The REACT Study: REhabilitation and ACTivity in Allogenic Transplant (REACT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

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 Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Grainne Sheill, PhD; Phone Number: +353 879403733; Email: sheillg@tcd.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing allogeneic stem cell transplant.

Description

Inclusion Criteria:

• Patients who are listed for allogeneic stem cell transplant.
• Ability to provide written informed consent
• Over 18 years old

Exclusion Criteria:

• Nil

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients undergoing haematopoeitic stem cell transplant; Patients who are listed for allogeneic stem cell transplant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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).
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).

Other Outcome Measures

Outcome Measure	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).

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Collaborators: Health Research Board, Ireland

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 28, 2029
• Study Completion (Estimated): December 28, 2029

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Stem Cell Transplantation; Physical Functional Performance
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: REACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No