Purpose
Although over 60% of patients with hematologic cancer report distressing fatigue, they often do not receive recommendations on fatigue management strategies. The aim of this pilot study was to estimate the feasibility of therapeutic education and physical activity (TEPA) by measuring the patients’ adherence to this multidimensional intervention. The secondary aim was to estimate the impact of TEPA on clinical outcomes.
Methods
Patients with hematologic cancer participated in this single-center, open-label, randomized controlled trial. The control group (CG) received two educational group sessions on fatigue and physical activity. The experimental group (EG) received the two educational sessions plus six weekly individual sessions aimed at implementing a personalized physical exercise program. Follow-ups were at 1, 3, and 7 months.
Results
Forty-six patients referred to chemotherapy were included, corresponding to 54% of recruitment rate. Adherence reached 90% in the EG and 68% in the CG. Most patients (65% in EG and 64% in CG) attended a minimum of 80% of the planned sessions. Overall retention rate was 87% (85% in EG and 91% in CG). No adverse events were registered. No between-group differences were detected in fatigue (FACIT-F), psychological distress (NCCN Distress Thermometer), QoL (EORTC QLQ-C30), or functional exercise capacity (TUG test and 6MWT). Adherence to an active lifestyle, measured by a semi-structured interview, increased from 56.5 to 84% in the EG at 7 months (p = 0.02), whereas it decreased slightly in the CG (from 47.8 to 42.9%).
Conclusion
Multidimensional rehabilitation interventions are feasible and safe in this population, and larger trials should focus on the efficacy of such approaches on clinically relevant outcomes.
Trial registration
ClinicalTrials.gov Identifier: NCT03403075.