Endometrial CancerNCT05796518
Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
A study testing PREVENT Cardiovascular Health Assessment Tool, Survey and Interview Regarding Heart Health in people with Endometrial Cancer and Survivorship, run by Wake Forest University Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Survivorship
- What is being tested?
- PREVENT Cardiovascular Health Assessment Tool, Survey and Interview Regarding Heart Health
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2023to 7 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study to Examine Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
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.
Read the 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.
- Conditions
- Endometrial Cancer, Survivorship
- Being tested
- PREVENT Cardiovascular Health Assessment Tool, Survey, Interview Regarding Heart Health
- Keywords
- Heart health
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREVENT Cardiovascular Health Assessment ToolOther
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.
SurveyOther
A brief survey before and after use of the tool will also be completed by participants.
Interview Regarding Heart HealthOther
Participants will be asked questions related to their heart health.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: PREVENT Cardiovascular Health Assessment Tool; Other: Survey; Other: Interview Regarding Heart Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
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. Participants responded yes/no to the following discussions:
- Losing weight and maintaining a healthy body weight? 2) Quitting smoking, or staying smoke-free? 3) Controlling your blood pressure? 4) Controlling your cholesterol? 5) Controlling your glucose or hemoglobin A1c? 6) Any discussion regarding health with health care providers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start7 Sep 2023
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Endometrial cancer survivors presenting for post-treatment surveillance visit.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathryn E Weaver, PhD, MPH, Principal investigator, Wake Forest Baptist Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796518
- Sponsor's protocol ID
- IRB00095005
- Other IDs
- WFBCCC 99123, P30CA012197
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2023
- Last updated
- 28 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Examine Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT05796518
- Acronym / sponsor ID
- IRB00095005
- Conditions
- Endometrial Cancer, Survivorship
- Keywords
- Heart health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Posted 28 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Endometrial cancer survivors presenting for post-treatment surveillance visit.
| Arm | Type | Receives |
|---|---|---|
| PREVENT - Cardiovascular Health Assessment Tool | Experimental | Other: PREVENT Cardiovascular Health Assessment Tool, Other: Survey, Other: Interview Regarding Heart HealthAn 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREVENT Cardiovascular Health Assessment ToolParticipants 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 | PREVENT - Cardiovascular Health Assessment Tool |
| SurveyA brief survey before and after use of the tool will also be completed by participants. | Other | PREVENT - Cardiovascular Health Assessment Tool |
| Interview Regarding Heart HealthParticipants will be asked questions related to their heart health. | Other | PREVENT - Cardiovascular Health Assessment Tool |
Primary outcome
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.
2 secondary outcomes
Number of Participants Stating Satisfaction With PREVENT Tool
Time frame: 6 months
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn E Weaver, PhD, MPH principal investigator
Wake Forest Baptist Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREVENT Cardiovascular Health Assessment Tool, Survey and Interview Regarding Heart Health in people with Endometrial Cancer and Survivorship, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants to Complete Intervention - Feasibility (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.