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

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): BPUC is in addition to prehabilitation care received as
standard practice at site. It involves a 30-minute virtual prehabilitation discussion with a member of the central team, the participant +/- their caregiver where appropriate, once only and prior to the first cycle of consolidation chemotherapy. The participant will be provided with online or printed generic and freely available prehabilitation information on emotional wellbeing, nutrition, and physical activity.

Personalised Prehabilitation Care Package (PPCP): PCP is in addition to prehabilitation care received as
standard practice at site. It involves information plus personalised support for emotional wellbeing, nutrition and physical activity. It will be offered before each consolidation cycle of chemotherapy and HSCT, if given. The PPCP will be developed based on screening and assessment of the person with AML by a central team of prehabilitation experts, with input from local staff and a caregiver (if appropriate). The PPCP will include advice on nutrition, physical activity and managing emotional well-being as required. Additionally, participants will be offered a range of remote support sessions delivered by a central specialist team (psychological wellbeing practitioners with clinical psychologist supervision, Clinical Exercise physiologist/physiotherapist/ Can-REHAB coaches and dietitians). Local staff will be trained to provide on-going behavioural support to participants via regular check-ins, to encourage adherence to the intervention. PPCP will mirror each consolidation cycle of chemotherapy and HSCT.

600 patients across 50 NHS sites.

Primary outcome:

• 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).

Secondary Outcomes:

Secondary objectives of the trial are to compare between arms:

• Emotional wellbeing, QoL, distress, physical function, performance status,
  incidence of malnutrition and sarcopenia.
• Number of completed chemotherapy and HSCT treatment cycles
• Onward referrals for ‘specialist’ services.
• Overall and relapse-free survival
• To conduct a parallel process evaluation to understand the implementation and
  functioning of the intervention in context
• To assess whether the intervention works through the intended mechanisms of
  action
• To determine the cost, cost-effectiveness, and cost-utility, of PPCP in comparison to
  BPUC.

1st September 2022 to 31st August 2027

Recruitment period of 30months (31st August 2025)