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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05796518
• Other study ID #: IRB00095005
• Secondary ID: WFBCCC 99123P30C
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Survivorship

Intervention

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.
• Survey
A brief survey before and after use of the tool will also be completed by participants.
• Interview Regarding Heart Health
Participants will be asked questions related to their heart health.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants to Complete Heart Health Assessment - Feasibility	Feasibility will be defined from the number of participants who complete the web-based assessment using exact 95% binomial confidence intervals.	6 months
Secondary	Number of Participants Stating Satisfaction with PREVENT Tool	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
Secondary	Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health with Health Care Providers	The initiation of discussions with participants' health care providers will largely be descriptive (using means as a measurement) to analyze this measure	6 months