PROPEL: Evaluation of PeRsOnalised PrEhabilitation in people with acute myeloid Leukaemia

Study ID: 56018
Short Title: PROPEL
Trust Name: SFT
Recruitment Site: Salisbury District Hospital
Disease Area: Haematology
Phase: N/A
Expected End Date: 31/08/2025
Postcode: SP2 8BJ
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

• Age > = 16 years, treated on adult AML pathway And either: o Diagnosis of either AML or MDS-EB2 (MDS with 10% blasts in the bone marrow) o In complete remission at completion of induction chemotherapy (defined < 5% blasts) o Intention to undertake consolidation treatment (chemotherapy +/- HSCT), * Patients undergoing Venetoclax based treatment are only eligible if a HSCT is planned. OR o Relapsed AML who have achieved a further complete remission, with an intent to deliver further intensive consolidation treatment +/- HSCT. • Access to the internet and an email address • Willing to use videoconferencing to undertake the appointments and sessions.

• Diagnosis of Acute Promyelocytic Leukaemia • Undergoing non-intensive treatment (e.g. single agent azacitidine, low dose cytarabine).

Acute myeloid leukaemia (AML), is an ‘aggressive’ blood cancer with only around 20% of affected adults surviving at 5 years. AML often presents as a medical emergency and treatment is intensive. After the initial course of urgent anticancer therapy, people with AML receive repeated intensive courses of chemotherapy aimed at cure, that may include ‘haemopoietic’ (blood) stem cell transplantation. They need to remain in hospital during courses of treatment, often in isolation, due to risk of infection, with short periods at home to recover. This treatment often has huge detrimental effects on physical, nutritional and mental health. Fatigue is the most debilitating problem for people with AML, and often continues into recovery. ‘Prehabilitation’ aims to improve physical and psychological wellbeing after diagnosis, to help people with AML get through treatment and stem cell transplants which are often critical for cure. The study will test whether a package of enhanced personalised prehabilitation can help people with AML cope better with treatment, with less fatigue, compared to the current best practice of prehabilitation care (best practice usual care). ‘PROPEL’, will involve 600 people treated for AML, who will be randomised to either: 1. Best practice usual care: a 30-minute appointment with a member of the central team, given once, before the first chemotherapy course to signpost to relevant resources on psychological health, nutrition and physical activity. 2. A ‘prehabilitation’ care package: A 60minute appointment with a central team of specialists to tailor a personalised care plan for psychological wellbeing, nutrition and physical activity before each chemotherapy and stem cell transplant. Participants will also have access to range of remote sessions with specialists.

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