The ENSURE trial for women with low-risk, early-stage endometrial cancer: A randomized controlled trial comparing the effect of a reduced (4 visits/3 yr) versus usual (8-11 visits/3 yr) follow-up schedule on patient satisfaction, health care use, and disease perception.
Authors: van de Poll-Franse Lonneke , de Rooij Belle H , Creutzberg Carien L. , Kruitwagen Roy F.P.M. , Van Lonkhuijzen Luc , Apperloo Mirjam , Gerestein C G , Baalbergen Astrid , Boll Dorry , Vos M.Caroline , Ezendam Nicole PM 
Published: June 2022

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Background: Research suggests that most early-stage endometrial cancer patients do not need intensive follow-up to detect recurrences, improve survival, or discuss consequences of treatment. However, a minimal number of follow-up visits is needed to support necessary patient counselling and information provision. The aim of the ENSURE (ENdometrial cancer SURvivors’ follow-up carE) trial was to compare, for three years after diagnosis, satisfaction with care between women who received reduced follow-up (FU) care (4 visits) and women who received usual FU care according to the Netherlands guideline (8-11 visits). Methods: In this multicenter non-inferiority trial from the Netherlands, 316 women from 42 hospitals with FIGO stage IA/B low-risk endometrial cancer were randomized after treatment. Women allocated to reduced FU (n = 160) and usual FU (n = 156) completed questionnaires at baseline (after surgery), and after 6, 12 and 36 months. The primary outcome was satisfaction with FU care (Patient Satisfaction Questionnaire III total scale: PSQ-III). The predefined noninferiority margin was 6 points. Mixed linear regression and intention-to-treat analyses were used. Secondary outcomes were health care utilization, disease perception (Brief Illness Perception Questionnaire: BIPQ) and cancer recurrence. Results: 299 (95%) women completed the questionnaire at baseline; 291 (92%) at 6-months; 272 (86%) at 12 months and 222 (70%) at 36 months. Overall satisfaction with care was similar in the reduced FU (average 82; SD = 15) and usual FU (average 80; SD = 15) group. At 6, 12 and 36 months, more women (93%, 94% and 90%) in the reduced FU group were satisfied with their FU schedule than patients in usual FU group (79%, 79% and 82%; p < 0.001; p < 0.001; p = 0.050). During three years of FU care, women in the reduced FU group had an average of 3.8 (SD = 1.5) visits with their specialist/nurse compared to 6.8 (SD = 2.4) visits for women in the usual FU group. We observed a non-significant trend of less severe disease perception in patients in the reduced vs. the usual FU group: impact on life (M = 1.8; SD = 2.2 vs. M = 2.5; SD = 2.8); concern about disease (M = 1.5; SD = 2.1 vs. M = 2.3; SD = 2.9); emotional impact (M = 1.4; SD = 2.1 vs. M = 2.2; SD = 2.9). Nine women in the reduced FU group and five in the usual FU group developed a recurrence within three years after diagnosis (n.s.). Conclusions: Women with low-risk, early-stage endometrial cancer receiving reduced follow-up care were just as satisfied with their care as those women receiving follow-up care according to Netherlands guidelines. Compared with usual care, women in the reduced care group had fewer medical visits and, at the same time, more often reported being satisfied with this reduced frequency. Clinical trial information: NCT02413606.