Improving Quality of Life of Children With Cancer Through Psychosocial Screening
2019年10月8日 更新者：Maru Barrera、The Hospital for Sick Children
Improving Quality of Life of Children With Cancer Through Psychosocial Screening and Improved Communication in Health Care Providers
In Canada, approximately 1450 children are diagnosed with cancer annually.
Diagnosis of childhood cancer and its aggressive treatment can have devastating psychosocial effects on the whole family (e.g.
unpleasant feelings or emotions that impact your daily activities).
It is not known whether health care providers who treat these children use and value psychosocial tools or how beneficial the use of these tools is for these families.
This research team will test the benefits of using psychosocial screening on the quality of life of treated children, parents and siblings.
調査の概要
詳細な説明
In Canada approximately 1450 children are diagnosed with cancer annually.
Childhood cancer diagnosis and treatment can have devastating psychosocial effects on the family.
Tools to screen for psychosocial risks (PSR) in pediatric oncology are rare.
Our preliminary work adapted the Psychosocial Assessment Tool (PAT) for the Canadian population, PATrevised (PATrev), and developed the Psychosocial Care Checklist (PCCL).
The PATrev is completed by parents of children with cancer, and yields a summary of the psychosocial needs of the patient, parents, and siblings.
The PCCL assesses HCPs knowledge of family's psychosocial needs and services.
Importantly, psychosocial screening is associated with reduced parental anxiety and improved child's quality of life (QOL).
Demonstration of the tool's ability to maximize patient and family psychosocial outcomes is needed.
Participants will be parents of children newly diagnosed with cancer, (patients and siblings (> 8 years), if available).
Design: RCT with concealed allocation to experimental group (EG) and control group (CG), with repeated measures (after diagnosis= T1, 6 months later=T2).
The EG treating team will receive a summary of PATrev risk information based on parent report.
No risk information will be provided in the CG.
Parents in both groups will complete the PATrev, family environment questionnaire, self--report and proxy reported QoL, distress and mood measures for the patient and one sibling.
Patients and siblings will self-report on QOL, distress and mood.
Patient charts will be reviewed (T2) to determine treatment intensity and documented psychosocial services for each family.
研究の種類
介入
入学 (実際)
183
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
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British Columbia
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Vancouver、British Columbia、カナダ
- BC Women and Children's Hospital
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Ontario
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Toronto、Ontario、カナダ、M5V1X8
- The Hospital for Sick Children
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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
8年～100年 (子、大人、高齢者)
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:
- Parents of children newly diagnosed with cancer, within 2 to 4 weeks post-diagnosis.
- Siblings of children newly diagnosed with cancer, within 2-4 weeks post-diagnosis, between the ages of 8 years and 16 years, able to complete outcome measures, without a physical chronic condition.
- Children with cancer, newly diagnosed, within 2 to 4 weeks post-diagnosis, between the ages of 8 and 16 years, able to complete outcome measures.
Exclusion Criteria:
- Parents of children not diagnosed with cancer.
- Sibling of children not diagnosed with cancer
- Children not diagnosed with cancer.
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Experimental Group
Participants in this arm will have a summary of their family's psychosocial risk factors provided to the treatment team.
This will occur twice: once shortly after diagnosis (within 2-4 weeks) and once approximately 6 months following diagnosis.
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The treatment team will receive a psychosocial risk summary shortly following diagnosis based on parent report.
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アクティブコンパレータ：Control Group
Participants in this arm will NOT have a summary of their family's psychosocial risk factors provided to the treatment team shortly after diagnosis.
However, the risk factors will be distributed to the treatment team 6 months following diagnosis.
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The treatment team will NOT receive a psychosocial risk summary shortly following diagnosis based on parent report.
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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 |
|---|---|---|
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Change from baseline psychological distress at pediatric cancer diagnosis to six months later
時間枠：T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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Measured by Hospital Anxiety and Depression Scale (HADS).
A standardized measure of symptoms of anxiety and depression in adults.
The HADS is suitable for all ages from 17+.
The HADS consists of 14 questions, which are ranked according to a 4 point Likert type scale.
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T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline quality of life at pediatric cancer diagnosis to six months (Parent Self-Report)
時間枠：T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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Measured by Caregiver Quality of Life Scale (CQOLC), 35 items using a five-point Likert-type scale to assess QoL in the family caregiver of cancer patients.
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T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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Change from baseline distress at pediatric cancer diagnosis to six months following
時間枠：T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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Measured by the Distress Thermometer, a standardized screening tool for measuring emotional distress in adults.
Has been widely used as a screening tool of distress in adult cancer patients and caregivers.
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T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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Change from baseline family climate at pediatric cancer diagnosis to six months
時間枠：T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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Measured by Family Environment Scale (FES), a standardized measure of social climate within the family.
The FES is a self-report measure which contains 27 true/false statements.
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T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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Change from baseline quality of life at pediatric cancer diagnosis to six months (Self) report
時間枠：T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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Measured by Pediatric Quality of Life (PedsQL 4.0) - Cancer Module, Standardized tool measures child/parent perceptions of a child's health-related quality of life specific to having cancer.
Self report and parent proxy perception of health-related quality of life across 8 domains: pain, nausea, procedure, and treatment anxiety, worry, cognition, physical and commutation.
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T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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Change from baseline quality of life at pediatric cancer diagnosis to six months (Proxy Report)
時間枠：T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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Measured by Pediatric Quality of Life (PedsQL 4.0) - Generic Module.The measure assesses perception for the child's general health across global, physical, emotional , social and academic domains.
Parent/self report by healthy sibling
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T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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Pediatric Distress Thermometer
時間枠：T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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Standardized screening tool for measuring emotional distress in children.
The distress thermometer adapted for pediatric population.
Participants self-report on their distress on a line drawing representation of a thermometer.
For this age group, distress is defined as worry, anxiety, sadness and fear on a visual analog scale from 0 (no distress) to 5 (moderate distress) to 10 (high distress).
For patient with cancer and healthy sibling.
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T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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Pediatric Index of Emotional Distress (PI-ed)
時間枠：T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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A 14-item self-report measure of emotional distress in children rated on a 4-point Likert scale (0 = not at all; 3 = always).
This measure, based on the Hospital Anxiety and Depression Scale (HADS;[62]), was designed to differentiate symptoms of emotional distress from physical illness in pediatric populations.
It comprises two subscales assessing depression and anxiety, which when summated, provides a global index of emotional distress.
For child with Cancer and healthy sibling.
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T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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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
- Barrera M, D'Agostino NM, Gibson J, Gilbert T, Weksberg R, Malkin D. Predictors and mediators of psychological adjustment in mothers of children newly diagnosed with cancer. Psychooncology. 2004 Sep;13(9):630-41. doi: 10.1002/pon.765.
- Boman K, Lindahl A, Bjork O. Disease-related distress in parents of children with cancer at various stages after the time of diagnosis. Acta Oncol. 2003;42(2):137-46. doi: 10.1080/02841860310004995.
- Kazak AE, Simms S, Rourke MT. Family systems practice in pediatric psychology. J Pediatr Psychol. 2002 Mar;27(2):133-43. doi: 10.1093/jpepsy/27.2.133.
- Sawyer MG, Antoniou G, Toogood I, Rice M, Baghurst PA. A prospective study of the psychological adjustment of parents and families of children with cancer. J Paediatr Child Health. 1993 Oct;29(5):352-6. doi: 10.1111/j.1440-1754.1993.tb00533.x.
- Wijnberg-Williams BJ, Kamps WA, Klip EC, Hoekstra-Weebers JE. Psychological distress and the impact of social support on fathers and mothers of pediatric cancer patients: long-term prospective results. J Pediatr Psychol. 2006 Sep;31(8):785-92. doi: 10.1093/jpepsy/jsj087. Epub 2005 Oct 26.
- Woodgate RL, Degner LF, Yanofsky R. A different perspective to approaching cancer symptoms in children. J Pain Symptom Manage. 2003 Sep;26(3):800-17. doi: 10.1016/s0885-3924(03)00285-9.
- Kupst MJ, Natta MB, Richardson CC, Schulman JL, Lavigne JV, Das L. Family coping with pediatric leukemia: ten years after treatment. J Pediatr Psychol. 1995 Oct;20(5):601-17. doi: 10.1093/jpepsy/20.5.601.
- Kazak AE, Brier M, Alderfer MA, Reilly A, Fooks Parker S, Rogerwick S, Ditaranto S, Barakat LP. Screening for psychosocial risk in pediatric cancer. Pediatr Blood Cancer. 2012 Nov;59(5):822-7. doi: 10.1002/pbc.24166. Epub 2012 Apr 10.
- 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.
- Patel SK, Mullins W, Turk A, Dekel N, Kinjo C, Sato JK. Distress screening, rater agreement, and services in pediatric oncology. Psychooncology. 2011 Dec;20(12):1324-33. doi: 10.1002/pon.1859. Epub 2010 Oct 5.
- Barrera M, Young MA, Hancock K, Chung J. Early trajectory of psychosocial risk in families of children and adolescents newly diagnosed with cancer. Support Care Cancer. 2022 Feb;30(2):1815-1822. doi: 10.1007/s00520-021-06581-3. Epub 2021 Oct 4.
- Barrera M, Alexander S, Atenafu EG, Chung J, Hancock K, Solomon A, Desjardins L, Shama W, Mills D. Psychosocial screening and mental health in pediatric cancer: A randomized controlled trial. Health Psychol. 2020 May;39(5):381-390. doi: 10.1037/hea0000825. Epub 2020 Jan 23.
- Barrera M, Hancock K, Atenafu E, Alexander S, Solomon A, Desjardins L, Shama W, Chung J, Mills D. Quality of life in pediatric oncology patients, caregivers and siblings after psychosocial screening: a randomized controlled trial. Support Care Cancer. 2020 Aug;28(8):3659-3668. doi: 10.1007/s00520-019-05160-x. Epub 2019 Dec 6.
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)
2015年6月1日
一次修了 (実際)
2017年7月31日
研究の完了 (実際)
2017年7月31日
試験登録日
最初に提出
2016年5月27日
QC基準を満たした最初の提出物
2016年6月1日
最初の投稿 (見積もり)
2016年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月10日
QC基準を満たした最後の更新が送信されました
2019年10月8日
最終確認日
2019年10月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 702843
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