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临床试验/NCT04132856
NCT04132856已完成不适用

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

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2017年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Feasibility pertaining to recruitment

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Feasibility pertaining to recruitment

时间窗: 12 months

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

Feasibility pertaining to retention

时间窗: 12 months

Rates of completed questionnaires at all time points

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

时间窗: 12 months

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).

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

时间窗: 12 months

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?"

次要结局

  • Distress(Change from baseline to 12 months)
  • Patient generic quality of life based on self report(Change from baseline to 12 months)
  • Patient anxiety and depression - child/teem self report(Change from baseline to 12 months)
  • Patient anxiety (child/teen self-report)(Change from baseline to 12 months)
  • Psychosocial risk(Change from baseline to 12 months)
  • Financial impact of pediatric cancer diagnosis and treatment on families.(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)
  • Patient depression (child/teen self-report)(Change from baseline to 12 months)
  • Caregiver post-traumatic stress related to child's cancer diagnosis(Change from baseline to 12 months)
  • Patient post-traumatic stress related to own cancer diagnosis(Change from baseline to 12 months)
  • Caregiver coping with stress of child's cancer diagnosis(Change from baseline to 12 months)
  • Patient's own coping with stress of cancer diagnosis(Change from baseline to 12 months)
  • Caregiver depression(Change from baseline to 12 months)
  • Caregiver anxiety(Change from baseline to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maru Barrera

Principal Investigator

The Hospital for Sick Children

研究点 (2)

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