Mapping Psychosocial Screening to Services for Children With Cancer

The Hospital for Sick Children

Status: Completed

Conditions: Cancer

Treatments: Other: Communication of Summary Profile; Other: Psychosocial Navigator

Study type: Interventional

Funder types: Other

Identifiers

NCT04132856

1000056445

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between 10 and 18 years of age
• Clinical diagnosis of cancer
• Less than 4 weeks since diagnosis disclosure
• Primary caregiver must also consent to participation

Exclusion criteria

• Cancer diagnosis disclosed more than 4 weeks ago.
• Primary caregiver declines to participate

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Intervention Group

Experimental group

Description:

The Intervention group will receive the services of the Psychosocial Navigator (PSN) monthly for the full 12 months of the study. At baseline, the PSN will provide the health care providers (HCPs) and family with recommendations for mapping and triaging of resources to levels of psychosocial risk (PAT: Universal, Targeted, Clinical) and level of depression and anxiety (mild, moderate, and high mental health problems; as determined by the standardized norms for the measures). This information will be summarized in the Communication Summary Profile and shared with the treating team (oncologist, nurse, and Social Worker, core psychosocial staff involved in the child's care) and family within 48 hours of completion. The PSN will conduct follow-up psychosocial screenings on a monthly basis, using the Distress Thermometer for children and caregivers. Results of the monthly assessments and recommended resources will also be communicated to the caregiver/parent and treating team of the youth.

Treatment:

Other: Psychosocial Navigator

Other: Communication of Summary Profile

Treatment as Usual Group

No Intervention group

Description:

Current psychosocial care services will be accessible to Treatment as Usual Group (e.g., social work, child life, psychology, art and music therapy, and psychiatry).