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Improving Quality of Life of Children With Cancer Through Psychosocial Screening

2019년 10월 8일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

183

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 캐나다
    • British Columbia
      • Vancouver, British Columbia, 캐나다
        • BC Women and Children's Hospital
    • Ontario
      • Toronto, Ontario, 캐나다, M5V1X8
        • The Hospital for Sick Children

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

8년 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: Summary of psychosocial risk factors
The treatment team will receive a psychosocial risk summary shortly following diagnosis based on parent report.
활성 비교기: 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.
다른: Control
The treatment team will NOT receive a psychosocial risk summary shortly following diagnosis based on parent report.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline psychological distress at pediatric cancer diagnosis to six months later
기간: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)

2차 결과 측정

결과 측정
측정값 설명
기간
Change from baseline quality of life at pediatric cancer diagnosis to six months (Parent Self-Report)
기간: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Change from baseline distress at pediatric cancer diagnosis to six months following
기간: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Change from baseline family climate at pediatric cancer diagnosis to six months
기간: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Change from baseline quality of life at pediatric cancer diagnosis to six months (Self) report
기간: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Change from baseline quality of life at pediatric cancer diagnosis to six months (Proxy Report)
기간: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Pediatric Distress Thermometer
기간: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Pediatric Index of Emotional Distress (PI-ed)
기간: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
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.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

The Hospital for Sick Children

협력자

Provincial Health Services Authority

수사관

  • 수석 연구원: Maru Barrera, PhD, The Hospital for Sick Children

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2015년 6월 1일

기본 완료 (실제)

2017년 7월 31일

연구 완료 (실제)

2017년 7월 31일

연구 등록 날짜

최초 제출

2016년 5월 27일

QC 기준을 충족하는 최초 제출

2016년 6월 1일

처음 게시됨 (추정)

2016년 6월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 10월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 10월 8일

마지막으로 확인됨

2019년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 702843

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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