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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02808520
Recruitment Status : Unknown
Verified June 2016 by Julia Roick, Martin-Luther-Universität Halle-Wittenberg.
Recruitment status was:  Not yet recruiting
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Collaborators:
German Cancer Aid
University of Giessen
Information provided by (Responsible Party):
Julia Roick, Martin-Luther-Universität Halle-Wittenberg

Study Description
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Brief Summary:
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.

Condition or disease
Classical Hodgkin Lymphoma

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 Design
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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : March 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Social participation [ Time Frame: one month after diagnosis until two years ]
    The Child and Adolescent Scale of Participation, CASP

  2. 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


Secondary Outcome Measures :
  1. Understanding of illness [ Time Frame: one month after diagnosis until two years ]
    Illness Perception Questionnaire, IPQ

  2. 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

  3. Self-efficacy [ Time Frame: one month after diagnosis until two years ]
    Self-Efficacy for Managing Chronic Disease 6-Item Scale, SES6

  4. Optimism [ Time Frame: one month after diagnosis until two years ]
    Subscale from The Bern Subjective Well-Being Questionnaire for Adolescents, BFW

  5. Coping [ Time Frame: one month after diagnosis until two years ]
    Coping Questionnaire for Children and Adolescents, CODI

  6. Sense of coherence [ Time Frame: one month after diagnosis until two years ]
    Children Sense of Coherence Scale, C-SOC

  7. Behavioural disorders and strengths [ Time Frame: one month after diagnosis until two years ]
    Strengths and Difficulties Questionnaire, SDQ

  8. 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

  9. Satisfaction with treatment [ Time Frame: one month after diagnosis until two years ]
    Questionnaire to assess the Satisfaction with the Treatment, FBB

  10. Social support [ Time Frame: one month after diagnosis until two years ]
    Social Support Scale, SSS


Other Outcome Measures:
  1. Parental coping with chronic childhood disease [ Time Frame: one month after diagnosis until two years ]
    Coping Health Inventory for Parents, CHIP (parental questionnaire)

  2. 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)

  3. Family atmosphere [ Time Frame: one month after diagnosis until two years ]
    Family Environment Scale, FES (parental questionnaire)

  4. Psychosocial needs [ Time Frame: one month after diagnosis until two years ]
    Short-Form Supportive Care Needs Survey Questionnaire, SCNS-SF34 (parental questionnaire)

  5. Use of psychosocial care services [ Time Frame: one month after diagnosis until two years ]
    (parental questionnaire)

  6. Satisfaction with treatment [ Time Frame: one month after diagnosis until two years ]
    Questionnaire to assess the Satisfaction with the Treatment, FBB (parental questionnaire)


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents with hodgkin-lymphoma and their parents
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808520


Contacts
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Contact: Julia Roick, MSc +49 345 557 1136 julia.roick@medizin.uni-halle.de

Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
German Cancer Aid
University of Giessen
Investigators
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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
More Information
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Responsible Party: Julia Roick, MSc, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT02808520    
Other Study ID Numbers: 111412
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Keywords provided by Julia Roick, Martin-Luther-Universität Halle-Wittenberg:
Social participation
Children and adolescents with cancer
Quality of life with hodgkin-lymphoma
Social inequalities and cancer
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases