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Clinical Trials/NCT05796518
NCT05796518
Completed
Not Applicable

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

Wake Forest University Health Sciences1 site in 1 country44 target enrollmentSeptember 7, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometrial Cancer
Sponsor
Wake Forest University Health Sciences
Enrollment
44
Locations
1
Primary Endpoint
Number of Participants to Complete Intervention - Feasibility
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 7, 2023
End Date
June 7, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Number of Participants Stating Satisfaction With PREVENT Tool(6 months)
  • Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers(6 months)

Study Sites (1)

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