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

Classical Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02808520
• Other study ID #: 111412
• Status: Not yet recruiting
• Phase: N/A
• First received: June 16, 2016
• Last updated: June 20, 2016
• Start date: March 2016
• Est. completion date: February 2020

Study information

• Verified date: June 2016
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: Julia Roick, MSc
• Phone: +49 345 557 1136
• Email: julia.roick[@]medizin.uni-halle.de
• Is FDA regulated: No
• Health authority: Germany: German Cancer Aid
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Classical Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	German Cancer Aid, University of Giessen

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental coping with chronic childhood disease	Coping Health Inventory for Parents, CHIP (parental questionnaire)	one month after diagnosis until two years	No
Other	Consequences of chronic conditions and disability in childhood and adolescence for the family	Impact on Family Scale in Families with Children with Disabilities, FaBel (parental questionnaire)	one month after diagnosis until two years	No
Other	Family atmosphere	Family Environment Scale, FES (parental questionnaire)	one month after diagnosis until two years	No
Other	Psychosocial needs	Short-Form Supportive Care Needs Survey Questionnaire, SCNS-SF34 (parental questionnaire)	one month after diagnosis until two years	No
Other	Use of psychosocial care services	(parental questionnaire)	one month after diagnosis until two years	No
Other	Satisfaction with treatment	Questionnaire to assess the Satisfaction with the Treatment, FBB (parental questionnaire)	one month after diagnosis until two years	No
Primary	Social participation	The Child and Adolescent Scale of Participation, CASP	one month after diagnosis until two years	No
Primary	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	No
Secondary	Understanding of illness	Illness Perception Questionnaire, IPQ	one month after diagnosis until two years	No
Secondary	Autonomy	Subscale Autonomy from the Health-Related Quality of Life Questionnaire for Children and Adolescents, Kidscreen	one month after diagnosis until two years	No
Secondary	Self-efficacy	Self-Efficacy for Managing Chronic Disease 6-Item Scale, SES6	one month after diagnosis until two years	No
Secondary	Optimism	Subscale from The Bern Subjective Well-Being Questionnaire for Adolescents, BFW	one month after diagnosis until two years	No
Secondary	Coping	Coping Questionnaire for Children and Adolescents, CODI	one month after diagnosis until two years	No
Secondary	Sense of coherence	Children Sense of Coherence Scale, C-SOC	one month after diagnosis until two years	No
Secondary	Behavioural disorders and strengths	Strengths and Difficulties Questionnaire, SDQ	one month after diagnosis until two years	No
Secondary	Fatigue	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	No
Secondary	Satisfaction with treatment	Questionnaire to assess the Satisfaction with the Treatment, FBB	one month after diagnosis until two years	No
Secondary	Social support	Social Support Scale, SSS	one month after diagnosis until two years	No