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

December 20, 2023 updated by: Wake Forest University Health Sciences

A Pilot Study to Examine 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathryn E Weaver, PhD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Other: 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.
Other: Survey
A brief survey before and after use of the tool will also be completed by participants.
Other: Interview Regarding Heart Health
Participants will be asked questions related to their heart health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants to Complete Heart Health Assessment - 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kathryn E Weaver, PhD, MPH, Wake Forest Baptist Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00095005
  • P30CA012197 (U.S. NIH Grant/Contract)
  • WFBCCC 99123 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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