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

NCT05796518 | Completed Results DMC

• 3 other identifiers: IRB00095005WFBCCC 99123P30CA012197
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer; Survivorship

Keywords

Heart health

Outcome Measures

Primary Outcomes (1)

• Number of Participants to Complete Intervention - 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 Outcomes (2)

• 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 Arms (1)

PREVENT - Cardiovascular Health Assessment Tool

EXPERIMENTAL

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; Other: Survey; Other: Interview Regarding Heart Health

Interventions

PREVENT Cardiovascular Health Assessment Tool OTHER

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.

PREVENT - Cardiovascular Health Assessment Tool

Survey OTHER

A brief survey before and after use of the tool will also be completed by participants.

PREVENT - Cardiovascular Health Assessment Tool

Interview Regarding Heart Health OTHER

Participants will be asked questions related to their heart health.

PREVENT - Cardiovascular Health Assessment Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Study Coordinator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

mnjenkin@wakehealth.edu

336-713-0031

Study Officials

• Kathryn E Weaver, PhD, MPH

  Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Endometrial cancer survivors presenting for post-treatment surveillance visit.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: September 7, 2023
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)