Mapping Psychosocial Screening to Services for Children With Cancer
Condition: Cancer
Study type: Interventional

Summary: 
      Children with cancer are vulnerable to symptoms of anxiety and depression. Although screening
      for psychosocial distress is a standard of care for children with cancer, there is a limited
      knowledge
    

Detailed description: 
      Background: Approximately 3 000 children and adolescents are diagnosed with cancer in Canada
      each year [Canadian Cancer Society]. Children with cancer experience higher rates of anxiety
      and depression symptoms relative to healthy controls [Pinquart & Shen, 2011], and a subgroup
      are vulnerable to marked levels of psychological distress [Kurtz & Abrams, 2011]. One
      standard for psychosocial care in pediatric cancer that is starting to be implemented across
      the United Stated and Canada is the systematic screening for psychosocial distress, using the
      Psychosocial Assessment Tool (PAT) [Kazak, Schneider, Didonato, Pai, 2015; Pai et al., 2008;
      Barrera et al., 2014; McCarthy et al., 2009; Sint Nicolaas et al., 2016]. However, a dearth
      of literature exists on how to bridge screening for psychosocial distress and the delivery of
      appropriate evidence-based mental health resources. The current study is a randomized
      controlled pilot intervention project which aims to test the feasibility and effects of
      introducing a psychosocial navigator who will coordinate the delivery of psychosocial
      resources to children with cancer and their families based on early screening and follow-up
      for psychosocial distress. Specific Objectives: 1) To determine the feasibility and utility
      of conducting psychosocial screening and providing an Enhanced Psychosocial Intervention
      (EPSI). 2) To examine the effects of EPSI, as compared to treatment as usual (TAU+), on the
      mental health, quality of life, coping, and social relationships of children with cancer.
      Methods: A randomized controlled feasibility intervention trial, with a TAU+ control group,
      will be conducted with newly diagnosed children with any type of cancer. Participants will be
      10-18 years of age, medically suitable for participation, in active treatment, and the
      primary caregiver. Forty-eight child-caregiver dyads (24 in the intervention and 24 in the
      control group) will be enrolled. The EPSI will have two components: 1) Information about the
      psychosocial risk of the family and mental health of the child (e.g., depression) and 2) the
      Psychosocial Navigator (PSN) as resource for tailoring psychosocial resources to child-family
      distress, linking with the treating team. Measures of feasibility (recruitment,
      acceptability) will be documented throughout; initial screening using the PAT will be
      conducted 2-4 weeks post diagnosis (baseline); and using the distress thermometer, follow-up
      will be done at specific periods depending on the disease (leukemia/lymphoma, solid tumors,
      brain tumors). The primary psychosocial outcome (depression), and secondary outcomes
      (post-traumatic stress, pain, fatigue, coping, sleep quality, time and financial cost, social
      support and quality of life) will be completed at baseline and 12 months later. Descriptive
      statistics (frequency and percentage rates) will be provided for feasibility measures and PAT
      psychosocial risk categories. Means, standard deviations, and ranges will be provided for the
      primary and secondary outcomes. Preliminary analyses of group comparisons will also be
      performed via independent t tests and chi square tests. Further, analyses of covariance
      (ANCOVAs) will be conducted on the primary and secondary outcomes to test group differences
      at post-test while controlling for pretest scores.

      Significance: The proposed intervention project will assess and address the psychosocial
      needs of newly diagnosed pediatric cancer patients and families. This intervention aims to
      improve the triaging of resources and enhance the effectiveness of psychosocial intervention
      for children with cancer. The enhanced intervention is expected to improve children's and
      adolescents' coping with disease-related stressors such as pain and uncertainty, improve
      their mood, and enhance social engagement with peers.
    

Intervention name(s): Psychosocial Navigator; Communication of Summary Profile
Intervention type(s): Other; Other
Intervention description(s): Services of psychosocial navigator; Both patient/caregiver dyad and HCPs will receive a summary of the PAT results and levels of depression and anxiety.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: pediatric; oncology