Quality of life and patient-reported outcomes after non-surgical management of early-stage endometrial cancer and endometrial hyperplasia with atypia: a long-term follow-up of the feMMe phase II randomized clinical trial
Abstract
Objective: Non-surgical, fertility-sparing management using a levonorgestrel intra-uterine device is a de-escalation strategy for selected patients with early-stage endometrial adenocarcinoma or endometrial hyperplasia with atypia. Although the oncologic outcomes of the feMMe trial have been reported, long-term patient-reported outcomes remain insufficiently characterized. This study evaluated long-term quality of life, self-efficacy, social support, and patient-reported experiences following conservative management.
Methods: The feMMe trial (open-label, randomized phase II study) includes three treatment arms: levonorgestrel intra-uterine device alone, levonorgestrel intra-uterine device plus weight loss, and levonorgestrel intra-uterine device plus metformin. Participants were contacted 15.8 to 130.2 months after trial entry. Quality of life was assessed using the Functional Assessment of Cancer Therapy-General questionnaire. Self-efficacy and social support regarding physical activity and diet were evaluated using the Self-Efficacy and Social Support questionnaire. Post-treatment experiences were collected using structured self-report items. Analyses were descriptive and included non-parametric group comparisons and correlation analyses.
Results: Forty-four participants completed long-term follow-up questionnaires. After a median follow-up of 63 months, overall quality of life was favorable; the mean (standard deviation) Functional Assessment of Cancer Therapy-General…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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