Trial Outcomes & Findings for Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors (NCT NCT05796518)
NCT ID: NCT05796518
Last Updated: 2025-03-28
Results Overview
Feasibility will be defined from the number of participants who complete the web-based assessment using exact 95% binomial confidence intervals.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
6 months
Results posted on
2025-03-28
Participant Flow
Participant milestones
| Measure |
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).
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.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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).
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.
|
|---|---|
|
Overall Study
Were enrolled but did not complete the intervention
|
2
|
Baseline Characteristics
Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
Baseline characteristics by cohort
| Measure |
PREVENT - Cardiovascular Health Assessment Tool
n=42 Participants
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).
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.
|
|---|---|
|
Age, Continuous
|
61.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Out of the 44 participants enrolled only 42 complete the heart health assessment
Feasibility will be defined from the number of participants who complete the web-based assessment using exact 95% binomial confidence intervals.
Outcome measures
| Measure |
PREVENT - Cardiovascular Health Assessment Tool
n=44 Participants
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).
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.
|
|---|---|
|
Number of Participants to Complete Intervention - Feasibility
|
42 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPatient 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.
Outcome measures
| Measure |
PREVENT - Cardiovascular Health Assessment Tool
n=42 Participants
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).
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.
|
|---|---|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I am confident I understand my risk of heart disease · More Agreement
|
4 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I am confident I understand my risk of heart disease · No Change
|
36 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I am confident I understand my risk of heart disease · Less Agreement
|
1 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I am confident I understand my risk of heart disease · Missing
|
1 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I understand what steps I need to take to maintain or improve my heart health · More Agreement
|
7 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I understand what steps I need to take to maintain or improve my heart health · No Change
|
32 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I understand what steps I need to take to maintain or improve my heart health · Less Agreement
|
1 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I understand what steps I need to take to maintain or improve my heart health · Missing
|
2 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I plan to take steps to maintain or improve my heart health within the next year · More Agreement
|
5 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I plan to take steps to maintain or improve my heart health within the next year · No Change
|
34 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I plan to take steps to maintain or improve my heart health within the next year · Less Agreement
|
1 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I plan to take steps to maintain or improve my heart health within the next year · Missing
|
2 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
Cancer poses a risk to my health · More Agreement
|
6 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
Cancer poses a risk to my health · No Change
|
31 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
Cancer poses a risk to my health · Less Agreement
|
4 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
Cancer poses a risk to my health · Missing
|
1 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
Heart disease poses a risk to my health · More Agreement
|
8 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
Heart disease poses a risk to my health · No Change
|
22 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
Heart disease poses a risk to my health · Less Agreement
|
10 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
Heart disease poses a risk to my health · Missing
|
2 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I think it is important to talk to my oncology provider about heart health · More Agreement
|
7 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I think it is important to talk to my oncology provider about heart health · No Change
|
29 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I think it is important to talk to my oncology provider about heart health · Less Agreement
|
4 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I think it is important to talk to my oncology provider about heart health · Missing
|
2 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I think it is important to talk to my primary care provider about my heart health · More Agreement
|
4 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I think it is important to talk to my primary care provider about my heart health · No Change
|
26 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I think it is important to talk to my primary care provider about my heart health · Less Agreement
|
9 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
I think it is important to talk to my primary care provider about my heart health · Missing
|
3 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
Oncology providers should talk to their patients about their heart health · More Agreement
|
7 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
Oncology providers should talk to their patients about their heart health · No Change
|
29 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
Oncology providers should talk to their patients about their heart health · Less Agreement
|
3 Participants
|
|
Number of Participants Stating Satisfaction With PREVENT Tool
Oncology providers should talk to their patients about their heart health · Missing
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Not all participants completed reported data on the health assessment tool
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: 1\) 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
Outcome measures
| Measure |
PREVENT - Cardiovascular Health Assessment Tool
n=42 Participants
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).
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.
|
|---|---|
|
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Losing weight and maintaining a healthy body weight? · Yes
|
7 Participants
|
|
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Losing weight and maintaining a healthy body weight? · No
|
28 Participants
|
|
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Quitting smoking, or staying smoke-free? · Yes
|
0 Participants
|
|
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Quitting smoking, or staying smoke-free? · No
|
4 Participants
|
|
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Controlling your blood pressure? · Yes
|
11 Participants
|
|
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Controlling your blood pressure? · No
|
28 Participants
|
|
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Controlling your cholesterol? · Yes
|
7 Participants
|
|
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Controlling your cholesterol? · No
|
23 Participants
|
|
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Controlling your glucose or hemoglobin A1c? · Yes
|
9 Participants
|
|
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Controlling your glucose or hemoglobin A1c? · No
|
22 Participants
|
|
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Any discussion regarding health with health care providers · Yes
|
16 Participants
|
|
Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
Any discussion regarding health with health care providers · No
|
26 Participants
|
Adverse Events
PREVENT - Cardiovascular Health Assessment Tool
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Study Coordinator
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-713-0031
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place