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Mapping Psychosocial Screening to Services for Children With Cancer

2020年10月20日 更新者:Maru Barrera、The Hospital for Sick Children

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

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

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

38

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Ontario
      • Toronto、Ontario、カナダ、M4G 3R9
        • Hospital for Sick Children

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

10年~18年 (子、大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ふるい分け
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
Services of psychosocial navigator
Both patient/caregiver dyad and HCPs will receive a summary of the PAT results and levels of depression and anxiety.
介入なし: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).

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Feasibility pertaining to recruitment
時間枠: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
12 months
Feasibility pertaining to retention
時間枠:12 months
Rates of completed questionnaires at all time points
12 months
Satisfaction with Enhanced Intervention as assessed by questionnaire at completion of study
時間枠: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).
12 months
Satisfaction with Enhanced Intervention as assessed by semi-structured interview at completion of study
時間枠: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?"
12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Distress
時間枠:Change from baseline to 12 months
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
Patient generic quality of life based on self report
時間枠:Change from baseline to 12 months
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
Patient generic quality of life based on caregiver report
時間枠:Change from baseline to 12 months
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
Patient quality of life as it relates to cancer, based on self-report
時間枠:Change from baseline to 12 months
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
Patient quality of life as it relates to cancer, based on caregiver report
時間枠:Change from baseline to 12 months
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
Patient anxiety and depression - child/teem self report
時間枠:Change from baseline to 12 months
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
Patient anxiety (child/teen self-report)
時間枠:Change from baseline to 12 months
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
Patient depression (child/teen self-report)
時間枠:Change from baseline to 12 months
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
Caregiver post-traumatic stress related to child's cancer diagnosis
時間枠:Change from baseline to 12 months
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
Patient post-traumatic stress related to own cancer diagnosis
時間枠:Change from baseline to 12 months
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
Caregiver coping with stress of child's cancer diagnosis
時間枠:Change from baseline to 12 months
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
Patient's own coping with stress of cancer diagnosis
時間枠:Change from baseline to 12 months
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
Psychosocial risk
時間枠:Change from baseline to 12 months
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
Financial impact of pediatric cancer diagnosis and treatment on families.
時間枠:Change from baseline to 12 months
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
Caregiver depression
時間枠:Change from baseline to 12 months
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
Caregiver anxiety
時間枠:Change from baseline to 12 months
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

その他の成果指標

結果測定
メジャーの説明
時間枠
Sleep duration and quality of sleep of patient and caregiver
時間枠:Change from baseline to 12 months
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
Caregiver emotional support
時間枠:Change from baseline to 12 months
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
Caregiver Fatigue
時間枠:Change from baseline to 12 months
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
Patient Peer Relationships
時間枠:Change from baseline to 12 months
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
Patient Fatigue
時間枠:Change from baseline to 12 months
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
Patient emotional support
時間枠:Change from baseline to 12 months
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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Maru Barrera, PhD、The Hospital for Sick Children

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年11月27日

一次修了 (実際)

2020年4月30日

研究の完了 (実際)

2020年4月30日

試験登録日

最初に提出

2019年10月10日

QC基準を満たした最初の提出物

2019年10月16日

最初の投稿 (実際)

2019年10月21日

学習記録の更新

投稿された最後の更新 (実際)

2020年10月22日

QC基準を満たした最後の更新が送信されました

2020年10月20日

最終確認日

2020年10月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 1000056445

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いいえ

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いいえ

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