TY - JOUR
T1 - Effect of reduced follow-up care on patient satisfaction with care among patients with endometrial cancer
T2 - The ENSURE randomized controlled trial
AU - Ezendam, Nicole P.M.
AU - de Rooij, Belle H.
AU - Creutzberg, Carien L.
AU - Kruitwagen, Roy F.P.M.
AU - van Lonkhuijzen, Luc R.P.M.
AU - Apperloo, Mirjam J.A.
AU - Gerestein, Kees
AU - Baalbergen, Astrid
AU - Boll, Dorry
AU - Vos, M. Caroline
AU - van de Poll-Franse, Lonneke V.
AU - ENSURE Study Group
N1 - Funding Information:
This trial was funded by the Dutch Cancer Society \u2013 IKZ2014-6677.This trial was funded by the Dutch Cancer Society \u2013 IKZ2014-6677. The funding Organization had no role in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication. We gratefully acknowledge all including centers, all patients participating in the study, and the trial bureau of the Netherlands Comprehensive Cancer Organization, specifically Karin Groothuis and Hilde Dijcker-van der Linden, for their contributions to this trial.
Funding Information:
This trial was funded by the Dutch Cancer Society \u2013 IKZ2014-6677 .
Funding Information:
This trial was funded by the Dutch Cancer Society \u2013 IKZ2014-6677 . The funding Organization had no role in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication. We gratefully acknowledge all including centers, all patients participating in the study, and the trial bureau of the Netherlands Comprehensive Cancer Organization, specifically Karin Groothuis and Hilde Dijcker-van der Linden, for their contributions to this trial.
Publisher Copyright:
© 2024 The Authors
PY - 2024/9/1
Y1 - 2024/9/1
N2 - Background: Evidence on the optimal follow-up schedule after endometrial cancer is lacking. The study aim was to compare satisfaction with care between women who received reduced follow-up care and women who received usual guideline-directed follow-up care for three years after surgery. Methods: The ENSURE (ENdometrial cancer SURvivors' follow-up carE) trial was a non-inferiority randomized controlled multicenter trial in 42 hospitals in the Netherlands. The intervention arm received reduced follow-up care (4 visits/3 years), while the control group received usual follow-up care (8–11 visits/3 years). Primary outcome was overall satisfaction with care, PSQIII score, over three years follow-up, with a non-inferiority margin of 6. Mixed linear regression, intention-to-treat and per-protocol analyses (presented below) were used. Results: Among 316 women included, overall satisfaction with care was not lower in the reduced follow-up (mean 82; SD = 15) compared with the usual follow-up group (mean 80; SD = 15) group (B = 1.80(-2.09;5.68)). At 6, 12 and 36 months, more women (93/94/90%) in the reduced follow-up group were satisfied with their follow-up schedule than in the usual follow-up group (79/79/82%; p < 0.001; p < 0.001; p = 0.050). Conclusions and relevance: Women with low-risk, early-stage endometrial cancer who received reduced follow-up care were no less satisfied with their care than women receiving usual follow-up care. Compared with usual follow-up, women in the reduced follow-up group had fewer clinical visits and, at the same time, more often reported being satisfied with their follow-up schedule. Findings suggest that reduced follow-up care may be the new standard, but should be tailored to meet additional needs where indicated.
AB - Background: Evidence on the optimal follow-up schedule after endometrial cancer is lacking. The study aim was to compare satisfaction with care between women who received reduced follow-up care and women who received usual guideline-directed follow-up care for three years after surgery. Methods: The ENSURE (ENdometrial cancer SURvivors' follow-up carE) trial was a non-inferiority randomized controlled multicenter trial in 42 hospitals in the Netherlands. The intervention arm received reduced follow-up care (4 visits/3 years), while the control group received usual follow-up care (8–11 visits/3 years). Primary outcome was overall satisfaction with care, PSQIII score, over three years follow-up, with a non-inferiority margin of 6. Mixed linear regression, intention-to-treat and per-protocol analyses (presented below) were used. Results: Among 316 women included, overall satisfaction with care was not lower in the reduced follow-up (mean 82; SD = 15) compared with the usual follow-up group (mean 80; SD = 15) group (B = 1.80(-2.09;5.68)). At 6, 12 and 36 months, more women (93/94/90%) in the reduced follow-up group were satisfied with their follow-up schedule than in the usual follow-up group (79/79/82%; p < 0.001; p < 0.001; p = 0.050). Conclusions and relevance: Women with low-risk, early-stage endometrial cancer who received reduced follow-up care were no less satisfied with their care than women receiving usual follow-up care. Compared with usual follow-up, women in the reduced follow-up group had fewer clinical visits and, at the same time, more often reported being satisfied with their follow-up schedule. Findings suggest that reduced follow-up care may be the new standard, but should be tailored to meet additional needs where indicated.
KW - Endometrial cancer
KW - Follow-up
KW - Health care use
KW - Patient satisfaction
KW - RCT
KW - Worry
U2 - 10.1016/j.ygyno.2024.06.020
DO - 10.1016/j.ygyno.2024.06.020
M3 - Article
SN - 0090-8258
VL - 188
SP - 169
EP - 183
JO - Gynecologic Oncology
JF - Gynecologic Oncology
ER -