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| Name | Class |
|---|---|
| Health Research Board, Ireland | OTHER |
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A prospective, longitudinal cohort study will be conducted to evaluate the effects of treatment on the physical function of patients undergoing Allogeneic Hematopoeitic Stem Cell Transplant.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing haematopoeitic stem cell transplant | Patients who are listed for allogeneic stem cell transplant. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Function | 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). |
| Change in Physical Function | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Aerobic Fitness | 2 minute step test. Number of repetitions completed in 2 minutes will be recorded. A higher score indicates better aerobic endurance and cardiovascular fitness. | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Feedback | Interviews with patients exploring the impact of cancer treatment, including HSCT, on physical function. | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). |
Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing allogeneic stem cell transplant.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grainne Sheill, PhD | Contact | +353 879403733 | sheillg@tcd.ie |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Change in Muscle Strength |
Grip Strength in kg's where higher values indicate greater overall muscle strength |
| Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). |
| Change in Physical Activity Levels | Godin Questionnaire. A a Leisure-Time Exercise Score (LTEQ) will be recorded for each participant. Higher scores indicate greater levels of physical activity. | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). |
| Change in Quality of Life | 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 | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). |
| Change in Fatigue Levels | Multidimensional Fatigue Inventory score. A higher score means more fatigue / worse fatigue-related impact | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). |
| Change in Psychosocial Wellbeing | Hospital Anxiety Depression Scale. Scores range from 0-21 with higher scores meaning greater psychological distress. | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). |
| Health Economics | 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). | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). |
| Change in Body Composition | Bioelectrical Impedance. Measures of fat mass will be recorded (% body fat). | Pre-treatment (T0), 3 months post-transplant (T2). |
| Change in functional strength | 30 second sit to stand. Number of repetitions will be recorded, with higher scores indicate better strength. | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). |