NCT04101123

Brief Summary

Aim of this study is to investigate the influence of social factors on participation and activity among children and adolescents aged 10-18 years with leukemia, brain tumors, and sarcomas. Furthermore personal and treatment-related factors and their impact on participation will be explored

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

3.5 years

First QC Date

September 23, 2019

Last Update Submit

June 26, 2024

Conditions

LeukemiaBrain TumorSarcomaChildhood CancerCancerAdolescent Cancer

Keywords

Social inequalitiesSocial dimensions of healthBrain tumorsLeukemiaSarcomasChildhood CancerChildren and adolescents with cancer

Outcome Measures

Primary Outcomes (2)

  • Social participation and activity

    The Child and Adolescent Scale of Participation, CASP

    Within the first month after diagnosis until half a year after intensive treatment

  • Level of quality of life

    Questionnaire to assess Health Related Quality of Life in chronically ill Children and Adolescents, KINDL Subscales: physical well-being, emotional well-being, self-esteem, family, friends, school, and a total score Values: range from 0 to 100 (higher values represent better quality of life)

    Within the first month after diagnosis until half a year after intensive treatment

Secondary Outcomes (12)

  • Evaluation of the treatment

    End of intensive treatment

  • Self-concept

    Within the first month after diagnosis until half a year after intensive treatment

  • Fatigue

    Within the first month after diagnosis until half a year after intensive treatment

  • Social support

    Within the first month after diagnosis until half a year after intensive treatment

  • Illness perception

    Within the first month after diagnosis until half a year after intensive treatment

  • +7 more secondary outcomes

Other Outcomes (10)

  • Parental coping with chronic childhood disease

    Within the first month after diagnosis until half a year after intensive treatment

  • Psychosocial needs

    Within the first month after diagnosis until the end of intensive treatment

  • Evaluation of the treatment

    End of intensive treatment

  • +7 more other outcomes

Study Arms (1)

Children and adolescents with cancer

Children and adolescents between 10-18 years with newly diagnosed leukemia, brain tumors, and sarcomas

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

Children and adolescents with cancer

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 leukemia, brain tumors, and sarcomas who are between 10 to 18 years old and their parents

You may qualify if:

  • newly diagnosed with confirmed leukemia, brain tumor or sarcoma
  • age 10-18 years
  • written informed consent of the patient and of one of the parents if they are under the age of 18

You may not qualify if:

  • having a relapse or secondary tumor
  • insufficient command of German
  • profound cognitive and physical impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Medical Sociology

Halle, Germany

Location

Related Publications (1)

  • Roick J, Berner R, Bernig T, Erdlenbruch B, Escherich G, Faber J, Klein C, Bochennek K, Kratz C, Kuhr J, Langler A, Lode HN, Metzler M, Muller H, Reinhardt D, Sauerbrey A, Schepper F, Scheurlen W, Schneider D, Schwabe GC, Richter M. Social inequalities in the participation and activity of children and adolescents with leukemia, brain tumors, and sarcomas (SUPATEEN): a protocol for a multicenter longitudinal prospective observational study. BMC Pediatr. 2020 Jan 31;20(1):48. doi: 10.1186/s12887-020-1943-3.

    PMID: 32005112DERIVED

MeSH Terms

Conditions

LeukemiaBrain NeoplasmsSarcomaNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, Connective and Soft Tissue

Study Officials

  • Matthias Richter, Prof. Dr.

    Martin-Luther-Universität Halle-Wittenberg

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 24, 2019

Study Start

January 1, 2020

Primary Completion

July 1, 2023

Study Completion

December 31, 2023

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)