Classical Hodgkin LymphomaNCT02808520
Social Inequalities in the Participation and Activity in Children and Adolescents With Hodgkin-lymphoma
An observational study of Classical Hodgkin Lymphoma, run by Martin-Luther-Universität Halle-Wittenberg.
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Classical Hodgkin Lymphoma
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents with hodgkin-lymphoma and their parents
Who may be able to join
- 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
Who cannot join
- other (simultaneous) malignancies
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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).
- Conditions
- Classical Hodgkin Lymphoma
- Keywords
- Social participation, Children and adolescents with cancer, Quality of life with hodgkin-lymphoma, Social inequalities and cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hodgkin-lymphoma | Children and adolescents aged 10-18 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social participation
The Child and Adolescent Scale of Participation, CASP
Measured: 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
Measured: one month after diagnosis until two years
Secondary outcomes (10)
Understanding of illness
Illness Perception Questionnaire, IPQ
Measured: one month after diagnosis until two years
Autonomy
Subscale Autonomy from the Health-Related Quality of Life Questionnaire for Children and Adolescents, Kidscreen
Measured: one month after diagnosis until two years
Self-efficacy
Self-Efficacy for Managing Chronic Disease 6-Item Scale, SES6
Measured: one month after diagnosis until two years
Optimism
Subscale from The Bern Subjective Well-Being Questionnaire for Adolescents, BFW
Measured: one month after diagnosis until two years
Coping
Coping Questionnaire for Children and Adolescents, CODI
Measured: one month after diagnosis until two years
Sense of coherence
Children Sense of Coherence Scale, C-SOC
Measured: one month after diagnosis until two years
Behavioural disorders and strengths
Strengths and Difficulties Questionnaire, SDQ
Measured: one month after diagnosis until two years
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
Measured: one month after diagnosis until two years
Satisfaction with treatment
Questionnaire to assess the Satisfaction with the Treatment, FBB
Measured: one month after diagnosis until two years
Social support
Social Support Scale, SSS
Measured: one month after diagnosis until two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Aid, University of Giessen
- Responsible party
- Principal investigator, Julia Roick, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Matthias Richter, Prof. PhD, Study chair, Institute of Medical Sociology, Martin Luther University Halle-WittenbergDieter Körholz, Prof. MD, Study chair, Center for Pediatrics and Adolescent Medicine, Justus-Liebig University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808520
- Sponsor's protocol ID
- 111412
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02808520
- Acronym / sponsor ID
- 111412
- Conditions
- Classical Hodgkin Lymphoma
- Keywords
- Social participation, Children and adolescents with cancer, Quality of life with hodgkin-lymphoma, Social inequalities and cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- German Cancer Aid, University of Giessen
- Study start
- Mar 2016
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hodgkin-lymphoma | – | –Children and adolescents aged 10-18 years |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents with hodgkin-lymphoma and their parents
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- other (simultaneous) malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Social participation
Time frame: one month after diagnosis until two years
The Child and Adolescent Scale of Participation, CASP
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
10 secondary outcomes
Understanding of illness
Time frame: one month after diagnosis until two years
Autonomy
Time frame: one month after diagnosis until two years
Self-efficacy
Time frame: one month after diagnosis until two years
Optimism
Time frame: one month after diagnosis until two years
Coping
Time frame: one month after diagnosis until two years
Sense of coherence
Time frame: one month after diagnosis until two years
Behavioural disorders and strengths
Time frame: one month after diagnosis until two years
Fatigue
Time frame: one month after diagnosis until two years
Satisfaction with treatment
Time frame: one month after diagnosis until two years
Social support
Time frame: one month after diagnosis until two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
Related trials for Classical Hodgkin Lymphoma
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A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
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Active, not recruitingPhase 2
Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)
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Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
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Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
Ann Arbor Stage IIB Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma
RecruitingPhase 1/2
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
Hodgkin Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Richter, Prof. PhD study chair
Institute of Medical Sociology, Martin Luther University Halle-Wittenberg
Dieter Körholz, Prof. MD study chair
Center for Pediatrics and Adolescent Medicine, Justus-Liebig University of Giessen
Questions about this trial
What is this clinical trial studying?
An observational study of Classical Hodgkin Lymphoma, run by Martin-Luther-Universität Halle-Wittenberg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Roick, MSc (+49 345 557 1136, julia.roick@medizin.uni-halle.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social participation (time frame: one month after diagnosis until two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.