Skip to main content
OpenTrials
Completed

NCT Number: NCT05796518

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Survivorship Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PREVENT Cardiovascular Health Assessment Tool

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

Other

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

Interview Regarding Heart Health

Other

Participants will be asked questions related to their heart health.

Primary outcomes

  1. Number of Participants to Complete Intervention - Feasibility

    Time frame: 6 months

    Feasibility will be defined from the number of participants who complete the web-based assessment using exact 95% binomial confidence intervals.

Secondary outcomes

  1. Number of Participants Stating Satisfaction With PREVENT Tool

    Time frame: 6 months

    Patient satisfaction will be identified through post-visit survey with a 5-point Likert scale (strongly agree to strongly disagree) regarding liking the tool, helpfulness, ease of understanding and desire to use this tool with their oncologist. One-sample t-tests will be used to test whether the average response to each question is greater than 3.5 (with three denoting a neutral response). Wilcoxon signed rank tests will be used to compare cancer survivors' knowledge regarding their cardiovascular health risk factors and perceived importance of cancer and heart disease before and after using the cardiovascular risk visualization tool.

  2. Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers

    Time frame: 6 months

    The initiation of discussions with participants' health care providers will largely be descriptive (using means as a measurement) to analyze this measure. Participants responded yes/no to the following discussions:

    • Losing weight and maintaining a healthy body weight? 2) Quitting smoking, or staying smoke-free? 3) Controlling your blood pressure? 4) Controlling your cholesterol? 5) Controlling your glucose or hemoglobin A1c? 6) Any discussion regarding health with health care providers

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Study to Examine Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2023
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.