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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 99123 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn E Weaver, PhD, MPH | Wake Forest Baptist Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Out of the 44 participants enrolled only 42 complete the heart health assessment | Posted | Count of Participants | Participants | 6 months |
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up to 3 months after using study tool
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Wake Forest Baptist Comprehensive Cancer Center | 336-713-0031 | mnjenkin@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2023 | Feb 20, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 11, 2023 | Aug 2, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Endometrial cancer survivors presenting for post-treatment surveillance visit.
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| Survey | Other | A brief survey before and after use of the tool will also be completed by participants. |
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| Interview Regarding Heart Health | Other | Participants will be asked questions related to their heart health. |
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| 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: 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 | 6 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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 | Not all participants completed reported data on the health assessment tool | Posted | Count of Participants | Participants | 6 months |
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| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
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| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Missing |
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| I understand what steps I need to take to maintain or improve my heart health |
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| I plan to take steps to maintain or improve my heart health within the next year |
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| Cancer poses a risk to my health |
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| Heart disease poses a risk to my health |
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| I think it is important to talk to my oncology provider about heart health |
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| I think it is important to talk to my primary care provider about my heart health |
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| Oncology providers should talk to their patients about their heart health |
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| Quitting smoking, or staying smoke-free? |
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| Controlling your blood pressure? |
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| Controlling your cholesterol? |
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| Controlling your glucose or hemoglobin A1c? |
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| Any discussion regarding health with health care providers |
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