The REACT Study: REhabilitation and ACTivity in Allogenic Transplant (REACT)
6. Mai 2026 aktualisiert von: Grainne Sheill, University of Dublin, Trinity College
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.
Studienübersicht
Status
Noch keine Rekrutierung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
140
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Grainne Sheill, PhD
- Telefonnummer: +353 879403733
- E-Mail: sheillg@tcd.ie
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Patients undergoing allogeneic stem cell transplant.
Beschreibung
Inclusion Criteria:
- Patients who are listed for allogeneic stem cell transplant.
- Ability to provide written informed consent
- Over 18 years old
Exclusion Criteria:
- Nil
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
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Patients undergoing haematopoeitic stem cell transplant
Patients who are listed for allogeneic stem cell transplant.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Physical Function
Zeitfenster: 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. |
Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
|
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Change in Physical Function
Zeitfenster: 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) |
Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Aerobic Fitness
Zeitfenster: 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.
|
Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Change in Muscle Strength
Zeitfenster: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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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).
|
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Change in Physical Activity Levels
Zeitfenster: 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.
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Change in Quality of Life
Zeitfenster: 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
|
Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
|
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Change in Fatigue Levels
Zeitfenster: 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
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
|
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Change in Psychosocial Wellbeing
Zeitfenster: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Hospital Anxiety Depression Scale.
Scores range from 0-21 with higher scores meaning greater psychological distress.
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Health Economics
Zeitfenster: Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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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).
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Change in Body Composition
Zeitfenster: Pre-treatment (T0), 3 months post-transplant (T2).
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Bioelectrical Impedance.
Measures of fat mass will be recorded (% body fat).
|
Pre-treatment (T0), 3 months post-transplant (T2).
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Change in functional strength
Zeitfenster: 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.
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Qualitative Feedback
Zeitfenster: 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.
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Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Mai 2026
Primärer Abschluss (Geschätzt)
28. Dezember 2029
Studienabschluss (Geschätzt)
28. Dezember 2029
Studienanmeldedaten
Zuerst eingereicht
26. März 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. Mai 2026
Zuerst gepostet (Tatsächlich)
12. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
12. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- REACT
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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