Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-10 @ 12:22 AM
Study NCT ID:
NCT04152512
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-01
First Post:
2019-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014846', 'term': 'Vulvar Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014845', 'term': 'Vulvar 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'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2019-10-27', 'studyFirstSubmitQcDate': '2019-11-01', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global quality of life', 'timeFrame': '1 year after end of treatment', 'description': 'Measured by the European Organisation of Research and Treatment of Cancer (EORTC)-QLQ-C30-questionnaire.\n\nMeasurement on a scale between 0-and 100. Higher values represent better quality of life. A change of at least 5-8 points is regarded as clinically significant.'}, {'measure': 'Vulvar-cancer-specific quality of life', 'timeFrame': '1 year after end of treatment', 'description': 'Measured by the EORTC-QLQ-VU34-questionnaire. Higher values represent higher quality of life.'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with Care', 'timeFrame': '3--4 months after end of treatment', 'description': 'Measured by EORTC-PATSAT-questionnaire. Higher score represent higher satisfaction with care.'}, {'measure': 'Depression and anxiety', 'timeFrame': '1 year after end of treatment.', 'description': 'Measured by the Hospital Anxiety and Depression Index (HADS)-questionnaire. Higher scores represent more depression and anxiety'}, {'measure': 'Unmet needs', 'timeFrame': '3-4 months after end of treatment.', 'description': 'Measured by the Supportive Care Needs Survey-Short Form (SCNS-SF)-34-questionnaire. Higher scores represent higher needs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Questionnaire', 'EORTC QLQ C30 + VU34', 'Hospital Depression and Anxiety Scale', 'EORTC-PATSAT', 'Supportive Care Needs Survey Short Form'], 'conditions': ['Vulvar Cancer', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '40490985', 'type': 'DERIVED', 'citation': 'Zach D, Jensen PT, Falconer H, Kolkova Z, Bohlin KS, Kjolhede P, Raices Cruz I, Avall-Lundqvist E, Floter Radestad A. The impact of local symptoms on health-related quality of life in vulvar cancer survivors-A nationwide prospective study. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1517-1529. doi: 10.1111/aogs.15164. Epub 2025 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective, longitudinal Swedish multi-center study is to assess the quality of life, treatment-related morbidity, unmet needs and satisfaction with care after treatment for vulvar cancer, evaluated by a validated questionnaire.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nInformation about:\n\n* General and vulvar-cancer-specific quality of life before and after any treatment for newly diagnosed vulvar cancer\n* Treatment-related morbidity after any treatment for newly diagnosed vulvar cancer\n* Unmet needs of patients with newly diagnosed vulvar cancer\n* Satisfaction with care after any treatment for newly diagnosed vulvar cancer in Sweden.\n\nOUTLINE:\n\nThe study is planned as a prospective, longitudinal multi-centre study in Sweden. Since 2017, the treatment of vulvar cancer patients has been accredited to four tertiary referral university hospitals in Sweden; the Sahlgrenska University hospital in Gothenburg, the Linköping University hospital, the Skåne University hospital in Lund and the Karolinska University hospital in Stockholm.\n\n150 patients are estimated for inclusion during a time frame of about 18 months.\n\nEligible patients will be asked to complete a validated questionnaire at different points of time (before and after treatment). Calculating a response rate of about 50% - 60%, this will result in at least 80 completed questionnaires.\n\nThe questionnaires consist of the following parts:\n\n* European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30\n* European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-VU-34 (Vulva-specific module)\n* Hospital Depression and Anxiety Scale (HADS)\n* Supportive Care Needs Survey Short Form, excerpt (SCNS-SF34)\n* European Organisation for Research and Treatment of Cancer (EORTC)-PATSAT (Patient Satisfaction), excerpt\n* Demographic data\n* 25 self-constructed (and validated) questions\n\nRESULTS:\n\nResults are expected to be available in 2021.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with newly diagnosed invasive vulvar cancer in Sweden during the study time frame.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of vulvar cancer, all stages, all planned treatments\n* Informed consent\n\nExclusion Criteria:\n\n* Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia'}, 'identificationModule': {'nctId': 'NCT04152512', 'acronym': 'PROVE', 'briefTitle': 'Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Quality of Life, Specific Needs and Satisfaction With Care After Treatment for Vulvar Cancer - a Prospective, Longitudinal Swedish Nationwide Study', 'orgStudyIdInfo': {'id': '2018/1402-31/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Whole Cohort', 'description': 'Whole cohort administration of questionnaire at 7 times', 'interventionNames': ['Behavioral: Questionnaire administration']}], 'interventions': [{'name': 'Questionnaire administration', 'type': 'BEHAVIORAL', 'description': 'Questionnaire administration (4 different forms: pre-treatment, 3-4 months after treatment, 1 year after treatment, 2-5 years (yearly) after treatment', 'armGroupLabels': ['Whole Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17776', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linkopings University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Skanes University Hospital Lund', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Diana Zach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, {'name': 'Skane University Hospital', 'class': 'OTHER'}, {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, senior consultant', 'investigatorFullName': 'Diana Zach', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}