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Randomized Controlled Trial
. 2022 Jan-Dec:21:15347354211069885.
doi: 10.1177/15347354211069885.

ENhAncing Lifestyle Behaviors in EndometriaL CancEr (ENABLE): A Pilot Randomized Controlled Trial

Lara Edbrooke  1   2 , Pearly Khaw  1   2 , Alison Freimund  1   2 , Danielle Carpenter  1 , Orla McNally  2   3 , Lynette Joubert  1   2 , Jenelle Loeliger  1 , Anya Traill  1 , Karla Gough  1   2 , Linda Mileshkin  1   2 , Linda Denehy  1   2
Affiliations
Randomized Controlled Trial

ENhAncing Lifestyle Behaviors in EndometriaL CancEr (ENABLE): A Pilot Randomized Controlled Trial

Lara Edbrooke et al. Integr Cancer Ther. 2022 Jan-Dec.

Abstract

Purpose: Endometrial cancer is associated with the highest comorbid disease burden of any cancer. The aim of this trial was to assess the feasibility and safety of an allied health intervention during adjuvant treatment.

Methods: A mixed-methods pilot randomized (2:1) controlled trial with concealed allocation and assessor-blinding. Eligibility criteria: adjuvant endometrial cancer treatment scheduled, disease stage I-IIIC1, ECOG 0-2 and able to perform unsupervised physical activity (PA). Participants received usual care and 8 sessions of weekly, individualized, lifestyle education (diet and PA) with behavior change and social support (intervention group), delivered predominantly by telehealth, or usual care alone. Feasibility outcomes: recruitment and consent rates, decline reasons, program acceptability, intervention adherence and retention.

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). Patients who declined had too much going on (7/22, 32%) or were not interested (6/22, 27%). Mean (SD) age and BMI were 63.2 years (6.8) and 31.9 kg/m2 (6.7). A majority were FIGO stage I (15/22, 68%) and received vaginal brachytherapy (14/22, 64%). Adherence was high, 11/14 (79%, 95%CI: 52%, 92%) participants attended >70% of scheduled sessions. Retention was 100% (95%CI: 85%, 100%) at 9 weeks, however completion of objective measures was impacted by COVID-19 restrictions. Telehealth and online questionnaires enabled participation. No serious adverse events occurred.

Conclusion: The intervention was acceptable to participants with high levels of adherence and retention. Trial findings will be used to design a future RCT.

Trial registration: The trial was registered on www.anzctr.org.au (ACTRN12619000631101) 29/04/2019.

Keywords: endometrial cancer; nutrition; physical activity; telehealth.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Trial objective and patient-reported outcomes.
Figure 2.
Figure 2.
Participant flow through the trial.
See this image and copyright information in PMC

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