AH-HA EHR Tool for Heart Health in Cancer Survivors

(AH-HA Trial)

Not currently recruiting at 12 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Cancer recurrence, Active surveillance, Language barrier, Other protocol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, called AH-HA, added to electronic health records (EHR) to facilitate discussions about heart health between cancer survivors and their doctors. It aims to improve heart health conversations and encourage visits to primary care or heart specialists among survivors of breast, prostate, colorectal, endometrial, or certain types of lymphoma. Individuals at least six months past cancer treatment, with no current signs of the disease except for non-melanoma skin cancer, might be suitable candidates. The study involves two groups: one uses the AH-HA tool during routine follow-up visits, while the other receives usual care without the tool. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance survivorship care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, ongoing hormonal therapies like tamoxifen or aromatase inhibitors are allowed.

What prior data suggests that the AH-HA tool is safe for cancer survivors?

Research shows that the AH-HA tool, integrated into the EPIC electronic health record system, is well-liked by both patients and healthcare providers. Previous studies found that this tool increases discussions about heart health during follow-up visits for cancer survivors. Importantly, no reports have indicated any problems or safety issues with using this tool. This suggests it is safe for use in healthcare settings to encourage conversations about heart health among cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AH-HA tool because it aims to improve heart health management in cancer survivors by integrating directly into the EPIC electronic health record (EHR) system. Unlike standard follow-up care, which relies on traditional methods and practices, this tool offers a streamlined process for healthcare providers to access and utilize heart health data during routine appointments. This integration could potentially lead to more personalized and efficient care, helping to address the unique cardiovascular risks that cancer survivors face. By enhancing how data is used in real-time, the AH-HA tool could set a new standard in preventive care for this vulnerable group.

What evidence suggests that the AH-HA tool is effective for improving heart health in cancer survivors?

Research shows that the AH-HA tool, which participants in this trial may receive, can improve heart health by encouraging cancer survivors to discuss heart issues with their doctors. Studies have found that this tool prompts doctors to recommend visits to primary care doctors and specialists, which is crucial for better heart care. The AH-HA tool is based on the American Heart Association's guidelines, Life's Simple 7, which aim to improve heart health habits. Early results suggest that using this tool leads to more health-promoting actions and reduces the risk of heart disease for cancer survivors. Overall, evidence supports the effectiveness of the AH-HA tool in enhancing heart health discussions and care coordination. ^{1 6 7 8 9}

Who Is on the Research Team?

Kathryn Weaver, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are cancer survivors (specifically of breast, prostate, colorectal, endometrial cancers or Hodgkin and non-Hodgkin lymphomas) with no current evidence of disease. They must understand English or Spanish, consent verbally to participate, be able to complete a follow-up in one year and have finished curative treatment at least 6 months ago.

Inclusion Criteria

Able and willing to complete a follow-up assessment in one year.

I have a cancer follow-up visit within 30 days with an AH-HA trained provider.

It's been over 6 months since my last cancer treatment, but I may still be on hormone therapy.

Exclusion Criteria

I have not had a cancer recurrence except for non-melanoma skin cancer.

You are currently participating in another study that focuses on improving heart health through factors like blood pressure, smoking, diet, and physical activity.

I am not on active surveillance for prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants provide baseline data before and immediately after seeing their oncology provider

1 week

1 visit (in-person)

Intervention

Providers at intervention sites are trained to use the AH-HA tool during routine follow-up care with survivors

1 year

Routine follow-up visits

Follow-up

Participants complete 6-month and 1-year study follow-up visits to assess changes in cardiovascular health outcomes

1 year

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AH-HA Tool in the EPIC EHR

Trial Overview The study tests an electronic health record tool called AH-HA designed to improve heart health discussions between patients and doctors. It will also look at whether the tool helps increase referrals to primary care/cardiology and promotes activities that reduce cardiovascular risk among cancer survivors.

How Is the Trial Designed?

Group I: Intervention - AH-HA tool Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 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 Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

The pilot study involving 23 female breast cancer survivors demonstrated that an app-based interactive care plan (ICP) was feasible, allowing for remote monitoring and symptom management, although patient engagement fell short of the desired 75% completion rate for tasks.

Despite the initial feasibility, with all patients engaging in at least one task, the decreasing completion rates over time indicate a need for strategies to improve ongoing patient engagement and enhance the effectiveness of the ICP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot implementation to assess the feasibility and care team impact of an app-based interactive care plan to remotely monitor breast cancer survivors. Stan, DL., Inselman, JW., Ridgeway, JL., et al.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.12019

Effectiveness of the Automated Heart-Health Assessment ... The AH-HA tool, based on the American Heart Association (AHA) Life's Simple 7, aimed to enhance CVH awareness and action by providers and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39571113/

Effectiveness of a Cardiovascular Health Electronic ... - PubMed The AH-HA tool was effective at promoting CVH discussions during routine follow-up care for survivors and recommendations to consult primary care.

3. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2025.43.16_suppl.12019

12-month results from WF-1804CD. Effectiveness of the Automated Heart-Health Assessment (AH-HA) tool on cardiovascular health improvements among post-treatment cancer survivors: ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8220316/

Addressing cancer survivors' cardiovascular health using ... The purpose of this paper is to describe the Automated Heart-Health Assessment (AH-HA) study protocol, which demonstrates an agile approach ...

5. profiles.wustl.edu profiles.wustl.edu/en/publications/effectiveness-of-a-cardiovascular-health-electronic-health-record

Effectiveness of a Cardiovascular Health Electronic ... CONCLUSION The AH-HA tool was effective at promoting CVH discussions during routine follow-up care for survivors and recommendations to consult primary care. AB ...

6. ascopubs.org ascopubs.org/doi/10.1200/OP.2023.19.11_suppl.423

Acceptability of the AH-HA cardiovascular health ... The AH-HA tool was acceptable to both patients and providers when used to promote CVH discussions during follow-up care for survivors.

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.17_suppl.LBA12007

Effectiveness of a cardiovascular health EHR application ... The AH-HA tool was acceptable and effective at promoting CVH discussions during routine follow-up care for survivors and referrals to primary care.

8. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct03935282

Assessing Effectiveness and Implementation of an EHR Tool ... Our central hypothesis is that the AH-HA tool will increase (1) cardiovascular health (CVH) discussions among survivors and oncology providers, (2) referrals ...

9. researchgate.net researchgate.net/publication/386021505_Effectiveness_of_a_Cardiovascular_Health_Electronic_Health_Record_Application_for_Cancer_Survivors_in_Community_Oncology_Practice_Results_From_WF-1804CD

Results From WF-1804CD - cancer survivors This study evaluated the automated heart-health assessment (AH-HA) clinical decision support tool to promote provider-patient CV health (CVH) discussions in ...