NutriPREHAB (Ver 1.0)
Research type
Research Study
Full title
Why, for whom and under what circumstances, personalised oral nutrition interventions within prehabilitation for chemotherapy work (or not) in adults with AML?
IRAS ID
329722
Contact name
Laura Miller
Contact email
Sponsor organisation
Nottingham University Hospitals
Clinicaltrials.gov Identifier
303577, NIHR (Funder)
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
Background: Less than 15% of adults with acute myeloid leukaemia (AML) survive 5-years, following diagnosis and a third will be malnourished at diagnosis. Treatment is intensive chemotherapy with or without a haematopoietic cell transplant (H and being malnourished worsens treatment outcomes. Studies in other cancer populations show that personalised dietary programmes given alone or as part of a package before treatment - called 'prehabilitation' may help. However, studies in AML are limited and programme outcomes vary.
Aim: To test and refine a programme theory that supports understanding of why, for whom, and under what circumstances personalised oral nutrition interventions during prehabilitation work or not for adults with AML receiving chemotherapy.
Potential benefit: The programme theory will support understanding of why participant response to nutritional prehabilitation programmes may vary and provide insight into future considerations for design and delivery to support inclusive and accessible programmes.
Methods: Mixed methods realist evaluation, composed of 3 phases.
* Phase 1: Initial programme theory (IPT) development utilising mixed methods (guidelines review a realist synthesis (PROSPERO registration no: CRD42024552814), alongside stakeholder and patient and public involvement group consultation) - Ongoing
* Phase 2: Testing our understanding - Use different types of data to test IPTs against real world data from people with AML, their carers and services. e.g. nutrition & clinical outcome (Patient data), service data and patient (n=15-20) & carer (n=5-10 interviews) from 3 different nutrition prehabilitation case studies delivered in different contexts.
* Phase 3: Refining our understanding: Integrated analysis of phase 2 data to test IPTs checked and refined in collaboration with PPI and stakeholder working groups.PPI/Stakeholders: A patient and public group n=4 (people with lived experience and community inclusion group representation) alongside a stakeholder group n=8-9 consisting of clinicians, academics, charities and policy experts in prehabilitation, nutrition, AML and psychosocial context to ensure relevance in UK NHS setting.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
25/PR/0543
Date of REC Opinion
17 Jun 2025
REC opinion
Further Information Favourable Opinion