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2022-RA-683-ESGO The ENSURE trial for women with early-stage endometrial cancer: A randomized controlled trial comparing the effect of a reduced versus usual follow-up schedule on patient satisfaction, health care use, and disease perceptions
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  1. Nicole PM Ezendam1,2,
  2. Belle H de Rooij1,2,
  3. Carien L Creutzberg3,
  4. Roy F Kruitwagen4,
  5. Luc RCW van Lonkhuijzen5,
  6. Mirjam JA Apperloo6,
  7. Kees Gerestein7,
  8. Astrid Baalbergen8,
  9. Dorry Boll9,
  10. M Caroline Vos10 and
  11. Lonneke V van de Poll-Franse1,2,11
  1. 1Netherlands Comprehensive Cancer Organisation, Utrecht, Netherlands
  2. 2Tilburg University, Tilburg, Netherlands
  3. 3Leiden University Medical Center, Leiden, Netherlands
  4. 4Maastricht University Medical Center, Maastricht, Netherlands
  5. 5Amsterdam University Medical Centers, location AMC, Amsterdam, Netherlands
  6. 6Medical Centre Leeuwarden, Leeuwarden, Netherlands
  7. 7Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
  8. 8Reinier de Graaf Hospital, Delft, Netherlands
  9. 9Catharina hospital, Eindhoven, Netherlands
  10. 10Elisabeth-TweeSteden Hospital, Tilburg, Netherlands
  11. 11Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands

Abstract

Introduction/Background Research suggests that most early-stage endometrial cancer patients do not need intensive follow-up. The aim of the ENSURE (Endometrial cancer SURvivors’ follow-up care) trial was to compare satisfaction with care between women who received a reduced follow-up (FU) schedule (4 visits) and women who received the usual FU schedule according to the Dutch guideline (8–11 visits) for three years after treatment.

Methodology In this multicentre non-inferiority trial, 316 women from 42 hospitals with FIGO stage IA/B endometrial cancer were randomly allocated to reduced FU (n=160) or usual FU care (n=156). The women completed questionnaires at baseline (after surgery), and after 6, 12 and 36 months. The primary outcome was satisfaction with care (PSQ-III) with a predefined noninferiority margin of 6 points (range 0–100). Mixed linear regressions were used.

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. During three years after treatment, women in the reduced FU group had a median of 3.5 [IQR 3.0–5.0] visits with their specialist/nurse compared to 7.0 [IQR 6.0–9.0] visits for women in the usual FU group. Overall satisfaction with care was similar in the reduced FU (M=82;SD=15) and usual FU (M=82;SD=13) group. At 6, 12 and 36 months, more patients (93/94/90%) in the reduced FU arm were satisfied with their FU schedule than patients in usual FU arm (79/78/82%). Nine women in the reduced FU group and five in the usual FU group developed a recurrence (n.s.).

Conclusion Women receiving reduced follow-up care were just as satisfied with their care as those receiving follow-up care according to Dutch guidelines. Compared to 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.

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