Aims: Endometrial cancer is associated with the highest burden of comorbid disease of any form of cancer. The aim of this trial was to assess the feasibility and safety of an allied health lifestyle intervention during adjuvant treatment.
Methods: pilot randomised (2:1) controlled trial with concealed allocation and assessor-blinding. Eligibility criteria included: scheduled to receive adjuvant treatment following surgery for endometrial cancer, disease stage I-IIIC1, ECOG 0-2 and able to participate in an unsupervised exercise program. Participants received usual care and 8 sessions of weekly, individualised, lifestyle education (diet, physical activity) with behaviour change and social support (intervention group), delivered predominantly by telehealth, or usual care alone. Feasibility outcomes included recruitment and consent rate, decline reasons, program acceptability, adherence and retention at follow-up assessments. Secondary measures assessed at baseline, 9 weeks and 3 months included physical activity, nutrition and health-related quality of life.
Results: 22/44 eligible patients (50%, 95%CI: 36%, 64%) were recruited over 10 months (14 intervention, 8 usual care). The recruitment rate was 2.2 patients/month (95%CI: 1.4, 3.3). Most patients who declined had too much going on (7/22, 32%) or were not interested (6/22, 27%). Mean age and BMI were 63.2 years (SD=6.8) and 31.9 kg/m2(SD=6.7), respectively. A majority were FIGO stage I (15/22, 68%) and received vaginal brachytherapy alone (14/22, 64%). Adherence was high, 11/14 (79%, 95%CI: 52%, 92%) participants attended >70% of scheduled sessions. Participants reported being well supported with 2/14 (14%) taking up social work intervention following initial assessment. Retention was 100% (95%CI: 85%, 100%) at 9 weeks, but completion of objective nutrition measures was impacted by COVID-19 restrictions. There were no serious adverse events.
Conclusions: Additional recruitment sites are required for a larger RCT. The majority of participants were of early disease stage and did not require social support during treatment.