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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
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.
interventionNames
Other: AH-HA Tool in the EPIC EHR
type
NO_INTERVENTION
label
Usual Care
description
Usual care practices will conduct routine follow-up care visits for enrolled survivors following typical clinic practice, without use of the AH-HA tool.
Primary outcomes (1)
measure
Proportion of Patients Reporting Discussion of at Least One Non-ideal or Missing CVH Topic
timeFrame
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
Inclusion Criteria:
* \>= 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.
Exclusion Criteria:
* 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.
References
Publications (118)
BACKGROUNDShelburne 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. PMID 25210198
BACKGROUNDLajous 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. PMID 21158981
BACKGROUNDPatnaik 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. PMID 21689398
BACKGROUNDvan 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. PMID 24814358
BACKGROUNDWard 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. PMID 22507532
BACKGROUNDUnderwood 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.
Baseline
description
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.
Secondary outcomes (33)
measure
Referrals to Primary Care to Manage CV Risk
timeFrame
Baseline
description
Medical chart abstraction of referrals to providers regarding CVH at survivor baseline visit.
measure
Referrals to Cardiology to Manage CV Risk
timeFrame
Baseline
description
Medical chart abstraction of referrals to providers regarding CVH at survivor baseline visit.
measure
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Test
timeFrame
Baseline
description
Medical chart abstraction.
measure
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Glucose Test
timeFrame
Baseline
description
Medical chart abstraction.
measure
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: A1c Test
timeFrame
Baseline
description
Medical chart abstraction.
measure
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Medication
timeFrame
Baseline
description
Medical chart abstraction.
measure
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Diabetes Medication
timeFrame
Baseline
description
Medical chart abstraction.
measure
Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Blood Pressure Medication
timeFrame
Baseline
description
Medical chart abstraction.
measure
Any Completed Visits With Primary Care Providers
timeFrame
1 year
description
Medical chart abstraction of completed visits to providers regarding CVH one year from survivor baseline visit
measure
Any Completed Visits With Cardiology Providers
timeFrame
1 year
description
Medical chart abstraction of completed visits to providers regarding CVH one year from survivor baseline visit
measure
Change in CVH Behaviors Recorded in the Past Year: Smoking Status
timeFrame
1 year
description
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.
measure
Change in CVH Behaviors Recorded in the Past Year: BMI
timeFrame
1 year
description
Medical chart abstraction; Patient survey as secondary, verification source. Change in BMI from baseline to 1-year.
measure
Change in CVH Behaviors Recorded in the Past Year: Physical Activity
timeFrame
1 year
description
Medical chart abstraction; Patient survey as secondary, verification source. Change in total minutes of physical activity per week from baseline to 1-year.
measure
Change in CVH Behaviors Recorded in the Past Year: Healthy Diet Score
timeFrame
1 year
description
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.
measure
Change in CVH Factors Recorded in the Past Year: Total Cholesterol
timeFrame
1 year
description
Medical chart abstraction; Patient survey as secondary, verification source. Change in total cholesterol from baseline to 1-year.
measure
Change in CVH Factors Recorded in the Past Year: Systolic Blood Pressure
timeFrame
1 year
description
Medical chart abstraction; Patient survey as secondary, verification source. Change in systolic blood pressure l from baseline to 1-year.
measure
Change in CVH Factors Recorded in the Past Year: Diastolic Blood Pressure
timeFrame
1 year
description
Medical chart abstraction; Patient survey as secondary, verification source. Change in diastolic blood pressure l from baseline to 1-year.
measure
Change in CVH Factors Recorded in the Past Year: A1c
timeFrame
1 year
description
Medical chart abstraction; Patient survey as secondary, verification source. Change in A1c from baseline to 1-year.
measure
Change in CVH Factors Recorded in the Past Year: Glucose
timeFrame
1 year
description
Medical chart abstraction; Patient survey as secondary, verification source. Change in glucose from baseline to 1-year.
measure
Patient Perception and Knowledge of CV Risks: I am Confident I Understand my Risk of Heart Disease
timeFrame
Baseline
description
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.
measure
Patient Perception and Knowledge of CV Risks: I Understand What Steps I Need to Take to Maintain or Improve my Heart Health
timeFrame
Baseline
description
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.
measure
Patient Perception and Knowledge of CV Risks: I Plan to Take Steps to Maintain or Improve my Heart Health Within the Next Year
timeFrame
Baseline
description
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.
measure
Patient Perception and Knowledge of CV Risks: Cancer Poses a Risk to my Health
timeFrame
Baseline
description
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.
measure
Patient Perception and Knowledge of CV Risks: Heart Disease Poses a Risk to my Health
timeFrame
Baseline
description
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.
measure
Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Oncology Provider About my Heart Health
timeFrame
Baseline
description
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.
measure
Patient Perception and Knowledge of CV Risks: I Think it is Important to Talk to my Primary Care Provider About my Heart Health
timeFrame
Baseline
description
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.
measure
Patient Perception and Knowledge of CV Risks: Oncology Providers Should Talk to Their Patients About Their Heart Health
timeFrame
Baseline
description
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.
measure
Proportion of Survivors for Whom AH-HA is Utilized
timeFrame
Baseline
description
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.
measure
Measure of Tool Acceptability With Tool Assessment: I Liked the Heart Health Tool I Used Today With my Provider
timeFrame
Baseline
description
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.
measure
Measure of Tool Acceptability With Tool Assessment: It Was Helpful to See my Heart Health Score
timeFrame
Baseline
description
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.
measure
Measure of Tool Acceptability With Tool Assessment: I Found the Heart Health Tool Easy to Understand
timeFrame
Baseline
description
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.
measure
Measure of Tool Acceptability With Tool Assessment: The Picture/Diagram Improved my Understanding of Heart Health
timeFrame
Baseline
description
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.
measure
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
timeFrame
Baseline
description
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.
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DERIVEDNightingale CL, Dressler EV, Kepper M, Klepin HD, Lee SC, Smith S, Aguilar A, Wiseman KD, Sohl SJ, Wells BJ, DeMari JA, Throckmorton A, Kulbacki LW, Hanna J, Foraker RE, Weaver KE. Oncology Provider and Patient Perspectives on a Cardiovascular Health Assessment Tool Used During Posttreatment Survivorship Care in Community Oncology (Results from WF-1804CD): Mixed Methods Observational Study. J Med Internet Res. 2025 Mar 6;27:e65152. doi: 10.2196/65152. PMID 39854647
DERIVEDWeaver KE, Dressler EV, Klepin HD, Lee SC, Wells BJ, Smith S, Hundley WG, Lesser GJ, Nightingale CL, Turner JC, Lackey I, Heard K, Foraker R; AH-HA Study Team. Effectiveness of a Cardiovascular Health Electronic Health Record Application for Cancer Survivors in Community Oncology Practice: Results From WF-1804CD. J Clin Oncol. 2025 Jan;43(1):46-56. doi: 10.1200/JCO.24.00342. Epub 2024 Nov 21. PMID 39571113
DERIVEDWeaver KE, Dressler EV, Smith S, Nightingale CL, Klepin HD, Lee SC, Wells BJ, Hundley WG, DeMari JA, Price SN, Foraker RE. Cardiovascular health assessment in routine cancer follow-up in community settings: survivor risk awareness and perspectives. BMC Cancer. 2024 Jan 31;24(1):158. doi: 10.1186/s12885-024-11912-8. PMID 38297229
DERIVEDDeMari JA, Dressler EV, Foraker RE, Wells BJ, Smith S, Klepin H, Hundley WG, Lesser GJ, Shalowitz DI, Nightingale CL, Hernandez M, Weaver KE. Endometrial cancer survivors' perceptions of their cardiovascular disease risk (results from WF-1804CD AH-HA). Gynecol Oncol. 2023 Jul;174:208-212. doi: 10.1016/j.ygyno.2023.05.009. Epub 2023 May 22. PMID 37224793