Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT03876366
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2019-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fertility Preservation in Men Affected by Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2019-02-26', 'studyFirstSubmitQcDate': '2019-03-12', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'male cancer patients level of information with regard to FP', 'timeFrame': 'Phase 1 online survey at baseline', 'description': 'Phase 1: exploratory online survey inquiring male cancer patients level of information with regard to FP'}, {'measure': 'male cancer patients level of information with regard to FP', 'timeFrame': 'Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)', 'description': 'Phase 2: interview (strictly exploratory) in focus groups collecting data on male cancer patients level of information with regard to FP'}], 'secondaryOutcomes': [{'measure': 'male cancer patients needs regarding decision-making about FP', 'timeFrame': 'Phase 1 online survey at baseline', 'description': 'exploratory online survey inquiring which kind of support regarding decision-making about FP do male cancer patients consider helpful'}, {'measure': 'male cancer patients expectation with regard to an online DA tool about FP', 'timeFrame': 'Phase 1 online survey at baseline', 'description': 'exploratory online survey inquiring how an online Decision Aid (DA) tool about FP has to be designed in order to be helpful for male cancer patients'}, {'measure': 'male cancer patients needs regarding decision-making about FP', 'timeFrame': 'Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)', 'description': 'Phase 2: interview (strictly exploratory) in focus groups evaluating which kind of support regarding decision-making about FP male cancer patients consider helpful'}, {'measure': 'male cancer patients expectation with regard to an online DA tool about FP', 'timeFrame': 'Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)', 'description': 'Phase 2: interview (strictly exploratory) in focus groups evaluating how an online DA tool about FP has to be designed in order to be helpful for male cancer patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer patients', 'male cancer patients', 'Decision Aid (DA)', 'online Decision Aid tool'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': "This is a single center cross-sectional retrospective study with a quantitative and qualitative approach (phase 1 and 2). In phase 1 an online survey will be realized and targets male cancer survivors. Phase 2 will take a qualitative approach, in which information about patient's experiences, needs and helpful support will be collected by establishing focus groups of cancer patients who had been diagnosed during the reproductive age.\n\nIn the end, the results of this study will be integrated into the development of an online support tool concerning Fertility Preservation (FP)."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients who are/were possible candidates for FP (patients with fertility compromising cancer treatment) will be invited to participate. Eligible patients will be approached by their former or current treating oncologist, urologist or specialist in reproductive medicine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* German speaking\n* Cancer diagnosis within the last 10 years (minimum age at diagnosis 13 years)\n* Cancer therapy that was expected to impair fertility\n\nExclusion Criteria:\n\n* Prepubertal at diagnosis'}, 'identificationModule': {'nctId': 'NCT03876366', 'briefTitle': 'Fertility Preservation in Men Affected by Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': "Fertility Preservation in Men Affected by Cancer: Assessment of Patients' Needs and Development of an Online Decision-aid", 'orgStudyIdInfo': {'id': '2017-02069; sp19Tschudin'}}, 'armsInterventionsModule': {'interventions': [{'name': 'online survey', 'type': 'OTHER', 'description': 'Part 1: online survey (quantitative) with questions on basic socio-demographic data, medical data and family characteristics (e.g. age, ethnicity, education) and information about FP.'}, {'name': 'focus group meeting', 'type': 'OTHER', 'description': 'Part 2: At the end of the online survey, participants are invited to attend one of the consecutively performed focus groups conducted according to standardized focus group methodology and moderated by a clinical psychologist and a specialist in reproductive medicine.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Frauenklinik University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Sibil Tschudin, PD Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Frauenklinik Universitätsspital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Krebsforschung Schweiz, Bern, Switzerland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}