CancerNCT00296907
Psychological Interventions in Siblings of Children With Cancer
A study testing Brief psychological intervention in people with Cancer, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
The purpose of the study is to evaluate the effectiveness of a two-session brief psychological intervention in siblings of pediatric cancer patients with regard to behavior problems and depression. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Cancer
- What is being tested?
- Brief psychological intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2006to Dec 2010
- Phase
- Interventional
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- brother or sister with newly diagnosed cancer treated at the University Children's Hospital command of the German language normal developmental level
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Zurich, Psychosomatic and Psychiatry
Zurich, CH-8032
About this study
Official title: Psychological Interventions in Siblings of Children With Cancer: a Randomized Controlled Study
The purpose of the study is to evaluate the effectiveness of a two-session brief psychological intervention in siblings of pediatric cancer patients with regard to behavior problems and depression.
Read the detailed description
Within a randomized controlled design the effects of a brief two-session psychological intervention (child, parents) shall be studied in 30 siblings of newly diagnosed pediatric cancer patients. After a baseline assessment 3-4 weeks after diagnosis participants are randomly assigned to an intervention or waiting list group. Both are re-assessed at 3 and 6 months by means of standardized questionnaires assessing psychological adaptation and behavior. The intervention is provided to the waiting list group after the 6-month assessment.
- Conditions
- Cancer
- Being tested
- Brief psychological intervention
- Keywords
- cancer, siblings, behavior, psychological adaptation, intervention
- Medical subject headings
- Neoplasms, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief psychological interventionBehavioural
Psychoeducation, provision of medical knowledge, coping skills training
| Study group | Role | What they receive |
|---|---|---|
| Psychological Intervention | Experimental | 2-session psychological intervention Receives: Behavioral: Brief psychological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
KIDSCREEN: health-related quality of life
Measured: baseline, 3 and 6 months post intervention
UCLA Child PTSD Reaction Index
Measured: baseline, 3 and 6 months post intervention
DIKJ (Depression-Inventory for Children and Adolescents)
Measured: baseline, 3 and 6 months post intervention
Child Behavior Checklist
Measured: Baseline, 3 and 6 months post intervention
Spence Children's Anxiety Scale
Measured: baseline, 3 and 6 months post intervention
Secondary outcomes (2)
Posttraumatic Distress Scale
Measured: baseline, 3 and 6 months post intervention
Symptom Checklist 27
Measured: baseline, 3 and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startApr 2006
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus A Landolt, PhD, Principal investigator, University Children's Hospital Zurich, Psychosomatic and Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296907
- Sponsor's protocol ID
- PIGO-1
- Status last verified
- Jul 2012
- First submitted
- 24 Feb 2006
- Last updated
- 30 Jul 2012
- Results posted
- No
Publications
Prchal A, Graf A, Bergstraesser E, Landolt MA. A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial. Child Adolesc Psychiatry Ment Health. 2012 Jan 11;6(1):3. doi: 10.1186/1753-2000-6-3.
PubMed 22236392
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Interventions in Siblings of Children With Cancer: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00296907
- Acronym / sponsor ID
- PIGO-1
- Conditions
- Cancer
- Keywords
- cancer, siblings, behavior, psychological adaptation, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Feb 2006 (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.
The purpose of the study is to evaluate the effectiveness of a two-session brief psychological intervention in siblings of pediatric cancer patients with regard to behavior problems and depression.
Detailed description
Within a randomized controlled design the effects of a brief two-session psychological intervention (child, parents) shall be studied in 30 siblings of newly diagnosed pediatric cancer patients. After a baseline assessment 3-4 weeks after diagnosis participants are randomly assigned to an intervention or waiting list group. Both are re-assessed at 3 and 6 months by means of standardized questionnaires assessing psychological adaptation and behavior. The intervention is provided to the waiting list group after the 6-month assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychological Intervention | Experimental | Behavioral: Brief psychological intervention2-session psychological intervention |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- brother or sister with newly diagnosed cancer treated at the University Children's Hospital command of the German language normal developmental level
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief psychological interventionPsychoeducation, provision of medical knowledge, coping skills training | Behavioural | Psychological Intervention |
Primary outcome
KIDSCREEN: health-related quality of life
Time frame: baseline, 3 and 6 months post intervention
UCLA Child PTSD Reaction Index
Time frame: baseline, 3 and 6 months post intervention
DIKJ (Depression-Inventory for Children and Adolescents)
Time frame: baseline, 3 and 6 months post intervention
Child Behavior Checklist
Time frame: Baseline, 3 and 6 months post intervention
Spence Children's Anxiety Scale
Time frame: baseline, 3 and 6 months post intervention
2 secondary outcomes
Posttraumatic Distress Scale
Time frame: baseline, 3 and 6 months post intervention
Symptom Checklist 27
Time frame: baseline, 3 and 6 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- Results publication: PubMed 22236392Prchal A, Graf A, Bergstraesser E, Landolt MA. A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial. Child Adolesc Psychiatry Ment Health. 2012 Jan 11;6(1):3. doi: 10.1186/1753-2000-6-3.
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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.
Markus A Landolt, PhD principal investigator
University Children's Hospital Zurich, Psychosomatic and Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief psychological intervention in people with Cancer, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KIDSCREEN: health-related quality of life (time frame: baseline, 3 and 6 months post intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00296907, which also lists 1 linked publication.
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 30 Jul 2012.