Social Inequalities in the Participation and Activity in Children and Adolescents With Hodgkin-lymphoma

NCT ID: NCT02808520

Last Updated: 2016-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-02-29

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Classical Hodgkin Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hodgkin-lymphoma

Children and adolescents aged 10-18 years

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* histologically confirmed primary diagnosis of classical Hodgkin's Lymphoma
* 10-18 years
* written informed consent of the patient and/or the patient's parents or guardian according to national laws

Exclusion Criteria

* other (simultaneous) malignancies
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Cancer Aid

OTHER

Sponsor Role collaborator

University of Giessen

OTHER

Sponsor Role collaborator

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role lead

Responsible Party

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Julia Roick

MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Richter, Prof. PhD

Role: STUDY_CHAIR

Institute of Medical Sociology, Martin Luther University Halle-Wittenberg

Dieter Körholz, Prof. MD

Role: STUDY_CHAIR

Center for Pediatrics and Adolescent Medicine, Justus-Liebig University of Giessen

Central Contacts

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Julia Roick, MSc

Role: CONTACT

+49 345 557 1136

Other Identifiers

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111412

Identifier Type: -

Identifier Source: org_study_id

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