Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors

NCT ID: NCT05796518

Last Updated: 2025-03-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-07

Study Completion Date

2024-06-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Investigators are conducting this study to find out more about what heart health means to participants and how healthcare providers can best help to manage heart health. Participants will be asked to view an electronic tool designed to promote heart health awareness and help to manage heart health outside of the clinic. This study will provide important information to help investigators develop future programs that improve cancer patient's heart health after they complete their treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary Objective: The primary objective of this pilot study is to assess the feasibility of enrolling and completing the heart health assessment among endometrial cancer patients scheduled for routine follow-up care.

Secondary Objectives:

* To assess patient satisfaction with the tool.
* To identify the proportion of patients with non-ideal cardiovascular health scores who report initiating discussions regarding cardiovascular health during their routine oncology appointment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometrial Cancer Survivorship

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Endometrial cancer survivors presenting for post-treatment surveillance visit.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PREVENT - Cardiovascular Health Assessment Tool

An adapted version of the PREVENT tool for endometrial cancer survivors will be used collect data during routine follow-up care for endometrial cancer that will yield a cardiovascular health score based on the Simple 7 risk factors (current smoking habits, body mass index, physical activity, diet, cholesterol, blood pressure and fasting plasma glucose).

Group Type EXPERIMENTAL

PREVENT Cardiovascular Health Assessment Tool

Intervention Type OTHER

Participants will access a heart health information visualization tool online using a personal device or a study tablet computer using their e-mail address to log-in. Investigators will review participant lab results specifically related to their cardiovascular health (e.g. blood pressure, cholesterol) in order to personalize the heart health tool for participants. A brief survey before and after use of the tool will also be completed by participants.

Survey

Intervention Type OTHER

A brief survey before and after use of the tool will also be completed by participants.

Interview Regarding Heart Health

Intervention Type OTHER

Participants will be asked questions related to their heart health.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PREVENT Cardiovascular Health Assessment Tool

Participants will access a heart health information visualization tool online using a personal device or a study tablet computer using their e-mail address to log-in. Investigators will review participant lab results specifically related to their cardiovascular health (e.g. blood pressure, cholesterol) in order to personalize the heart health tool for participants. A brief survey before and after use of the tool will also be completed by participants.

Intervention Type OTHER

Survey

A brief survey before and after use of the tool will also be completed by participants.

Intervention Type OTHER

Interview Regarding Heart Health

Participants will be asked questions related to their heart health.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Scheduled for a routine surveillance visit for pathologically confirmed stages I-IV endometrial cancer
* Greater than or equal to 3 months post-potentially curative cancer treatment
* Patients must be at least 18 years of age
* Have a working email address
* Comfortable reading medical information in English, as per self-report

Exclusion Criteria

* Currently receiving treatment (e.g. radiation, chemotherapy, immunological treatments for endometrial cancer)
* Have a history of endometrial cancer recurrence
* Enrolled in hospice care or documentation of life expectancy \< 6 months
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kathryn E Weaver, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Comprehensive Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WFBCCC 99123

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00095005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pain in Cancer Survivors
NCT00581724 COMPLETED
Expanding Rural Health Cancer Control Capacity
NCT04765072 ACTIVE_NOT_RECRUITING NA