Skip to content

A realist evaluation of nutritional prehabilitation in adults with acute myeloid leukaemia receiving chemotherapy and or stem cell transplantation

Why, for whom and under what circumstances, does nutritional prehabilitation work (or not) to reduce malnutrition in adults with acute myeloid leukaemia receiving chemotherapy and or stem cell transplantation: a realist evaluation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14938999
Enrollment
160
Registered
2026-01-05
Start date
2025-11-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional prehabilitation in adults with acute myeloid leukaemia receiving chemotherapy and/or stem cell transplantation Cancer

Interventions

Data from a retrospective case note review of dietetic care and cancer treatment
Service delivery materials, Realist interviews of people with AML and their carers to understand their experiences and observations of services will build evidence-informed programme theory. There is

Sponsors

Nottingham University Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient: 1. Diagnosis of either AML or MDS-EB2 (MDS with =10% blasts in the bone marrow), or In remission post induction chemotherapy with a plan for further treatment 2. Age =16 years, treated on adult AML pathway 3. Receiving active chemotherapy: 3.1. High intensity chemotherapy 3.2. Venetoclax-Azacytidine or 3.3. Azacitidine alone. 3.4. And/or stem cell transplant/ CAR-T therapy 4. Accessed nutritional care as a single prehabilitation intervention or part of multimodal prehabilitation programme Carer: Family member or friend, who has provided unpaid* caring duties to a patient (as above) who received nutritional care as part one of the prehabilitation programmes across the 3 case studies. * this does not preclude those who receive carers benefits from the government.

Exclusion criteria

Exclusion criteria: Patient: 1. Acute promyelocytic leukaemia 2. Age = 16 years old Or = 16 years and treated in a paediatric or Teenage and Young Adult Unit (*Due to the different service provision in these settings) 3. Receiving immunotherapy only OR Not on active treatment e.g. best supportive care interventions such as blood and platelet transfusions only. 4. Received no nutritional care as a single prehabilitation intervention or part of multimodal programme prior to treatment Carer: Carer participants: Family member, friend or health professional who has provided paid* caring duties to a patient (as above) who received nutritional care as part one of the prehabilitation programmes across the three case studies. * this does not include those who receive a carers allowance from the government but are doing it in an employed capacity.

Design outcomes

Primary

MeasureTime frame
Retrospective data is collected from patient records on the their nutritional/dietetic care received, cancer treatment and dates of interventions / treatments. A purposive sample of participants (Patients and carers) are invited to interview to discuss their experiences of nutritional prehabilitation services and how they work, for whom and in what context (via realist interviews). Services are observed (observation diaries) to understand how they are working. All data is pulled together to develop evidence informed programme theories that seek to explain why, for whom and under what circumstances, personalised oral nutrition interventions within prehabilitation for chemotherapy work (or not) in adults with AML. Evidence informed statements describe how different contexts trigger different responses/processes in people or systems (mechanisms) to produce different effects (outcomes) e.g. malnutrition risk or dietary quality.

Secondary

MeasureTime frame
The outcomes of the programme theory will be achieved by exploring the following collated from retrospective analysis of patient participant health care records during chemotherapy (between diagnosis and stem cell transplantation) and realist interviews (after treatment) and observational diaries of services delivering prehab. Outcomes include: 1. The intended and unintended outcomes of nutrition interventions in different groups of people, e.g.: 1.1. Incidence of malnutrition as measured by validated tools e.g. MUST or diagnostic consensus criteria e.g. GLIM criteria; including % weight change, body mass index, dietary intake (macro and micronutrient), estimated nutritional requirements, presence or absence of sarcopenia, anorexia and/or inflammation, and demographic data (ethnicity, socio-deprivation index, age, sex) 2. Barriers or facilitators to dietary interventions: 2.1. Presence or absence of nutritional impact symptoms e.g nausea, diarrhoea 2.2. Patient and carer experiences of barriers and facilitators via realist interviews 3. Adherence to dietary recommendations/intervention; e.g. nutritional supplement intake, no. of dietetic contacts (planned vs delivered), diet adherence e.g. Mediterranean Diet adherence score (MEDAS) or difference in nutrient intake versus estimated requirements/recommended daily intakes (RDI) 4. Mechanisms by which nutrition interventions interplay with other prehabilitation constituents, where delivered within a multimodal programme (realist interviews/observational diaries) 5. If there are different responses or contextual features required for different people with AML to reduce inequalities in access to these nutritional prehabilitation interventions (realist interviews and retrospective data analysis of medical notes and observations)

Countries

England, United Kingdom

Contacts

Public ContactLaura J Miller
laura.miller44@nhs.net+44 7968294708

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026