Ignite Creation Date:
2025-12-25 @ 4:45 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT05796518
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2023-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mnjenkin@wakehealth.edu', 'phone': '336-713-0031', 'title': 'Study Coordinator', 'organization': 'Wake Forest Baptist Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 3 months after using study tool', 'eventGroups': [{'id': 'EG000', 'title': 'PREVENT - Cardiovascular Health Assessment Tool', 'description': '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).\n\nPREVENT 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.\n\nSurvey: A brief survey before and after use of the tool will also be completed by participants.\n\nInterview Regarding Heart Health: Participants will be asked questions related to their heart health.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants to Complete Intervention - Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PREVENT - Cardiovascular Health Assessment Tool', 'description': '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).\n\nPREVENT 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.\n\nSurvey: A brief survey before and after use of the tool will also be completed by participants.\n\nInterview Regarding Heart Health: Participants will be asked questions related to their heart health.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Feasibility will be defined from the number of participants who complete the web-based assessment using exact 95% binomial confidence intervals.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of the 44 participants enrolled only 42 complete the heart health assessment'}, {'type': 'SECONDARY', 'title': 'Number of Participants Stating Satisfaction With PREVENT Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PREVENT - Cardiovascular Health Assessment Tool', 'description': '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).\n\nPREVENT 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.\n\nSurvey: A brief survey before and after use of the tool will also be completed by participants.\n\nInterview Regarding Heart Health: Participants will be asked questions related to their heart health.'}], 'classes': [{'title': 'I am confident I understand my risk of heart disease', 'categories': [{'title': 'More Agreement', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Less Agreement', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'I understand what steps I need to take to maintain or improve my heart health', 'categories': [{'title': 'More Agreement', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'Less Agreement', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'I plan to take steps to maintain or improve my heart health within the next year', 'categories': [{'title': 'More Agreement', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '34', 'groupId': 'OG000'}]}, {'title': 'Less Agreement', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Cancer poses a risk to my health', 'categories': [{'title': 'More Agreement', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': 'Less Agreement', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Heart disease poses a risk to my health', 'categories': [{'title': 'More Agreement', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Less Agreement', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'I think it is important to talk to my oncology provider about heart health', 'categories': [{'title': 'More Agreement', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Less Agreement', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'I think it is important to talk to my primary care provider about my heart health', 'categories': [{'title': 'More Agreement', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Less Agreement', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Oncology providers should talk to their patients about their heart health', 'categories': [{'title': 'More Agreement', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Less Agreement', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': "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.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PREVENT - Cardiovascular Health Assessment Tool', 'description': '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).\n\nPREVENT 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.\n\nSurvey: A brief survey before and after use of the tool will also be completed by participants.\n\nInterview Regarding Heart Health: Participants will be asked questions related to their heart health.'}], 'classes': [{'title': 'Losing weight and maintaining a healthy body weight?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Quitting smoking, or staying smoke-free?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Controlling your blood pressure?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Controlling your cholesterol?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Controlling your glucose or hemoglobin A1c?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Any discussion regarding health with health care providers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': "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:\n\n1\\) 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", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants completed reported data on the health assessment tool'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PREVENT - Cardiovascular Health Assessment Tool', 'description': '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).\n\nPREVENT 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.\n\nSurvey: A brief survey before and after use of the tool will also be completed by participants.\n\nInterview Regarding Heart Health: Participants will be asked questions related to their heart health.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Were enrolled but did not complete the intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PREVENT - Cardiovascular Health Assessment Tool', 'description': '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).\n\nPREVENT 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.\n\nSurvey: A brief survey before and after use of the tool will also be completed by participants.\n\nInterview Regarding Heart Health: Participants will be asked questions related to their heart health.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'groupId': 'BG000', 'lowerLimit': '56.0', 'upperLimit': '66.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-11', 'size': 394109, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-20T15:35', 'hasProtocol': True}, {'date': '2023-07-11', 'size': 197787, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-02T14:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Endometrial cancer survivors presenting for post-treatment surveillance visit.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2023-03-21', 'resultsFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-11', 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants to Complete Intervention - Feasibility', 'timeFrame': '6 months', 'description': 'Feasibility will be defined from the number of participants who complete the web-based assessment using exact 95% binomial confidence intervals.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Stating Satisfaction With PREVENT Tool', 'timeFrame': '6 months', 'description': "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."}, {'measure': 'Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers', 'timeFrame': '6 months', 'description': "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:\n\n1\\) 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"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart health'], 'conditions': ['Endometrial Cancer', 'Survivorship']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nSecondary Objectives:\n\n* To assess patient satisfaction with the tool.\n* To identify the proportion of patients with non-ideal cardiovascular health scores who report initiating discussions regarding cardiovascular health during their routine oncology appointment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for a routine surveillance visit for pathologically confirmed stages I-IV endometrial cancer\n* Greater than or equal to 3 months post-potentially curative cancer treatment\n* Patients must be at least 18 years of age\n* Have a working email address\n* Comfortable reading medical information in English, as per self-report\n\nExclusion Criteria:\n\n* Currently receiving treatment (e.g. radiation, chemotherapy, immunological treatments for endometrial cancer)\n* Have a history of endometrial cancer recurrence\n* Enrolled in hospice care or documentation of life expectancy \\< 6 months'}, 'identificationModule': {'nctId': 'NCT05796518', 'briefTitle': 'Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Pilot Study to Examine Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors', 'orgStudyIdInfo': {'id': 'IRB00095005'}, 'secondaryIdInfos': [{'id': 'WFBCCC 99123', 'type': 'OTHER', 'domain': 'Wake Forest Baptist Comprehensive Cancer Center'}, {'id': 'P30CA012197', 'link': 'https://reporter.nih.gov/quickSearch/P30CA012197', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PREVENT - Cardiovascular Health Assessment Tool', 'description': '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).', 'interventionNames': ['Other: PREVENT Cardiovascular Health Assessment Tool', 'Other: Survey', 'Other: Interview Regarding Heart Health']}], 'interventions': [{'name': 'PREVENT Cardiovascular Health Assessment Tool', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['PREVENT - Cardiovascular Health Assessment Tool']}, {'name': 'Survey', 'type': 'OTHER', 'description': 'A brief survey before and after use of the tool will also be completed by participants.', 'armGroupLabels': ['PREVENT - Cardiovascular Health Assessment Tool']}, {'name': 'Interview Regarding Heart Health', 'type': 'OTHER', 'description': 'Participants will be asked questions related to their heart health.', 'armGroupLabels': ['PREVENT - Cardiovascular Health Assessment Tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Comprehensive Cancer Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Kathryn E Weaver, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest Baptist Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}