Back to resultsFeasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
Primary Purpose
Endometrial Cancer, Survivorship
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PREVENT Cardiovascular Health Assessment Tool
Survey
Interview Regarding Heart Health
Sponsored by
About this trial
This is an interventional supportive care trial for Endometrial Cancer focused on measuring Heart health
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
Sites / Locations
- Wake Forest Baptist Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PREVENT - Cardiovascular Health Assessment Tool
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT05796518
First Posted
March 21, 2023
Last Updated
September 11, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05796518
Brief Title
Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
Official Title
A Pilot Study to Examine Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Survivorship
Keywords
Heart health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Endometrial cancer survivors presenting for post-treatment surveillance visit.
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PREVENT - Cardiovascular Health Assessment Tool
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
PREVENT Cardiovascular Health Assessment Tool
Intervention Description
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
Intervention Name(s)
Survey
Intervention Description
A brief survey before and after use of the tool will also be completed by participants.
Intervention Type
Other
Intervention Name(s)
Interview Regarding Heart Health
Intervention Description
Participants will be asked questions related to their heart health.
Primary Outcome Measure Information:
Title
Number of Participants to Complete Heart Health Assessment - Feasibility
Description
Feasibility will be defined from the number of participants who complete the web-based assessment using exact 95% binomial confidence intervals.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants Stating Satisfaction with PREVENT Tool
Description
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.
Time Frame
6 months
Title
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health with Health Care Providers
Description
The initiation of discussions with participants' health care providers will largely be descriptive (using means as a measurement) to analyze this measure
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
336-713-0031
Email
mnjenkin@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn E Weaver, PhD, MPH
Organizational Affiliation
Wake Forest Baptist Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
336-713-0031
Email
mnjenkin@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Kathryn E Weaver, PhD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
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