Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02787330
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2016-05-09
Brief Title:
Assessing the Efficacy of a Psychosocial Intervention Program for Siblings of Children With Cancer
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Assessing the Efficacy of a Psychosocial Intervention Program for Siblings of Children With Cancer
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The psychosocial effects of childhood cancer and its demanding medical treatment can affect not only the ill child but the whole family particularly siblings who are often overlooked given the terrible circumstances these families face Current evidence suggests that negative long-term psychosocial effects of childhood cancer may be more severe in siblings than in the child with cancer Addressing these effects on siblings may benefit the child with cancer and the entire family Thus early psychosocial preventive interventions are needed to foster psychosocial adjustment in siblings and promote better quality of life for the entire family The immediate objective of this study is to address siblings psychological distress by assessing feasibility and efficacy of a manualized group intervention for siblings of children with cancer Siblings Coping Together SibCT A longer term objective is that the evidence-based intervention could then be exported to other centres across Canada and internationally Additionally the study results will identify biomedical personal familial and social determinants of intervention outcomes that can guide clinical effort for those at greatest risk Finally the overall aim of the project is to reduce psychological distress and improve quality of life for siblings and families impacted by a cancer diagnosis and its demanding treatment
Detailed Description:
Siblings of children with cancer can endure great psychological distress as a result of their brothers or sisters diagnosis and treatment Understandably when a child has cancer their parents attention is focused mainly on that child and therefore the siblings needs may not be fully addressed Thus siblings often develop feelings of anger abandonment jealousy and fear which may lead to an increased risk for academic difficulties symptoms of depression and anxiety and post traumatic stress disorder although the results are not consistent across studies Of most concern is that psychological problems may persist through adulthood as suggested by a recent study in which alcoholism was more prevalent among siblings of children with cancer when compared to peers and cancer survivors Therefore it is imperative to develop evidence based psychological intervention programs to prevent these detrimental psychological effects in siblings of children with cancer This project aims to address siblings psychological distress by assessing the efficacy of a manualized group intervention for siblings of children with cancer SibCT across three Canadian sites SickKids Alberta Childrens Hospital BC Women and Childrens Hospital using a randomized control trial RCT experimental design A manualized intervention is considered the gold standard for psychological intervention as it ensures replicability of the study and intervention fidelity The primary aim is to demonstrate that survivors in the SibCT group EG demonstrate decreased symptoms of depression and anxiety improve their overall quality of life compared to an attention control group CG A secondary aim is to show that compared to CG EG will show improvements in secondary measures of quality of life as well as knowledge about cancer We will also explore other factors such as disease and treatment variables social contextual variables individual sibling variables and family variables Randomized Control Trial design with repeated measures will be used Siblings of children on active cancer treatment and at least 3 months from diagnosis to reduce parental burden between 8-16 years of age will be included in the study Siblings will be randomized to either the EG or CG Approximately 184 siblings will be recruited across the three pediatric centres After baseline assessment both groups will have 8 two-hour weekly group sessions consisting of arts and crafts and games and two post-intervention assessments at the end of session 8 and three months later In the EG the critical ingredient has education and social and therapeutic problem solving components based on the manual Examples of weekly session topics include age-appropriate medical information about cancer siblings fears and feelings relationships at school etc The CG will not have any education or therapeutic-based components Rigorous testing of the efficacy of an intervention program is a critical step for developing evidence-based treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None