[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638028":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":34,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":23,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":23,"enrollmentInfo":65,"targetDuration":23,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":23,"overallStatus":74,"whyStopped":23,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patient-Caregiver","EXPERIMENTAL","This arm includes participants with gynecologic malignancies who identify and enroll with a caregiver. Both participants and caregivers will complete baseline, 3-month, and 6-month assessments. Caregiver distress and NMDOH needs will be evaluated at baseline, and results will be used to guide the provision of Community Resource Navigation (CRN).",[13],"Other: Surveys",{"label":15,"type":10,"description":16,"interventionNames":17},"Patient Without a Caregivers","This arm includes patients with gynecologic malignancies who do not identify or enroll with a caregiver. These participants will complete the same assessment timepoints (baseline, 3 months, and 6 months). Data from this group will serve as a comparison to evaluate differences in outcomes relative to patients with caregivers, including the impact of caregiver presence, distress levels, and NMDOH burden.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Surveys","Study surveys will be administered primarily in REDCap, or with the help of a coordinator (i.e. mailing surveys, over the phone, or with a tablet during clinic visits) if assistance is needed.",[15,9],null,[25],{"name":26,"affiliation":27,"role":28},"Abigail Smith Zamorano, MD","UT MD Anderson","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":23,"email":33},"CONTACT","713-792-9938","aszamorano@mdanderson.org",[35],{"facility":27,"status":23,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Houston","Texas","77030","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-95.36327,29.76328,{"lat":45,"lon":44},[48,49],{"name":26,"role":31,"phone":32,"phoneExt":23,"email":33},{"name":26,"role":28,"phone":23,"phoneExt":23,"email":23},{"type":51,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[53],{"name":54,"class":55},"Ovarian Cancer Research Alliance (OCRA)","UNKNOWN","100638028","ocra-distress--unmet-needs-100638028",false,"NCT07591623","OCRA Distress & Unmet Needs","Identifying And Addressing Distress And Unmet Needs Of Gynecologic Cancer Caregivers","Inclusion Criteria:\n\nThis study will include participants from two categories:\n\nPatients:\n\n1. Must be at least 18 years old\n2. Must read and speak English or Spanish\n3. Participants must have access to the internet via a smartphone, tablet, or computer (public or private), or have reliable access to a telephone to communicate with the study coordinator.\n4. Patient presenting for initial or recurrence chemotherapy treatment for management of a gynecologic malignancy (cancer of the ovary, uterus, cervix, vulva, vagina, peritoneum, or fallopian tube)\n5. No physical, psychological, or cognitive impairments that would preclude participation and ability to understand the consent statement\n\nCaregivers:\n\n1. Must be at least 18 years old\n2. Must read and speak English or Spanish\n3. Participants must have access to the internet via a smartphone, tablet, or computer (public or private), or have reliable access to a telephone to communicate with the study coordinator.\n4. Must be an identified caregiver of an enrolled patient\n5. No physical, psychological, or cognitive impairments that would preclude participation and ability to understand the consent statement\n\nThe study will include patients with no caregiver, and only one caregiver may enroll per patient.\n\nExclusion Criteria:\n\nPatients:\n\n1\\. Unwilling or unable to proceed beyond the consent statement step Caregivers\n\n1\\. Unwilling or unable to proceed beyond the consent statement step","ALL","18 Years",{"count":66,"type":67},250,"ESTIMATED","INTERVENTIONAL",[70],"NA","This study is a prospective longitudinal cohort study with an embedded intervention. It follows participants with gynecologic malignancies and their informal caregivers over a 6-month period to assess caregiver distress, NMDOH, and patient outcomes.",[73],"Gynecologic Cancer","NOT_YET_RECRUITING","2026-05-13",{"date":77,"type":78},"2026-05-18","ACTUAL",{"date":80,"type":67},"2026-10-01",{"date":82,"type":67},"2029-03-31",{"name":5,"class":6},1]