Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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To assess patient satisfaction with the tool.
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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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants to Complete Heart Health Assessment - Feasibility [6 months]
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 [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.
- Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health with Health Care Providers [6 months]
The initiation of discussions with participants' health care providers will largely be descriptive (using means as a measurement) to analyze this measure
Eligibility Criteria
Criteria
Inclusion Criteria:
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Scheduled for a routine surveillance visit for pathologically confirmed stages I-IV endometrial cancer
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Greater than or equal to 3 months post-potentially curative cancer treatment
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Patients must be at least 18 years of age
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Have a working email address
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Comfortable reading medical information in English, as per self-report
Exclusion Criteria:
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Currently receiving treatment (e.g. radiation, chemotherapy, immunological treatments for endometrial cancer)
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Have a history of endometrial cancer recurrence
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Enrolled in hospice care or documentation of life expectancy < 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Kathryn E Weaver, PhD, MPH, Wake Forest Baptist Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00095005
- WFBCCC 99123
- P30CA012197