Acute myeloid leukaemia (AML) Cancer
Conditions
Interventions
Current interventions as of 22/10/2025:
PROPEL is a multicentre, randomised controlled trial comparing best practice usual care (BPUC) with a personalised prehabilitation care package (PPCP) incorpor
70-5
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 22/10/2025: 1. Age = 16 years, treated on adult AML pathway 2. Diagnosis of either AML or MDS-EB2 (MDS with =10% blasts in the bone marrow) following first diagnosis or disease relapse 3. In complete morphological remission (defined as <5% blasts in bone marrow) 4. Planned to receive either: 4.1. Intensive treatment (e.g. anthracycline/cytarabine-based chemotherapy) and/or HSCT, or lower intensity treatment (i.e. Venetoclax-based treatment) with HSCT – Pathway 1 Or 4.2. Planned to receive lower intensity treatment without HSCT (e.g. Venetoclax or Ivosidenib-based treatment)- Pathway 2 5. Before, or within the 1stcourse of treatment following remission 6. Planned to receive at least one further full cycle of treatment (chemotherapy or HSCT) post randomisation 7. Access to the internet and an email address 8. Willing to use videoconferencing to undertake the appointments and sessions Previous key inclusion criteria: 1. Age =16 years, treated on adult AML pathway And either: 2. Diagnosis of either AML or MDS-EB2 (MDS with 10% blasts in the bone marrow) 3. In complete remission at the completion of induction chemotherapy (defined <5% blasts) 4. Intention to undertake consolidation treatment (chemotherapy +/- HSCT) *Patients undergoing venetoclax-based treatment are only eligible if an HSCT is planned OR 5. Relapsed AML who have achieved a further complete remission, with an intent to deliver further intensive consolidation treatment +/- HSCT 6. Access to the internet and an email address 7. Willing to use videoconferencing to undertake the appointments and sessions
Exclusion criteria
Exclusion criteria: Current key inclusion criteria as of 22/10/2025: 1. Diagnosis of Acute Promyelocytic Leukaemia 2. Undergoing single-agent Azacitidine, single-agent low-dose Cytarabine, Menin inhibitors or FLT3 inhibitors treatments without HSCT planned Previous key inclusion criteria: 1. Diagnosis of acute promyelocytic leukaemia 2. Undergoing non-intensive treatment (e.g. single-agent azacitidine, low-dose cytarabine)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 22/10/2025: Subjective levels of fatigue measured using Functional Assessment of Chronic Illness Therapy (FACIT-F) fatigue scale at baseline, following each cycle of treatment, 3 months post EOT and up to 24 months post randomisation. For participants receiving long-term lower intensity treatment, this will be collected at baseline, following each cycle of treatment up to cycle 3, 3 months post end of cycle 3 and up to 24 months post randomisation. Previous primary outcome measure: Subjective levels of fatigue measured using Functional Assessment of Chronic Illness Therapy (FACIT-F) fatigue scale at baseline, following each cycle of treatment, 3 months post EOT and 24 months post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 22/10/2025: 1. Emotional wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline, following each cycle of treatment, 3 months post EOT/ 3months post end of cycle 3 and up to 24 months post randomisation 2. Anxiety and depression measured using the Patient Health Questionnaire 9-item (PHQ-9) and General Anxiety Disorder 7-item (GAD7) at baseline, following each cycle of treatment, 3 months post EOT/ 3months post end of cycle 3 and up to 24 months post randomisation 3. Health-related quality of life measured using FACIT-F and EQ-5D-5L at baseline, following each cycle of treatment, 3 months post EOT/ 3months post end of cycle 3 and up to 24 months post randomisation 4. Physical function measured using Karnofsky Performance Scale and IPAQ-SF at baseline, following each cycle of treatment, 3 months post EOT/ 3months post end of cycle 3 and up to 24 months post randomisation 5. Physical function measured using the 6-minute walk test at baseline, 3 months post EOT/ 3months post end of cycle 3 and up to 24 months post randomisation 6. Physical function measured using the hand grip strength test at baseline, EOT/End of cycle 3, 3 months post EOT/ 3months post end of cycle 3 and up to 24 months post randomisation 7. Presence or absence of sarcopenia measured using SARC-F and calf circumference at baseline, EOT/End of cycle 3, 3 months post EOT/ 3months post end of cycle 3 and up to 24 months post randomisation 8. Incidence of malnutrition and its determinants measured using MUST, percentage weight change; BMI at baseline, following each cycle of treatment, 3 months post EOT/ 3months post end of cycle 3 and up to 24 months post randomisation 9. Incidence of malnutrition and its determinants measured using dietary intake from a food diary at baseline, following each cycle of treatment and 3 months post EOT/ 3months post end of cycle 3 10. Completion of treatment cycles assessed using the number of cy | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed