Mapping Psychosocial Screening to Services for Children With Cancer

NCT ID: NCT04132856

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-27
• Study Completion Date: 2020-04-30

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Psychosocial Navigator

Intervention Type: OTHER

Services of psychosocial navigator

Communication of Summary Profile

Intervention Type: OTHER

Both patient/caregiver dyad and HCPs will receive a summary of the PAT results and levels of depression and anxiety.

Treatment as Usual Group

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Psychosocial Navigator

Services of psychosocial navigator

Intervention Type: OTHER

Communication of Summary Profile

Both patient/caregiver dyad and HCPs will receive a summary of the PAT results and levels of depression and anxiety.

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Maru Barrera

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maru Barrera, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

Canadian Cancer Society's Advisory Committee on Cancer Statistics. Canadian Cancer Statistics 2015. Toronto, ON: Canadian Cancer Society; 2015.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 21810623 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21855719 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25752970 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17609228 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24106172 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19343796 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26715054 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34274016 (View on PubMed)

Other Identifiers

1000056445

Identifier Type: -

Identifier Source: org_study_id