Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-01-17 @ 1:28 AM
Study NCT ID:
NCT00963261
Status:
UNKNOWN
Last Update Posted:
2010-06-25
First Post:
2009-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life and Psychological Well-being in Patients With Malignant Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-24', 'studyFirstSubmitDate': '2009-08-20', 'studyFirstSubmitQcDate': '2009-08-20', 'lastUpdatePostDateStruct': {'date': '2010-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in quality of life', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Changes in fatigue', 'timeFrame': '1 year'}, {'measure': 'Changes in psychological distress', 'timeFrame': '1 year'}, {'measure': 'Changes in depressive syndrome', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['melanoma', 'interferon-a', 'quality of life', 'psychological distress', 'depressive symptoms', 'side effects'], 'conditions': ['Malignant Melanoma']}, 'referencesModule': {'references': [{'pmid': '25304729', 'type': 'DERIVED', 'citation': 'Reuter K, Albrecht K, Seelig H, Meiss F, Mauch C, Kreuzberg N, Nashan D. Health-related quality of life, fatigue, and depression under low-dose IFN-alpha therapy in melanoma patients. J Immunother. 2014 Nov-Dec;37(9):461-7. doi: 10.1097/CJI.0000000000000057.'}, {'pmid': '24136099', 'type': 'DERIVED', 'citation': 'Albrecht KJ, Nashan D, Meiss F, Bengel J, Reuter K. Shared decision making in dermato-oncology: preference for involvement of melanoma patients. Melanoma Res. 2014 Feb;24(1):68-74. doi: 10.1097/CMR.0000000000000030.'}, {'pmid': '23288588', 'type': 'DERIVED', 'citation': 'Albrecht K, Droll H, Giesler JM, Nashan D, Meiss F, Reuter K. Self-efficacy for coping with cancer in melanoma patients: its association with physical fatigue and depression. Psychooncology. 2013 Sep;22(9):1972-8. doi: 10.1002/pon.3238. Epub 2013 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyse the physical and psychological side-effects in the course of treatment with IFN-alpha. The effectiveness of a specific intervention for the management of these side-effects is evaluated.', 'detailedDescription': "Today, the consideration of the side effects of intensive treatment measures and their influence on quality of life are regarded as standard procedures in oncology. Quality of life measurements have found their way into clinical studies as patient-reported outcomes. In comparison to other tumor types, the field of dermato-oncology has had less research activity concerning quality of life. However, in recent years more attention has been paid to health related quality of life in malignant melanoma patients, especially under adjuvant treatment with interferon-alpha. Data about high dose IFN-α treatment, especially from the USA, show that there are significant physical and psychological side effects, such as fatigue and depression, which often lead to dosage reduction or termination of treatment. As yet, there are very few systematic studies about low dose IFN-α treatment, especially in regard to the side effects during the course of the disease.\n\nConcerning treatment side-effects it is known throughout various areas of oncology that specific psycho-oncological interventions assist in the patients' adaptation to the illness and handling of the side effects of therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented and proven stage Ib up to stage IIIc malignant melanoma\n* No clinical and radiological evidence or suspicion of persistent disease\n* Treatment with IFN-α within a study or analog treatment schedule with IFN-α\n* ECOG performance status \\< 2\n* Constant after care\n* Informed consent to participate in the study\n* melanoma diagnosis within the last 5 years or therapy, recurrence or progression within this period of time.\n\nExclusion Criteria:\n\n* Inoperable lymph nodes- or distant metastases\n* Tumors of other origins or localisations within the past 10 years\n* Severe and permanent infectious diseases, e. g. HIV or hepatitis\n* Participation in other treatment studies apart from IFN-α\n* Insufficient knowledge of German language'}, 'identificationModule': {'nctId': 'NCT00963261', 'briefTitle': 'Quality of Life and Psychological Well-being in Patients With Malignant Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'officialTitle': 'Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy -', 'orgStudyIdInfo': {'id': 'PO5098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'psycho-oncological intervention', 'description': 'stepped care psycho-oncological intervention', 'interventionNames': ['Behavioral: psycho-oncological intervention']}, {'type': 'NO_INTERVENTION', 'label': 'control group'}], 'interventions': [{'name': 'psycho-oncological intervention', 'type': 'BEHAVIORAL', 'description': 'stepped care treatment program with different elements (patient information, exercise, psychoeducation, individual and group therapy, psycho-pharmacology)', 'armGroupLabels': ['psycho-oncological intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Cornelia Mauch, MD', 'role': 'CONTACT'}], 'facility': 'University Medical Center Collogne, Department of Dermatology', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '79104', 'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dorothee Nashan, MD', 'role': 'CONTACT'}, {'name': 'Katrin Reuter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Center Freiburg, Department of Dermatology', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'centralContacts': [{'name': 'Katrin Reuter, PhD', 'role': 'CONTACT', 'email': 'katrin.reuter@uniklinik-freiburg.de', 'phone': '+497612706986'}, {'name': 'Karoline Albrecht, dipl. psych.', 'role': 'CONTACT', 'email': 'karoline.albrecht@uniklinik-freiburg.de', 'phone': '+497612706990'}], 'overallOfficials': [{'name': 'Katrin Reuter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy'}, {'name': 'Dorothee Nashan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center, Department of Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Essex Pharma GmbH', 'class': 'INDUSTRY'}, {'name': 'Universitätsklinikum Köln', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Katrin Reuter, PhD; Dorothee Nashan, MD', 'oldOrganization': 'University Medical Center Freiburg'}}}}