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

June 20, 2016 updated by: Julia Roick, Martin-Luther-Universität Halle-Wittenberg

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

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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).

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and adolescents with hodgkin-lymphoma and their parents

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Hodgkin-lymphoma
Children and adolescents aged 10-18 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social participation
Time Frame: one month after diagnosis until two years
The Child and Adolescent Scale of Participation, CASP
one month after diagnosis until two years
Quality of life
Time Frame: one month after diagnosis until two years
Questionnaire to assess Health Related Quality of Life in chronically ill Children and Adolescents, KINDL
one month after diagnosis until two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understanding of illness
Time Frame: one month after diagnosis until two years
Illness Perception Questionnaire, IPQ
one month after diagnosis until two years
Autonomy
Time Frame: one month after diagnosis until two years
Subscale Autonomy from the Health-Related Quality of Life Questionnaire for Children and Adolescents, Kidscreen
one month after diagnosis until two years
Self-efficacy
Time Frame: one month after diagnosis until two years
Self-Efficacy for Managing Chronic Disease 6-Item Scale, SES6
one month after diagnosis until two years
Optimism
Time Frame: one month after diagnosis until two years
Subscale from The Bern Subjective Well-Being Questionnaire for Adolescents, BFW
one month after diagnosis until two years
Coping
Time Frame: one month after diagnosis until two years
Coping Questionnaire for Children and Adolescents, CODI
one month after diagnosis until two years
Sense of coherence
Time Frame: one month after diagnosis until two years
Children Sense of Coherence Scale, C-SOC
one month after diagnosis until two years
Behavioural disorders and strengths
Time Frame: one month after diagnosis until two years
Strengths and Difficulties Questionnaire, SDQ
one month after diagnosis until two years
Fatigue
Time Frame: one month after diagnosis until two years
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
one month after diagnosis until two years
Satisfaction with treatment
Time Frame: one month after diagnosis until two years
Questionnaire to assess the Satisfaction with the Treatment, FBB
one month after diagnosis until two years
Social support
Time Frame: one month after diagnosis until two years
Social Support Scale, SSS
one month after diagnosis until two years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental coping with chronic childhood disease
Time Frame: one month after diagnosis until two years
Coping Health Inventory for Parents, CHIP (parental questionnaire)
one month after diagnosis until two years
Consequences of chronic conditions and disability in childhood and adolescence for the family
Time Frame: one month after diagnosis until two years
Impact on Family Scale in Families with Children with Disabilities, FaBel (parental questionnaire)
one month after diagnosis until two years
Family atmosphere
Time Frame: one month after diagnosis until two years
Family Environment Scale, FES (parental questionnaire)
one month after diagnosis until two years
Psychosocial needs
Time Frame: one month after diagnosis until two years
Short-Form Supportive Care Needs Survey Questionnaire, SCNS-SF34 (parental questionnaire)
one month after diagnosis until two years
Use of psychosocial care services
Time Frame: one month after diagnosis until two years
(parental questionnaire)
one month after diagnosis until two years
Satisfaction with treatment
Time Frame: one month after diagnosis until two years
Questionnaire to assess the Satisfaction with the Treatment, FBB (parental questionnaire)
one month after diagnosis until two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Collaborators

University of Giessen
German Cancer Aid

Investigators

  • Study Chair: Matthias Richter, Prof. PhD, Institute of Medical Sociology, Martin Luther University Halle-Wittenberg
  • Study Chair: Dieter Körholz, Prof. MD, Center for Pediatrics and Adolescent Medicine, Justus-Liebig University of Giessen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111412

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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