The REACT Study: REhabilitation and ACTivity in Allogenic Transplant (REACT)
A Longitudinal Study of Physical Function in Patients Undergoing Allogenic Stem Cell Transplant.
연구 개요
상태
상세 설명
Current treatments for haematological cancers are associated with improved survival rates, however they are also associated with significant toxicity and long periods of hospitalization, which may negatively affect patients' quality of life and physical performance. Hematopoeitic stem cell transplant (HSCT) is a potentially curative treatment option however remains a high-toxicity treatment with a high risk of severe complications. The optimal format of rehabilitation needed by patients undergoing HSCT is unclear.
A prospective, longitudinal cohort study will be conducted to evaluate the effects of treatment on patients undergoing HSCT. The objectives are this study are: (1) to investigate the impact of HSCT on physical performance, quality of life and fatigue before and over 12 months from HSCT; (2) to investigate the effect of pre-transplantation factors associated with outcomes post HSCT and identify potentially modifiable factors; (3) to compare changes in outcomes between older (aged ≥60 years) and younger (18-59 years) patients.
Overall this project will determine the impact of treatment on the physical performance of patients undergoing HSCT.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Grainne Sheill, PhD
- 전화번호: +353 879403733
- 이메일: sheillg@tcd.ie
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
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샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients who are listed for allogeneic stem cell transplant.
- Ability to provide written informed consent
- Over 18 years old
Exclusion Criteria:
- Nil
공부 계획
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디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Patients undergoing haematopoeitic stem cell transplant
Patients who are listed for allogeneic stem cell transplant.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Physical Function
기간: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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The Short Physical Performance Battery will be used to assess physical function. Scores range from 0 to 12, with higher scores indicating better physical performance and functional mobility. |
Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Change in Physical Function
기간: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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The World Health Organization Disability Schedule 2.0 will be used to assess any change in health and disability. A 12-item version will be used with each item rated on a 5-point Likert scale Higher scores indicate greater disability ie. minimum: 12 (no disability) and maximum: 60 (complete/extreme disability) |
Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Aerobic Fitness
기간: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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2 minute step test.
Number of repetitions completed in 2 minutes will be recorded.
A higher score indicates better aerobic endurance and cardiovascular fitness.
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Change in Muscle Strength
기간: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Grip Strength in kg's where higher values indicate greater overall muscle strength
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Change in Physical Activity Levels
기간: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Godin Questionnaire.
A a Leisure-Time Exercise Score (LTEQ) will be recorded for each participant.
Higher scores indicate greater levels of physical activity.
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Change in Quality of Life
기간: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Functional Assessment of Cancer Therapy - Bone Marrow Transplant.
This is a valid and reliable patient reported outcome measure of five dimensions of quality of life in bone marrow transplant patients.
A higher FACT-BM scores indicate better health-related quality of life
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Change in Fatigue Levels
기간: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Multidimensional Fatigue Inventory score.
A higher score means more fatigue / worse fatigue-related impact
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Change in Psychosocial Wellbeing
기간: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Hospital Anxiety Depression Scale.
Scores range from 0-21 with higher scores meaning greater psychological distress.
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Health Economics
기간: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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EQ-5D-5L and measures of healthcare utilisation.
A health utility index score will be recorded (Higher index score = better health-related quality of life).
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Change in Body Composition
기간: Pre-treatment (T0), 3 months post-transplant (T2).
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Bioelectrical Impedance.
Measures of fat mass will be recorded (% body fat).
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Pre-treatment (T0), 3 months post-transplant (T2).
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Change in functional strength
기간: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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30 second sit to stand.
Number of repetitions will be recorded, with higher scores indicate better strength.
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Qualitative Feedback
기간: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Interviews with patients exploring the impact of cancer treatment, including HSCT, on physical function.
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
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처음 게시됨 (실제)
연구 기록 업데이트
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추가 정보
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