Condition category
Mental and Behavioural Disorders
Date applied
18/07/2011
Date assigned
13/10/2011
Last edited
04/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Children of cancer patients are of increased risk developing psychosocial problems. Psychosocial problems can be problems with behaviours and emotions. It is important that help be provided for families in this situation. A preventive counseling programme for these children could be helpful in improving their quality of life and improve their behavior. The aim of this study is to evaluate our intervention in a controlled trail in Hamburg, Berlin and Leipzig (Germany) to see if it can improve the children's quality of life and psychosocial problems.

Who can participate?
Families who have a parent with cancer and at least one child between 0-21 years old who are seeking support.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive child-focused preventive counseling programme. This consists of an evaluation of the parents, the child (or children) and a maximum of six individually customised sessions. Further single sessions with one or each child or parents alone or with family, parents and siblings are available. Participants in the second group do not receive the programme. Participants are assessed before and after treatment and are followed up six months after the programme to address their health related quality of life and their behavioural and emotional problems.

What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.

Where is the study run from?
University Medical Centre Hamburg-Eppendorf (Germany)

When is the study starting and how long is it expected to run for?
December 2009 to March 2012.

Who is funding the study?
German Cancer Aid (Germany)

Who is the main contact?
Thomas Krattenmacher
(t.krattenmacher@uke.de)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Birgit Möller

ORCID ID

Contact details

University Medical Centre Hamburg-Eppendorf
Centre of Psychosocial Medicine
Department of Child and Adolescent Psychiatry and Psychotherapy
Martinistrasse 52
Hamburg
20246
Germany
-
b.moeller@uke.uni-hamburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A naturalistic semi-controlled trial of a manualised preventive counselling program for children of parents with cancer

Acronym

COSIP

Study hypothesis

Evaluation of interventions’ effectiveness of a manualized child-focused preventive counselling program for children of parents with cancer compared to a naturalistic course of a cohort elsewhere without specific intervention

Ethics approval

Ethics Committee of the Medical Association of Hamburg, 15 October 2009, ref: PV3322

Study design

Multi-centre naturalistic controlled trial. One group receives intervention, the other not. Randomization of a previous RCT (ISRCTN34770541) had to be stopped.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Child and adolescent psychotherapy and psychiatry, psycho-oncology

Intervention

A manualised child-focused preventive counselling program consisting of
1. Evaluation of parent(s)
2. Evaluation of child or children
3. A maximum of six individually customised and focused sessions (e.g. further single sessions with one or each child or a parent alone, sessions with family, parents or siblings)
4. All outcomes will be measured before and after treatment, and at 6 month follow up

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Children’s health-related quality of life with Kid-Screen (8-18 years) rated from children’s and parents’ view
2. Children’s behavioural and emotional problems measured with Strengths and Difficulties Questionnaire (11-18 years) rated from children’s and parents’ view

Secondary outcome measures

1. Parents’ self-rated anxiety and depression measured with Hospital Anxiety and Depression Scale (HADS)
2. Family Assessment Device (FAD) to measure familial functioning from parents’ perspective
3. Family Crisis-Oriented Personal Evaluation Scales (F-COPES) to measure familial coping behaviour in crisis situations
4. Freiburg Questionnaire of Coping with Illness (FKV) to measure parental coping with illness
5. Health Survey (SF-8) to measure parental quality of life
6. Connor-Davidson Resilience Scale (CD-Risc) to measure six different resilience factors
7. Kid-Cope (13-18 years) to measure children’s and adolescent’s cognitive and behavioural coping with parents’ cancer disease
8. Ad hoc developed intervention program rating scales to evaluate specific intervention contents and satisfaction with intervention; ratings from parents’, children’s (over 11 years) and counsellors’ viewpoint

Overall trial start date

07/12/2009

Overall trial end date

30/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Wishing/seeking support
2. At least one parent has cancer
3. At least one child between 0-21 years

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100 families

Participant exclusion criteria

1. Neither parent has cancer (e.g. other chronic diseases)
2. No informed consent for study participation (the program is provided without study participation)
3. At least one parent has psychotic symptoms or a psychotic mental disorder (ICD-10 or DSM-IV)
4. Acute endangerment of child to self or others
5. Insufficient German language abilities
6. Insufficient mobility of ill parent (the program is then offered to other family members)

Recruitment start date

07/12/2009

Recruitment end date

30/03/2012

Locations

Countries of recruitment

Germany

Trial participating centre

University Medical Centre Hamburg-Eppendorf
Hamburg
20246
Germany

Sponsor information

Organisation

German Cancer Aid [Deutsche Krebshilfe] (Germany)

Sponsor details

Buschstr. 32
Bonn
53113
Germany
+49 (0)228 729900
deutsche@krebshilfe.de

Sponsor type

Charity

Website

http://www.krebshilfe.de

Funders

Funder type

Charity

Funder name

German Cancer Aid [Deutsche Krebshilfe] (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/05/2017: Plain English summary added.