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Not yet recruiting NCT07581093

The REACT Study: REhabilitation and ACTivity in Allogenic Transplant

Observational Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Longitudinal Study of Physical Function in Patients Undergoing Allogenic Stem Cell Transplant.

Overview

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.

Primary outcome measures

  • 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).]
  • 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).]
Secondary outcome measures (9)
  • 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).]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Nil

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07581093 · REACT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗