Mapping Psychosocial Screening to Services for Children With Cancer

Cancer Clinical Trial

Official title:

Mapping Psychosocial Screening to Services for Children With Cancer: Feasibility and Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04132856
• Other study ID #: 1000056445
• Status: Completed
• Phase: N/A
• Start date: November 27, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: October 2020
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Psychosocial Navigator
Services of psychosocial navigator
• Communication of Summary Profile
Both patient/caregiver dyad and HCPs will receive a summary of the PAT results and levels of depression and anxiety.

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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. — View Citation

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

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. — View 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. — View 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. — View Citation

Pai AL, Patiño-Fernández 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. Epub 2007 Jul 3. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep duration and quality of sleep of patient and caregiver	Pittsburgh Sleep Quality Index. (Caregiver and patient self-report). Minimum value is 0. Maximum value is 21. Lower scores indicate better sleep quality.	Change from baseline to 12 months
Other	Caregiver emotional support	Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support Questionnaire (caregiver self-report). Minimum score is 6. Maximum score is 30. Higher scores indicate higher levels of emotional support.	Change from baseline to 12 months
Other	Caregiver Fatigue	Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Questionnaire (caregiver self-report). Minimum score is 6. Maximum score is 30. Lower scores indicate lower levels of fatigue	Change from baseline to 12 months
Other	Patient Peer Relationships	Patient-Reported Outcomes Measurement Information System (PROMIS) Perceived Quality of Peer Relationships (child/teen self-report). Minimum score is 8. Maximum score is 40. Higher scores indicate higher levels of perceived peer relationship quality.	Change from baseline to 12 months
Other	Patient Fatigue	Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Questionnaire (child/teen self-report). Minimum score is 10. Maximum score is 50. Lower scores indicate lower levels of fatigue.	Change from baseline to 12 months
Other	Patient emotional support	Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support Questionnaire (child/teen self-report). Minimum score is 7. Maximum score is 35. Higher scores indicate higher levels of emotional support.	Change from baseline to 12 months
Primary	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
Primary	Feasibility pertaining to retention	Rates of completed questionnaires at all time points	12 months
Primary	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
Primary	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	Distress	Pediatric and Adult Distress Thermometer (self-report) measures participant distress on a visual analog scale of 1 to 10, with a score of 10 indicating high distress	Change from baseline to 12 months
Secondary	Patient generic quality of life based on self report	Pediatric Quality of Life - generic. (Child/teen self-report). Measures perceived quality of life of child with cancer based on self perception - on everyday items (for children who do not have cancer). Miinimum score is 0. Maximum score is 100. Higher score indicates better perceived quality of life.	Change from baseline to 12 months
Secondary	Patient generic quality of life based on caregiver report	Pediatric Quality of Life - generic. (Caregiver-report). Measures perceived quality of life of child with cancer based on caregiver perception - on everyday items (for children who do not have cancer). Miinimum score is 0. Maximum score is 100. Higher score indicates better perceived quality of life.	Change from baseline to 12 months
Secondary	Patient quality of life as it relates to cancer, based on self-report	Pediatric Quality of Life-Cancer (Child/teen self-report). Measures perceived quality of life of child with cancer based on self-perception. Miinimum score is 0. Maximum score is 100. Higher score indicates better perceived quality of life.	Change from baseline to 12 months
Secondary	Patient quality of life as it relates to cancer, based on caregiver report	Pediatric Quality of Life-Cancer (Caregiver report). Measures perceived quality of life of child with cancer based on caregiver perception. Miinimum score is 0. Maximum score is 100. Higher score indicates better perceived quality of life.	Change from baseline to 12 months
Secondary	Patient anxiety and depression - child/teem self report	Pediatric Index of Emotional Distress. Minimum score is 0. Maximum score is 42. Lower score indicates lower levels of anxiety and depression.	Change from baseline to 12 months
Secondary	Patient anxiety (child/teen self-report)	Patient-reported Outcomes Measurement Information System (PROMIS) - pediatric anxiety questionnaire - short form (child/teen self-report). Minimum score is 8. Maximum score is 40. Lower score indicates lower level of anxiety.	Change from baseline to 12 months
Secondary	Patient depression (child/teen self-report)	Patient-reported Outcomes Measurement Information System (PROMIS) - pediatric depression questionnaire - short form (child/teen self-report). Minimum score is 8. Maximum score is 40. Lower score indicates lower level of depression.	Change from baseline to 12 months
Secondary	Caregiver post-traumatic stress related to child's cancer diagnosis	Impact of Events scale - Revised (IES-R) (caregiver self-report). Mimimum score is 0. Maximum score is 88. Lower scores indicate lower levels of post-traumatic stress.	Change from baseline to 12 months
Secondary	Patient post-traumatic stress related to own cancer diagnosis	Impact of Events scale - Revised (IES-R) (child/teen self-report). Mimimum score is 0. Maximum score is 88. Lower scores indicate lower levels of post-traumatic stress.	Change from baseline to 12 months
Secondary	Caregiver coping with stress of child's cancer diagnosis	Responses to Stress Questionnaire - Cancer Version (caregiver self-report). Minimum score is 0. Maximum score is 1. A higher score indicates more engagement with active coping strategies.	Change from baseline to 12 months
Secondary	Patient's own coping with stress of cancer diagnosis	Response to Stress Questionnaire - Cancer Version (patient self-report). Minimum score is 0. Maximum score is 1. A higher score indicates more engagement with active coping strategies.	Change from baseline to 12 months
Secondary	Psychosocial risk	Psychosocial Assessment Tool (PAT) (caregiver report). Minimum score is 0. Maximum score is 3. Lower score indicates lower level of psychosocial risk.	Change from baseline to 12 months
Secondary	Financial impact of pediatric cancer diagnosis and treatment on families.	Financial burden questionnaire (caregiver report). Minimum score is 22. Maximum score is 88. Higher score indicates lower level of financial impact on families.	Change from baseline to 12 months
Secondary	Caregiver depression	Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire (caregiver self-report). Minimum score is 6. Maximum score is 30. Lower scores indicate lower levels of depression.	Change from baseline to 12 months
Secondary	Caregiver anxiety	Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Questionnaire (caregiver self-report). Minimum score is 6. Maximum score is 30. Lower scores indicate lower levels of anxiety.	Change from baseline to 12 months