PROPEL: Evaluation of PeRsOnalised PrEhabilitation in people with acute myeloid Leukaemia
Chief Investigator: Professor Janet Dunn & Professor Simon Stanworth
Sponsor: University Hospitals Coventry and Warwickshire
Funder: National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme
Registration Number: TBC
Background: Cancer-related fatigue due to disease and treatment is a universal feature and major
symptomatic burden for people with acute myeloid leukaemia (AML); it may be associated with states of
anorexia, cachexia and sarcopenia and persist for many months during and after treatment. Emerging data
support fatigue prior to and during chemotherapy as a prognostic marker for poorer outcomes.
‘Prehabilitation’ aims to improve psychological and physical wellbeing to help people with AML get through
the intensive chemotherapy treatment courses including haemopoietic stem cell transplant (HSCT), often
the critical therapy-providing cure. We wish to understand whether a package of enhanced personalised
prehabilitation can help people with AML cope better with treatment, with less fatigue, compared to
prehabilitation care that happens now (usual care). The PROPEL trial has been designed with major input
from patient groups and will shape care by helping patients and clinicians make informed choices about
preparing for intensive chemotherapy/HSCT.
Aim: To establish the clinical impact and cost-effectiveness of ’best practice usual prehabilitation care’
(BPUC) compared to a multiphasic, multimodal personalised prehabilitation care package (PPCP) on fatigue,
emotional wellbeing and quality of life (QoL) in patients receiving remission consolidation treatment for AML
or high-risk myelodysplastic syndromes with excess blasts (MDS-EB2).
Design: Multicentre, 1:1 randomised controlled trial comparing BPUC with PPCP incorporating a
12-month internal pilot, parallel process evaluation and economic evaluation
Control Vs Intervention:
Best Practice Usual Care (BPUC): Participants will be provided with standard materials (online or
printed prehabilitation information on emotional wellbeing, nutrition, and physical activity) and
participate in a 30-minute call with a member of the remote research team prior to the first cycle of
consolidation chemotherapy. The local healthcare professional (HCP) will liaise with participant to
book this appointment but will not be required to attend.
Personalised Prehabilitation Care Package (PPCP): Participants will be provided with a 4-component
care package delivered centrally with support from the local HCP prior to each course of
consolidation chemotherapy and HSCT (if given), providing information and tailored support for
emotional wellbeing, nutrition and physical activity
600 patients across 50 NHS sites.
Primary & Secondary outcomes:
To compare fatigue measured by the Functional Assessment of Chronic Illness Therapy (FACIT-F) fatigue scale in patients having consolidation chemotherapy +/- HSCT for AML or high risk MDS-EB2 receiving best practice usual care (BPUC) or personalised prehabilitation care package (PPCP).
To compare between arms:
- Emotional wellbeing, QoL, distress, physical function, performance status, weight change, macronutrient intake
- Number of completed chemotherapy and HSCT treatment courses
- Onward referrals for ‘specialist’ services
- Overall and relapse-free survival, deaths in CR
- To conduct a parallel process evaluation to understand the implementation and functioning of the intervention in context
- To determine the cost, cost-effectiveness, and cost utility, of PPCP in comparison to BPUC.
September 2022 to 31st August 2027.
FPFV (First patient first visit) expected early 2023 with a recruitment period of 30months.