NCT03935282

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
645

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2025

Completed
5 months until next milestone

Results Posted

Study results publicly available

April 15, 2026

Completed
Last Updated

April 15, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

April 11, 2019

Results QC Date

January 29, 2026

Last Update Submit

April 2, 2026

Conditions

Keywords

Cardiovascular riskCardiovascular diseaseCancerSurvivorHealth BehaviorsOncology ProvidersEHRInformatics

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (33)

  • Referrals to Primary Care to Manage CV Risk

    Baseline

  • Referrals to Cardiology to Manage CV Risk

    Baseline

  • Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Cholesterol Test

    Baseline

  • Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: Glucose Test

    Baseline

  • Ordering of CVH-relevant Labs and Treatments to Manage CV Risk: A1c Test

    Baseline

  • +28 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

The Automated Heart-Health Assessment tool implemented in clinics' EPIC EHR will be used by providers during routine follow-up care appointments.

Intervention - AH-HA tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States

Location

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, 63011, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

Location

Community Medical Center

Scranton, Pennsylvania, 18510, United States

Location

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States

Location

Baptist Memorial Hospital for Women

Memphis, Tennessee, 38120, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

Location

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  • Weaver 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.

  • Weaver 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.

  • DeMari 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.

MeSH Terms

Conditions

Breast NeoplasmsProstatic NeoplasmsColorectal NeoplasmsEndometrial NeoplasmsHodgkin DiseaseLymphoma, Non-HodgkinCardiovascular DiseasesNeoplasmsHealth Behavior

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehavior

Results Point of Contact

Title
Emily Dressler
Organization
NCORP

Study Officials

  • Kathryn Weaver, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2019

First Posted

May 2, 2019

Study Start

October 1, 2020

Primary Completion

March 7, 2025

Study Completion

November 17, 2025

Last Updated

April 15, 2026

Results First Posted

April 15, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Time Frame
6 months after publication for a 2 year duration.
Access Criteria
upon request to NCORP@wakehealth.edu

Locations