Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)
Conditions
Keywords
Stem Cell Transplantation, Physical Functional Performance, Physical Activity
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University of Dublin, Trinity College
Health Research Board, Ireland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are listed for allogeneic stem cell transplant. * Ability to provide written informed consent * Over 18 years old
Exclusion criteria
* Nil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Function | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 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). | 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 |
| Change in Fatigue Levels | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). | Multidimensional Fatigue Inventory score. A higher score means more fatigue / worse fatigue-related impact |
| Change in Psychosocial Wellbeing | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). | Hospital Anxiety Depression Scale. Scores range from 0-21 with higher scores meaning greater psychological distress. |
| Health Economics | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). | 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). |
| Change in Body Composition | Pre-treatment (T0), 3 months post-transplant (T2). | Bioelectrical Impedance. Measures of fat mass will be recorded (% body fat). |
| Change in functional strength | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). | 30 second sit to stand. Number of repetitions will be recorded, with higher scores indicate better strength. |
| Change in Aerobic Fitness | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). | 2 minute step test. Number of repetitions completed in 2 minutes will be recorded. A higher score indicates better aerobic endurance and cardiovascular fitness. |
| Change in Physical Activity Levels | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). | Godin Questionnaire. A a Leisure-Time Exercise Score (LTEQ) will be recorded for each participant. Higher scores indicate greater levels of physical activity. |
| Change in Muscle Strength | Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4). | Grip Strength in kg's where higher values indicate greater overall muscle strength |
Contacts
CONTACTGrainne Sheill, PhD
Outcome results
None listed