Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-12 @ 1:46 PM
Study NCT ID:
NCT02808520
Status:
UNKNOWN
Last Update Posted:
2016-06-21
First Post:
2016-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social Inequalities in the Participation and Activity in Children and Adolescents With Hodgkin-lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-20', 'studyFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2016-06-20', 'lastUpdatePostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Parental coping with chronic childhood disease', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Coping Health Inventory for Parents, CHIP (parental questionnaire)'}, {'measure': 'Consequences of chronic conditions and disability in childhood and adolescence for the family', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Impact on Family Scale in Families with Children with Disabilities, FaBel (parental questionnaire)'}, {'measure': 'Family atmosphere', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Family Environment Scale, FES (parental questionnaire)'}, {'measure': 'Psychosocial needs', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Short-Form Supportive Care Needs Survey Questionnaire, SCNS-SF34 (parental questionnaire)'}, {'measure': 'Use of psychosocial care services', 'timeFrame': 'one month after diagnosis until two years', 'description': '(parental questionnaire)'}, {'measure': 'Satisfaction with treatment', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Questionnaire to assess the Satisfaction with the Treatment, FBB (parental questionnaire)'}], 'primaryOutcomes': [{'measure': 'Social participation', 'timeFrame': 'one month after diagnosis until two years', 'description': 'The Child and Adolescent Scale of Participation, CASP'}, {'measure': 'Quality of life', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Questionnaire to assess Health Related Quality of Life in chronically ill Children and Adolescents, KINDL'}], 'secondaryOutcomes': [{'measure': 'Understanding of illness', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Illness Perception Questionnaire, IPQ'}, {'measure': 'Autonomy', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Subscale Autonomy from the Health-Related Quality of Life Questionnaire for Children and Adolescents, Kidscreen'}, {'measure': 'Self-efficacy', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Self-Efficacy for Managing Chronic Disease 6-Item Scale, SES6'}, {'measure': 'Optimism', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Subscale from The Bern Subjective Well-Being Questionnaire for Adolescents, BFW'}, {'measure': 'Coping', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Coping Questionnaire for Children and Adolescents, CODI'}, {'measure': 'Sense of coherence', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Children Sense of Coherence Scale, C-SOC'}, {'measure': 'Behavioural disorders and strengths', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Strengths and Difficulties Questionnaire, SDQ'}, {'measure': 'Fatigue', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Subscale Fatigue from the Questionnaire to assess Quality of Life of Cancer Patients developed by the European Organisation for Research and Treatment of Cancer, EORTC QLQ-C30'}, {'measure': 'Satisfaction with treatment', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Questionnaire to assess the Satisfaction with the Treatment, FBB'}, {'measure': 'Social support', 'timeFrame': 'one month after diagnosis until two years', 'description': 'Social Support Scale, SSS'}]}, 'conditionsModule': {'keywords': ['Social participation', 'Children and adolescents with cancer', 'Quality of life with hodgkin-lymphoma', 'Social inequalities and cancer'], 'conditions': ['Classical Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'Purpose of this study is to determine the influence of social factors on participation and activity among children and adolescents aged 10-18 years with hodgkin-lymphoma. Furthermore personal and treatment-related factors and their impact on participation will be explored.', 'detailedDescription': 'Hodgkin-lymphoma is a rare malignancy among children and adolescents (about 140 each year in Germany) which is highly curable. Beside this therapeutic success, a lot of therapy-related long-term problems arise (e.g. fertility disorders, thyroid diseases, secondary malignancies). While most of the studies focused on mental and physical impairments, little attention has been drawn to social dimensions of health. Due to the disease and the requirements of the therapy, participation of children with hodgkin-lymphoma can be impaired acutely or chronically. This can be of serious consequences, because participation in daily life is an important component of the development of children and adolescents. To determine the influence of social, personal and treatment-related factors on participation, all patients who were actual treated in the international therapy study EuroNet-PHL-C2 in all of Germany (N ≈ 700) and their parents will be interviewed. Statistical analyses will be done using descriptive and multivariate methods taking account of treatment-related issues (e.g. stage of disease, chemotherapy, radiotherapy, progression/relapse).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolescents with hodgkin-lymphoma and their parents', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* histologically confirmed primary diagnosis of classical Hodgkin's Lymphoma\n* 10-18 years\n* written informed consent of the patient and/or the patient's parents or guardian according to national laws\n\nExclusion Criteria:\n\n* other (simultaneous) malignancies"}, 'identificationModule': {'nctId': 'NCT02808520', 'briefTitle': 'Social Inequalities in the Participation and Activity in Children and Adolescents With Hodgkin-lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Martin-Luther-Universität Halle-Wittenberg'}, 'officialTitle': 'Social Inequalities in the Participation and Activity in Children and Adolescents With Hodgkin-lymphoma. A Prospective Multicenter Cohort Study of Social and Personal Influencing Factors', 'orgStudyIdInfo': {'id': '111412'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hodgkin-lymphoma', 'description': 'Children and adolescents aged 10-18 years'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Julia Roick, MSc', 'role': 'CONTACT', 'email': 'julia.roick@medizin.uni-halle.de', 'phone': '+49 345 557 1136'}], 'overallOfficials': [{'name': 'Matthias Richter, Prof. PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Medical Sociology, Martin Luther University Halle-Wittenberg'}, {'name': 'Dieter Körholz, Prof. MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Center for Pediatrics and Adolescent Medicine, Justus-Liebig University of Giessen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martin-Luther-Universität Halle-Wittenberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Cancer Aid', 'class': 'OTHER'}, {'name': 'University of Giessen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Julia Roick', 'investigatorAffiliation': 'Martin-Luther-Universität Halle-Wittenberg'}}}}