in CVH Factors Recorded in the Past Year: Diastolic Blood Pressure
Time frame: 1 year
Change in CVH Factors Recorded in the Past Year: A1c
Time frame: 1 year
Change in CVH Factors Recorded in the Past Year: Glucose
Time frame: 1 year
Patient Perception and Knowledge of CV Risks: I am Confident I Understand my Risk of Heart Disease
Time frame: Baseline
Patient Perception and Knowledge of CV Risks: I Understand What Steps I Need to Take to Maintain or Improve my Heart Health
Time frame: Baseline
Patient Perception and Knowledge of CV Risks: I Plan to Take Steps to Maintain or Improve my Heart Health Within the Next Year
Time frame: Baseline
Patient Perception and Knowledge of CV Risks: Cancer Poses a Risk to my Health
Time frame: Baseline
Patient Perception and Knowledge of CV Risks: Heart Disease Poses a Risk to my Health
Time frame: Baseline
Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Oncology Provider About my Heart Health
Time frame: Baseline
Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Primary Care Provider About my Heart Health
Time frame: Baseline
Patient Perception and Knowledge of CV Risks: Oncology Providers Should Talk to Their Patients About Their Heart Health
Time frame: Baseline
Proportion of Survivors for Whom AH-HA is Utilized
Time frame: Baseline
Measure of Tool Acceptability With Tool Assessment: I Liked the Heart Health Tool I Used Today With my Provider
Time frame: Baseline
Measure of Tool Acceptability With Tool Assessment: It Was Helpful to See my Heart Health Score
Time frame: Baseline
Measure of Tool Acceptability With Tool Assessment: I Found the Heart Health Tool Easy to Understand
Time frame: Baseline
Measure of Tool Acceptability With Tool Assessment: The Picture/Diagram Improved my Understanding of Heart Health
Time frame: Baseline
Measure of Tool Acceptability With Tool Assessment: I Would Like to Use This Tool to Talk About my Heart Health With my Oncology Provider at a Future Appointment
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25210198Shelburne N, Adhikari B, Brell J, Davis M, Desvigne-Nickens P, Freedman A, Minasian L, Force T, Remick SC. Cancer treatment-related cardiotoxicity: current state of knowledge and future research priorities. J Natl Cancer Inst. 2014 Sep 10;106(9):dju232. doi: 10.1093/jnci/dju232. Print 2014 Sep.
- Background: PubMed 21158981Lajous M, Mozaffarian D, Mozaffarian R, Schrag D, Adami HO. Lifestyle prescriptions for cancer survivors and their communities. J Intern Med. 2011 Jan;269(1):88-93. doi: 10.1111/j.1365-2796.2010.02273.x. Epub 2010 Sep 24.
- Background: PubMed 21689398Patnaik JL, Byers T, DiGuiseppi C, Dabelea D, Denberg TD. Cardiovascular disease competes with breast cancer as the leading cause of death for older females diagnosed with breast cancer: a retrospective cohort study. Breast Cancer Res. 2011 Jun 20;13(3):R64. doi: 10.1186/bcr2901.
- Background: PubMed 24814358van Erning FN, van Steenbergen LN, Lemmens VEPP, Rutten HJT, Martijn H, van Spronsen DJ, Janssen-Heijnen MLG. Conditional survival for long-term colorectal cancer survivors in the Netherlands: who do best? Eur J Cancer. 2014 Jul;50(10):1731-1739. doi: 10.1016/j.ejca.2014.04.009. Epub 2014 May 6.
- Background: PubMed 22507532Ward KK, Shah NR, Saenz CC, McHale MT, Alvarez EA, Plaxe SC. Cardiovascular disease is the leading cause of death among endometrial cancer patients. Gynecol Oncol. 2012 Aug;126(2):176-9. doi: 10.1016/j.ygyno.2012.04.013. Epub 2012 Apr 13.
- Background: PubMed 22258477Underwood JM, Townsend JS, Stewart SL, Buchannan N, Ekwueme DU, Hawkins NA, Li J, Peaker B, Pollack LA, Richards TB, Rim SH, Rohan EA, Sabatino SA, Smith JL, Tai E, Townsend GA, White A, Fairley TL; Division of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (CDC). Surveillance of demographic characteristics and health behaviors among adult cancer survivors--Behavioral Risk Factor Surveillance System, United States, 2009. MMWR Surveill Summ. 2012 Jan 20;61(1):1-23.
- Background: PubMed 26456876Foraker RE, Abdel-Rasoul M, Kuller LH, Jackson RD, Van Horn L, Seguin RA, Safford MM, Wallace RB, Kucharska-Newton AM, Robinson JG, Martin LW, Agha G, Hou L, Allen NB, Tindle HA. Cardiovascular Health and Incident Cardiovascular Disease and Cancer: The Women's Health Initiative. Am J Prev Med. 2016 Feb;50(2):236-40. doi: 10.1016/j.amepre.2015.07.039. Epub 2015 Oct 9.
- Background: PubMed 21492767Folsom AR, Yatsuya H, Nettleton JA, Lutsey PL, Cushman M, Rosamond WD; ARIC Study Investigators. Community prevalence of ideal cardiovascular health, by the American Heart Association definition, and relationship with cardiovascular disease incidence. J Am Coll Cardiol. 2011 Apr 19;57(16):1690-6. doi: 10.1016/j.jacc.2010.11.041.
- Background: PubMed 23509058Rasmussen-Torvik LJ, Shay CM, Abramson JG, Friedrich CA, Nettleton JA, Prizment AE, Folsom AR. Ideal cardiovascular health is inversely associated with incident cancer: the Atherosclerosis Risk In Communities study. Circulation. 2013 Mar 26;127(12):1270-5. doi: 10.1161/CIRCULATIONAHA.112.001183. Epub 2013 Mar 18.
- Background: PubMed 23743971Kulshreshtha A, Vaccarino V, Judd SE, Howard VJ, McClellan WM, Muntner P, Hong Y, Safford MM, Goyal A, Cushman M. Life's Simple 7 and risk of incident stroke: the reasons for geographic and racial differences in stroke study. Stroke. 2013 Jul;44(7):1909-14. doi: 10.1161/STROKEAHA.111.000352. Epub 2013 Jun 6.
- Background: PubMed 22054877Hurt RD, Ebbert JO, Hays JT, McFadden DD. Preventing lung cancer by treating tobacco dependence. Clin Chest Med. 2011 Dec;32(4):645-57. doi: 10.1016/j.ccm.2011.08.004.
- Background: PubMed 21733057Byers T, Sedjo RL. Does intentional weight loss reduce cancer risk? Diabetes Obes Metab. 2011 Dec;13(12):1063-72. doi: 10.1111/j.1463-1326.2011.01464.x.
- Individual participant dataSharing planned: Yes. Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
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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.
Kathryn Weaver, MD principal investigator
Wake Forest University Health Sciences
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AH-HA Tool in the EPIC EHR in people with Breast Neoplasm and Prostatic Neoplasm, run by Wake Forest University Health Sciences at 12 sites 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 4 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Patients Reporting Discussion of at Least One Non-ideal or Missing CVH Topic (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935282, which also lists 118 linked publications.
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 15 Apr 2026.