Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors
Completed · Not applicable
Conditions studied: Breast Neoplasm, Prostatic Neoplasm, Colorectal Neoplasms, Endometrial Neoplasms, Hodgkin Disease, Non Hodgkin Lymphoma
In brief
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.
Key facts
- Study ID
- NCT03935282
- Run by
- Wake Forest University Health Sciences
- People needed
- 645
- Starts
- 2020-10-01
- Expected to finish
- 2025-11-17
- Last updated by the study team
- 2026-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- >= 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.
You may not qualify if…
- 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.
Where it is running
- Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
- Oncology Associates at Mercy Medical Center — Cedar Rapids, Iowa, United States
- Saint Louis Cancer and Breast Institute-Ballwin — Ballwin, Missouri, United States
- Mercy Hospital Springfield — Springfield, Missouri, United States
- Mercy Hospital Saint Louis — St Louis, Missouri, United States
- Mercy Hospital Oklahoma City — Oklahoma City, Oklahoma, United States
- Community Medical Center — Scranton, Pennsylvania, United States
- Geisinger Wyoming Valley/Henry Cancer Center — Wilkes-Barre, Pennsylvania, United States
- Baptist Memorial Hospital and Cancer Center-Memphis — Memphis, Tennessee, United States
- Baptist Memorial Hospital for Women — Memphis, Tennessee, United States
- Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States
- ThedaCare Regional Cancer Center — Appleton, Wisconsin, United States
Full record on ClinicalTrials.gov
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