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

Objective Non-surgical, fertility-sparing management using a levonorgestrel intrauterine device represents a de-escalation strategy for selected patients with early-stage endometrial adenocarcinoma or endometrial hyperplasia with atypia. While oncologic outcomes of the feMMe trial are established, long-term patient-reported outcomes remain insufficiently characterized. This study aimed to evaluate 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 intrauterine device alone, levonorgestrel intrauterine device plus weight loss, and levonorgestrel intrauterine device plus metformin. Participants were contacted between 15.8–130.2 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 by structured self-report. Analyses were descriptive, with non-parametric group comparisons, and correlation analyses. Results 44 participants completed long-term follow-up questionnaires. After a median of 63 months, overall quality of life was favorable, with a mean Functional Assessment of Cancer Therapy–General total score of 80.5 (STD 16.4). Quality of life scores did not differ by treatment arm, baseline diagnosis, pathological response, disease recurrence, or hysterectomy status. Self-efficacy for physical activity was more favorable among patients achieving pathological complete response at trial completion (p = 0.002). Perceived social support for health-related behaviors was limited, with no significant correlations between self-efficacy and social support. 74.4% of participants reported positive treatment experience and 85.4% would recommend levonorgestrel intrauterine device treatment. Conclusions Long-term quality of life and patient-reported outcomes following non-surgical management of early-stage endometrial adenocarcinoma and endometrial hyperplasia with atypia are favorable and comparable across conservative treatment strategies. These findings contribute to the understanding of long-term patient-reported outcomes following conservative management and underscore the importance of integrating survivorship-focused outcomes into shared treatment decision-making.