Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT07156903
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Needs of Patients and Care-givers During and After Radiotherapy of Patients With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative Evaluation of Interviews', 'timeFrame': 'interviews will take place once either during radiotherapy or during follow up (planned 30 participants each); Each interview is expected to last 60 minutes.', 'description': 'This is an exploratory, qualitative study. The data will be coded or analyzed thematically.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Qualitative Research', 'Prehabilitation'], 'conditions': ['Prostate Cancer Patients']}, 'descriptionModule': {'briefSummary': 'Exploratory qualitative survey to assess the needs of patients and their relatives during and after radiotherapy for prostate cancer and their attitudes and wishes regarding prehabilitation measures', 'detailedDescription': 'Across Germany, more than 500,000 people are newly diagnosed with cancer each year (Center for Cancer Registry Data, RKI, 2020). Prostate cancer, the most common cancer in men, affects more than 65,000 patients annually (https://www.krebsinformationsdienst.de/prostatakrebs). The gold standard for the treatment of advanced prostate cancer is radiotherapy combined with anti-hormonal therapy. If the cancer is detected earlier, surgery can be performed. Both procedures are then considered to be oncologically equivalent. Despite the most modern treatment methods and techniques, severe acute and long-term side effects still occur, which patients can experience as extremely limiting. These include, among other things, loss of libido and erectile function, the development of bladder weakness and even incontinence, and changes in bowel function (e.g., diarrhea).\n\nCurrently, patients often only begin treatments designed to mitigate these side effects during their rehabilitation, at least 4-6 weeks after therapy. However, the investigators believe that greater effects can be achieved and even the occurrence of serious side effects can be potentially prevented if treatment is initiated before or during therapy. This concept is called prehabilitation.\n\nIn order to develop a suitable prehabilitation program for prostate cancer patients undergoing curative radiation therapy (either definitive or postoperative), the investigators will conduct interviews with patients and, if possible, their immediate family members (e.g., partners) to learn more about their experiences before, during, and after the treatment. The investigators would also like to learn more about their attitudes and wishes regarding prehabilitation measures.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed Prostate Cancer with curativ intended Radiotherapy\n* min. 18 years\n* sufficient knowledge of German language for participation in interviews\n* Capacity to consent\n\nExclusion Criteria:\n\n* age \\<18 years'}, 'identificationModule': {'nctId': 'NCT07156903', 'acronym': 'PrähabPro', 'briefTitle': 'Evaluation of Needs of Patients and Care-givers During and After Radiotherapy of Patients With Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Qualitative Erhebung Zur Erfassung Der Bedürfnisse Von Patienten Und Deren Angehörigen während Und Nach Einer Strahlentherapie Bei Prostatakarzinomerkrankung Und Deren Einstellung Und Wünsche bezüglich Einer Prähabilitationsmaßnahme', 'orgStudyIdInfo': {'id': 'EA4/121/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'interviews', 'description': 'Patients will be asked to participate in interviews', 'interventionNames': ['Other: Interview']}], 'interventions': [{'name': 'Interview', 'type': 'OTHER', 'description': 'Patients and their care-givers will be asked to participate in interviews', 'armGroupLabels': ['interviews']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Franziska Hausmann, MD', 'role': 'CONTACT', 'email': 'franziska.hausmann@charite.de', 'phone': '+4930 450 557000'}], 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Franziska Hausmann, MD', 'role': 'CONTACT', 'email': 'franziska.hausmann@charite.de', 'phone': '+4930 450 557000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Prof. Dr. Franziska Hausmann', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}