Assessing the Efficacy of a Psychosocial Intervention Program for Siblings of Children With Cancer
Condition: Cancer
Study type: Interventional

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
      brother's or sister's 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 Children's Hospital, BC Women and Children's 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.
    

Intervention name(s): Control Group; Experimental Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Sessions will not be designed around a specific theme related to childhood cancer and sibling relationships. Activities and games will not have a specific focus. CG sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.; The experimental group will be detailed, session by session, in the manual written for this purpose. It addresses on topic per session (respecting each other, medical information about cancer, family relationships, sibling's fears and feelings, relationship between siblings, relationships at school, generating hope.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric cancer; psychosocial; siblings