Endometrial Cancer, Survivorship
Conditions
Keywords
Heart health
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.
Interventions
OTHERPREVENT 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.
OTHERSurvey
A brief survey before and after use of the tool will also be completed by participants.
OTHERInterview Regarding Heart Health
Participants will be asked questions related to their heart health.
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Endometrial cancer survivors presenting for post-treatment surveillance visit.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants to Complete Intervention - 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
| Measure | Time frame | Description |
|---|---|---|
| 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. 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Were enrolled but did not complete the intervention | 2 |
Baseline characteristics
| Characteristic | PREVENT - Cardiovascular Health Assessment Tool |
|---|---|
| Age, Continuous | 61.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
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.
Time frame: 6 months
Population: Out of the 44 participants enrolled only 42 complete the heart health assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants to Complete Intervention - Feasibility | 42 Participants |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | I am confident I understand my risk of heart disease | More Agreement | 4 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | I am confident I understand my risk of heart disease | No Change | 36 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | I am confident I understand my risk of heart disease | Less Agreement | 1 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | I am confident I understand my risk of heart disease | Missing | 1 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | Cancer poses a risk to my health | More Agreement | 6 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | Cancer poses a risk to my health | No Change | 31 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | Cancer poses a risk to my health | Less Agreement | 4 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | Cancer poses a risk to my health | Missing | 1 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | Heart disease poses a risk to my health | More Agreement | 8 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | Heart disease poses a risk to my health | No Change | 22 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | Heart disease poses a risk to my health | Less Agreement | 10 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | Heart disease poses a risk to my health | Missing | 2 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | Oncology providers should talk to their patients about their heart health | More Agreement | 7 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | Oncology providers should talk to their patients about their heart health | No Change | 29 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | Oncology providers should talk to their patients about their heart health | Less Agreement | 3 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants Stating Satisfaction With PREVENT Tool | Oncology providers should talk to their patients about their heart health | Missing | 3 Participants |
Secondary
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: 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
Time frame: 6 months
Population: Not all participants completed reported data on the health assessment tool
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers | Quitting smoking, or staying smoke-free? | Yes | 0 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers | Quitting smoking, or staying smoke-free? | No | 4 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers | Controlling your blood pressure? | Yes | 11 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers | Controlling your blood pressure? | No | 28 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers | Controlling your cholesterol? | Yes | 7 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers | Controlling your cholesterol? | No | 23 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers | Controlling your glucose or hemoglobin A1c? | Yes | 9 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers | Controlling your glucose or hemoglobin A1c? | No | 22 Participants |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |
| PREVENT - Cardiovascular Health Assessment Tool | 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 |