The REACT Study: REhabilitation and ACTivity in Allogenic Transplant
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Dublin, Trinity College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who are listed for allogeneic stem cell transplant.
Ability to provide written informed consent
Over 18 years old
Disqualifiers
Nil
Trial population
Patients undergoing allogeneic stem cell transplant.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
140 Participants
are grouped into 1 trial groupGroup A: Patients undergoing haematopoeitic stem cell transplant
Trial outcomes
Primary outcomes
1
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.
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
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)
Time frame
Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).Secondary outcomes
1
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.
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
Change in Muscle Strength
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).3
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.
Time frame
Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).4
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
Time frame
Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).Other outcomes
1
Qualitative Feedback
Interviews with patients exploring the impact of cancer treatment, including HSCT, on physical function.
Time frame
Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Dublin, Trinity College
Lead sponsor
Health Research Board, Ireland
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: