Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)REACTNCT07581093
The REACT Study: REhabilitation and ACTivity in Allogenic Transplant
An observational study of Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT), run by University of Dublin, Trinity College.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 28 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing allogeneic stem cell transplant.
Who may be able to join
- Patients who are listed for allogeneic stem cell transplant.
- Ability to provide written informed consent
- Over 18 years old
Who cannot join
- Nil
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Longitudinal Study of Physical Function in Patients Undergoing Allogenic Stem Cell Transplant.
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.
Read the 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.
- Keywords
- Stem Cell Transplantation, Physical Functional Performance, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing haematopoeitic stem cell transplant | Patients who are listed for allogeneic stem cell transplant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
Secondary outcomes (9)
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.
Measured: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
Change in Muscle Strength
Grip Strength in kg's where higher values indicate greater overall muscle strength
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 May 2026 (estimated)
- Primary completion28 Dec 2029 (estimated)
- Study completion28 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Principal investigator, Grainne Sheill, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581093
- Sponsor's protocol ID
- REACT
- Acronym
- REACT
- Status last verified
- May 2026
- First submitted
- 26 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of Physical Function in Patients Undergoing Allogenic Stem Cell Transplant.
- ClinicalTrials.gov ID
- NCT07581093
- Acronym / sponsor ID
- REACT / REACT
- Keywords
- Stem Cell Transplantation, Physical Functional Performance, Physical Activity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 28 Dec 2029 (estimated)
- Study completion
- 28 Dec 2029 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing haematopoeitic stem cell transplant | – | –Patients who are listed for allogeneic stem cell transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing allogeneic stem cell transplant.
Key inclusion criteria (3 listed)
- Patients who are listed for allogeneic stem cell transplant.
- Ability to provide written informed consent
- Over 18 years old
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in 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).
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.
Change in 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).
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)
9 secondary outcomes
Change in Aerobic 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).
Change in 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).
Change in Physical Activity Levels
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
Health Economics
Time frame: 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
Time frame: Pre-treatment (T0), 3 months post-transplant (T2).
Change in functional 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT), run by University of Dublin, Trinity College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grainne Sheill, PhD (+353 879403733, sheillg@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.