Clinical trial NCT04132856: Mapping Psychosocial Screening to Services for Children With Cancer
Official title: Mapping Psychosocial Screening to Services for Children With Cancer: Feasibility and Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: pediatric
oncology
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
First posted: 2019-10-21
Enrollment: 38
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility pertaining to recruitment
timeFrame: 12 months
measure: Feasibility pertaining to retention
timeFrame: 12 months
measure: Satisfaction with Enhanced Intervention as assessed by questionnaire at completion of study
timeFrame: 12 months
measure: Satisfaction with Enhanced Intervention as assessed by semi-structured interview at completion of study
timeFrame: 12 months
Secondary outcomes:
measure: Distress
timeFrame: Change from baseline to 12 months
measure: Patient generic quality of life based on self report
timeFrame: Change from baseline to 12 months
measure: Patient generic quality of life based on caregiver report
timeFrame: Change from baseline to 12 months
measure: Patient quality of life as it relates to cancer, based on self-report
timeFrame: Change from baseline to 12 months
measure: Patient quality of life as it relates to cancer, based on caregiver report
timeFrame: Change from baseline to 12 months
measure: Patient anxiety and depression - child/teem self report
timeFrame: Change from baseline to 12 months
measure: Patient anxiety (child/teen self-report)
timeFrame: Change from baseline to 12 months
measure: Patient depression (child/teen self-report)
timeFrame: Change from baseline to 12 months
measure: Caregiver post-traumatic stress related to child's cancer diagnosis
timeFrame: Change from baseline to 12 months
measure: Patient post-traumatic stress related to own cancer diagnosis
timeFrame: Change from baseline to 12 months
measure: Caregiver coping with stress of child's cancer diagnosis
timeFrame: Change from baseline to 12 months
measure: Patient's own coping with stress of cancer diagnosis
timeFrame: Change from baseline to 12 months
measure: Psychosocial risk
timeFrame: Change from baseline to 12 months
measure: Financial impact of pediatric cancer diagnosis and treatment on families.
timeFrame: Change from baseline to 12 months
measure: Caregiver depression
timeFrame: Change from baseline to 12 months
measure: Caregiver anxiety
timeFrame: Change from baseline to 12 months
Other outcomes:
measure: Sleep duration and quality of sleep of patient and caregiver
timeFrame: Change from baseline to 12 months
measure: Caregiver emotional support
timeFrame: Change from baseline to 12 months
measure: Caregiver Fatigue
timeFrame: Change from baseline to 12 months
measure: Patient Peer Relationships
timeFrame: Change from baseline to 12 months
measure: Patient Fatigue
timeFrame: Change from baseline to 12 months
measure: Patient emotional support
timeFrame: Change from baseline to 12 months
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Maru Barrera, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Canadian Cancer Society's Advisory Committee on Cancer Statistics. Canadian Cancer Statistics 2015. Toronto, ON: Canadian Cancer Society; 2015.
citation: Pinquart M, Shen Y. Behavior problems in children and adolescents with chronic physical illness: a meta-analysis. J Pediatr Psychol. 2011 Oct;36(9):1003-16. doi: 10.1093/jpepsy/jsr042. Epub 2011 Aug 1.
citation: Kurtz BP, Abrams AN. Psychiatric aspects of pediatric cancer. Pediatr Clin North Am. 2011 Aug;58(4):1003-23, xii. doi: 10.1016/j.pcl.2011.06.009.
citation: Kazak AE, Schneider S, Didonato S, Pai AL. Family psychosocial risk screening guided by the Pediatric Psychosocial Preventative Health Model (PPPHM) using the Psychosocial Assessment Tool (PAT). Acta Oncol. 2015 May;54(5):574-80. doi: 10.3109/0284186X.2014.995774. Epub 2015 Mar 9.
citation: Pai AL, Patino-Fernandez AM, McSherry M, Beele D, Alderfer MA, Reilly AT, Hwang WT, Kazak AE. The Psychosocial Assessment Tool (PAT2.0): psychometric properties of a screener for psychosocial distress in families of children newly diagnosed with cancer. J Pediatr Psychol. 2008 Jan-Feb;33(1):50-62. doi: 10.1093/jpepsy/jsm053. Epub 2007 Jul 3.
citation: Barrera M, Hancock K, Rokeach A, Cataudella D, Atenafu E, Johnston D, Punnett A, Nathan PC, Bartels U, Silva M, Cassidy M, Jansen P, Shama W, Greenberg C. External validity and reliability of the Psychosocial Assessment Tool (PAT) among Canadian parents of children newly diagnosed with cancer. Pediatr Blood Cancer. 2014 Jan;61(1):165-70. doi: 10.1002/pbc.24774. Epub 2013 Sep 17.
citation: McCarthy MC, Clarke NE, Vance A, Ashley DM, Heath JA, Anderson VA. Measuring psychosocial risk in families caring for a child with cancer: the Psychosocial Assessment Tool (PAT2.0). Pediatr Blood Cancer. 2009 Jul;53(1):78-83. doi: 10.1002/pbc.22007.
citation: Sint Nicolaas SM, Schepers SA, Hoogerbrugge PM, Caron HN, Kaspers GJ, van den Heuvel-Eibrink MM, Grootenhuis MA, Verhaak CM. Screening for Psychosocial Risk in Dutch Families of a Child With Cancer: Reliability, Validity, and Usability of the Psychosocial Assessment Tool. J Pediatr Psychol. 2016 Aug;41(7):810-9. doi: 10.1093/jpepsy/jsv119. Epub 2015 Dec 29.
citation: Desjardins L, Hancock K, Szatmari P, Alexander S, Shama W, De Souza C, Mills D, Abla O, Barrera M. Protocol for mapping psychosocial screening to resources in pediatric oncology: a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Jul 17;7(1):143. doi: 10.1186/s40814-021-00878-0.