[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iii-vulvar-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iii-vulvar-cancer-ajcc-v8":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100650009","a-blended-e-health-intervention-to-improve-fear-of-progression-in-women-with-gynecologic-or-breast-cancer-100650009",false,"NCT07741968","A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer","An e-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer","Inclusion Criteria:\n\n* Women with stage III or IV GYN (ovarian, endometrial, cervical, vulvar\u002Fvaginal) or breast cancer who are at least 2 months from initial diagnosis OR Women with stage I or II endometrial, ovarian, or breast cancer with carcinosarcoma histology OR Women with stage I or II triple negative breast cancer\n* Score ≥ 34 on the Fear of Progression Short-Form, indicating dysfunctional levels\n* Age 18 or older; able to read and understand English\n* Patients can be on active treatment or surveillance. They can be no evidence of disease (NED), recurrent or with progressive disease\n\nExclusion Criteria:\n\n* Enrolled in hospice\n* Ongoing uncontrolled active psychiatric condition that, in the opinion of the investigator, would interfere in the conduct of the study (e.g., mood disorders, psychosis disorders, or substance use), Major depression as assessed by Patient Health Questionnaire-9 (PHQ-9)\n* Non-English speaking\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)\n* Current participation in a mind-body or mindfulness education program within the past six weeks","FEMALE","18 Years",{"count":19,"type":20},126,"ESTIMATED","INTERVENTIONAL",[23],"NA","This clinical trial studies whether an intervention supported by technology (blended e-health intervention) works to improve fear of progression (FOP) in women with gynecologic or breast cancer. FOP is the fear patients experience from the possibility that their cancer could grow, spread, or get worse. Managing FOP is a leading unmet concern of cancer patients. High levels of FOP are associated with distress, depression, and increased health care costs, despite this, access to resources to address FOP remain limited. The blended e-health intervention in this trial offers remote group sessions along with online sessions to help patients access the information. Session content incorporates values-based goal setting and skills practices to manage unhelpful beliefs about worry and promote helpful coping behaviors. The sessions may help patients recognize unhelpful thoughts and behaviors which reinforce worry. A blended e-health intervention may be an effective way to improve FOP in women with gynecologic or breast cancer.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Breast Carcinoma","Breast Mixed Epithelial\u002FMesenchymal Metaplastic Carcinoma","Endometrial Carcinoma","Malignant Female Reproductive System Neoplasm","Ovarian Carcinoma","Ovarian Carcinosarcoma","Stage III Cervical Cancer AJCC v8","Stage III Vaginal Cancer AJCC v8","Stage III Vulvar Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Vaginal Cancer AJCC v8","Stage IV Vulvar Cancer AJCC v8","Triple-Negative Breast Carcinoma","Uterine Corpus Carcinosarcoma","RECRUITING","2026-08-06",{"date":47,"type":48},"2026-08-10","ACTUAL",{"date":50,"type":20},"2027-02-22",{"date":52,"type":20},"2028-01-16",{"name":54,"class":55},"City of Hope Medical Center","OTHER",11,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":64,"minAge":17,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":21,"phases":67,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100375535","phase-1-nelfinavir-cisplatin-and-external-beam-radiation-therapy-for-the-treatment-of-locally-advanced-vulvar-cancer-that-cannot-be-removed-by-surgery-100375535","NCT04169763","Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery","A Phase I Study of Nelfinavir and Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Vulvar Cancer Not Amenable to Surgical Resection","Inclusion Criteria:\n\n* All patients with primary, previously untreated, histologically confirmed invasive carcinoma of the vulva (any cell type) not amenable to surgical excision. Clinical stages T2-T4, N0-3, M0. Hematoxylin \\& eosin (H \\& E) stained slide showing documentation of the primary invasive cancer is required. All specimens of primary tumor require documentation of type\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fmicroliter (performed within 28 days from signing consent form)\n* Platelet count \\>= 100,000\u002Fmicroliter (performed within 28 days from signing consent form)\n* Creatinine \\\u003C 2.0 mg\u002FdL (performed within 28 days from signing consent form)\n* Total bilirubin =\\\u003C 1.5 times normal (performed within 28 days from signing consent form)\n* Glutamic-oxaloacetic transaminase (SGOT) =\\\u003C 3 times normal (performed within 28 days from signing consent form)\n* Patients with an Eastern Cooperative Oncology Group\u002FGynecologic Oncology Group (ECOG\u002FGOG) performance status of 0, 1, or 2\n* Patients with ureteral obstruction must be treated with stent or nephrostomy tube\n* Patients must be consented within twelve (12) weeks of diagnosis or must be restaged\n* Patients of childbearing potential must use an effective form of birth control. \"Patients receiving oral contraceptives should be instructed that alternate or additional contraceptive measures should be used during therapy with VIRACEPT.\"\n* Confirmed seronegative HIV status within 3 months of signing consent\n* Patients must have signed an approved informed consent and authorization permitting release of personal health information\n\nExclusion Criteria:\n\n* Patients with stage T1N0 disease\n* Patients who have known metastases to other organs outside the radiation field at the time of the original clinical and surgical staging\n* Patients who have received previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of any kind for this malignancy\n* Patients with septicemia or severe infection\n* Patients who have circumstances that will not permit completion of this study or the required follow-up\n* Patients who are pregnant at the time of diagnosis and do not wish pregnancy termination prior to initiation of treatment\n* Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields\n* Patients with other concomitant malignancies (with the exception of non-melanoma skin cancer), who had (or have) any evidence of other cancer present within the last 5 years\n* Patients with gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)\n* Patients with poorly controlled diabetes mellitus despite medication\n* Patients taking anti-arrhythmic agents such as amiodarone, quinidine, rifampin, ergot derivatives such as ergotamine, St John's wort, human menopausal gonadotropin (HMG)-CoA reductase inhibitors such as lovastatin, neuroleptic such as pimozide, sedatives such as midazolam and triazolam among other CYP3A4 and CYP2C19 substrates\n* Patients with phenylketonuria\n* Patients with estimated glomerular filtration rate (eGFR) \\\u003C 30","ALL",{"count":66,"type":20},25,[68],"PHASE1","This phase I trial studies the side effects and best dose of nelfinavir when given together with cisplatin and external beam radiation therapy in treating patients with vulvar cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery. Nelfinavir is an antiviral drug normally used to treat human immunodeficiency virus (HIV). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving nelfinavir, cisplatin, and external beam radiation therapy may work better than giving only cisplatin and external beam radiation therapy in treating patients with vulvar cancer.",[71,38,72,73,74,75],"Stage II Vulvar Cancer AJCC v8","Stage IIIA Vulvar Cancer AJCC v8","Stage IIIB Vulvar Cancer AJCC v8","Stage IIIC Vulvar Cancer AJCC v8","Stage IVA Vulvar Cancer AJCC v8","2026-05-18",{"date":78,"type":48},"2026-05-20",{"date":80,"type":48},"2020-08-07",{"date":82,"type":20},"2026-12-31",{"name":84,"class":55},"M.D. Anderson Cancer Center",1]