Mapping Psychosocial Screening to Services for Children With Cancer

NCT04132856 | Completed DMC

• 1 other identifier: 1000056445
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer

Keywords

pediatric; oncology

Outcome Measures

Primary Outcomes (4)

• Feasibility pertaining to recruitment

  Rate of recruitment as measured by percentage of participants who consent to participation as compared to those who are eligible and do not consent

  12 months

• Feasibility pertaining to retention

  Rates of completed questionnaires at all time points

  12 months

• Satisfaction with Enhanced Intervention as assessed by questionnaire at completion of study

  5 - point likert scale satisfaction questionnaire with 6 questions pertaining to usefulness and overall satisfaction with the enhanced intervention. The minimum score is 6 (low satisfaction) and the maximum score is 30 (high satisfaction).

  12 months

• Satisfaction with Enhanced Intervention as assessed by semi-structured interview at completion of study

  Semi-structured interview with 6 questions including "What were your expectations about being in this study?"; "Were your expectations of the study met?"; "Do you have any additional comments/suggestions for the study?"

  12 months

Secondary Outcomes (16)

• Distress

  Change from baseline to 12 months

• Patient generic quality of life based on self report

  Change from baseline to 12 months

• Patient generic quality of life based on caregiver report

  Change from baseline to 12 months

• Patient quality of life as it relates to cancer, based on self-report

  Change from baseline to 12 months

• Patient quality of life as it relates to cancer, based on caregiver report

  Change from baseline to 12 months

Other Outcomes (6)

• Sleep duration and quality of sleep of patient and caregiver

  Change from baseline to 12 months

• Caregiver emotional support

  Change from baseline to 12 months

• Caregiver Fatigue

  Change from baseline to 12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Psychosocial Navigator; Other: Communication of Summary Profile

Treatment as Usual Group

NO INTERVENTION

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).

Interventions

Psychosocial Navigator OTHER

Services of psychosocial navigator

Intervention Group

Communication of Summary Profile OTHER

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

Intervention Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Centre for Addiction and Mental Health: collaborator

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M4G 3R9, Canada

Location

Related Publications (9)

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

  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.

  PMID: 21810623 BACKGROUND

• 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.

  PMID: 21855719 BACKGROUND

• 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.

  PMID: 25752970 BACKGROUND

• 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.

  PMID: 17609228 BACKGROUND

• 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.

  PMID: 24106172 BACKGROUND

• 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.

  PMID: 19343796 BACKGROUND

• 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.

  PMID: 26715054 BACKGROUND

• 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.

  PMID: 34274016 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Maru Barrera, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 21, 2019
• Study Start: November 27, 2017
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)