NCT Number: NCT07581093
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: Pre-treatment (T0), 3 months post-transplant (T2).
Bioelectrical Impedance. Measures of fat mass will be recorded (% body fat).
Time frame: 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.
Time frame: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
Interviews with patients exploring the impact of cancer treatment, including HSCT, on physical function.
Contact information is provided by the study sponsor or research team.
University of Dublin, Trinity College
Other
A Longitudinal Study of Physical Function in Patients Undergoing Allogenic Stem Cell Transplant.
Acronym: REACT
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