NCT02808520

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

3.9 years

First QC Date

June 16, 2016

Last Update Submit

June 20, 2016

Conditions

Classical Hodgkin Lymphoma

Keywords

Social participationChildren and adolescents with cancerQuality of life with hodgkin-lymphomaSocial inequalities and cancer

Outcome Measures

Primary Outcomes (2)

  • Social participation

    The Child and Adolescent Scale of Participation, CASP

    one month after diagnosis until two years

  • Quality of life

    Questionnaire to assess Health Related Quality of Life in chronically ill Children and Adolescents, KINDL

    one month after diagnosis until two years

Secondary Outcomes (10)

  • Understanding of illness

    one month after diagnosis until two years

  • Autonomy

    one month after diagnosis until two years

  • Self-efficacy

    one month after diagnosis until two years

  • Optimism

    one month after diagnosis until two years

  • Coping

    one month after diagnosis until two years

  • +5 more secondary outcomes

Other Outcomes (6)

  • Parental coping with chronic childhood disease

    one month after diagnosis until two years

  • Consequences of chronic conditions and disability in childhood and adolescence for the family

    one month after diagnosis until two years

  • Family atmosphere

    one month after diagnosis until two years

  • +3 more other outcomes

Study Arms (1)

Hodgkin-lymphoma

Children and adolescents aged 10-18 years

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents with hodgkin-lymphoma and their parents

You may qualify if:

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

You may not qualify if:

  • other (simultaneous) malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Officials

  • 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 CHAIR

Central Study Contacts

Julia Roick, MSc

CONTACT

+49 345 557 1136julia.roick@medizin.uni-halle.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 21, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

June 21, 2016

Record last verified: 2016-06