- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02489071
Cognitive Intervention After a Brain Tumor
연구 개요
상세 설명
Cognitive impairments (including problems with attention, memory or executive functions) are common in people with brain tumors, as a result of the disease and/or treatment effects. These deficits, even when relatively mild, can interfere with interpersonal relationships, occupational activities, functional independence, and quality of life. They may also contribute to caregiver burden.
Building on research in other cognitively-impaired populations, in this study we compare two behavioural interventions. The Brain Training (BT) and Brain Health (BH) interventions each offer a structured yet client-centered program through 8 weekly individual treatment sessions and between-session exercises. Contents include mindfulness practice, strategy training, and supportive psychoeducation including counseling around lifestyle factors to promote brain functioning.
Using a prospective randomized controlled design, 54 brain tumor patients are being enrolled in one of three study arms: BT, BH, or standard care (wait-list control). A battery of outcome measures is being administered (1) prior to intervention, (2) after the 8-week behavioural intervention (or wait-list) period, and (3) after an additional 4 months to evaluate longer-term outcomes. Analyses of variance will examine treatment effects, with regression analyses to explore moderating effects of participant demographics, severity of baseline cognitive impairment, and tumor and treatment factors (e.g., tumor location, radiation dose and distribution). Results of this trial will lay the groundwork for implementation of evidence-based supportive care to reduce and manage cognitive impairments following a brain tumor.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5S1W8
- Princess Margaret Cancer Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- age 18 or older
- fluent in English
- able to provide informed consent to all procedures
- diagnosis of a brain tumor
- indication of lasting post-treatment cognitive deficits (e.g., from clinical presentation, prior neuropsychological assessment, and/or self-report)
- sufficient motor and sensory functioning to complete study activities
- availability to complete all study activities
- for patients treated with cranial radiation, at least 3 months post-radiation
Exclusion Criteria:
(1) comorbid neurological or psychiatric disorder or other medical condition suspected to influence cognition
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Brain Training
8-session cognitive training program
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실험적: Brain Health
8-session cognitive education program
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간섭 없음: 제어
대기자 명단 제어 그룹
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in cognitive composite score
기간: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Summation of standardized change scores on neuropsychological tests
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baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in functional composite score
기간: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Summation of standardized change scores on measures of occupational functioning
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baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Change in quality of life composite score
기간: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Summation of standardized change scores on measures of affect, perceived self-efficacy, and illness burden
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baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Change in caregiver quality of life composite score
기간: baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Summation of standardized change scores on measures of affect and caregiver burden
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baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kim Edelstein, PhD, Princess Margaret Cancer Centre, University Health Network
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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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