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P195 Effect of a reduced follow-up schedule on patient satisfaction with care among early-stage endometrial cancer patients: one-year preliminary results of the ENSURE randomized controlled trial
  1. NPM Ezendam1,2,
  2. BH de Rooij1,2,
  3. CL Creutzberg3,
  4. RFPM Kruitwagen4,
  5. LR van Lonkhuijzen5,
  6. MJA Apperloo6,
  7. K Gerestein7,
  8. A Baalbergen8,
  9. D Boll9,
  10. MC Vos10 and
  11. LV van de Poll-Franse1,11,12
  1. 1Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht
  2. 2Medical and Clinical Psychology, Tilburg University, Tilburg
  3. 3Leiden University Medical Center, Leiden
  4. 4Maastricht University Medical Center, Maastricht, The Netherlands
  5. 5Amsterdam UMC, Location AMC, Amsterdam, New Caledonia
  6. 6University Medical Center Groningen, Groningen
  7. 7Meander Medisch Centrum, Amersfoort
  8. 8Reinier de Graaf Hospital, Delft
  9. 9Catharina Hospital, Eindhoven
  10. 10Elisabeth-TweeSteden Hospital, Tilburg
  11. 11Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Amsterdam
  12. 12Tilburg University, Tilburg, The Netherlands


Introduction/Background It has been hypothesized that the frequency of follow-up visits for patients with early-stage endometrial cancer could be decreased. Therefore, the aim of the ENSURE trial was to assess patient satisfaction at 3-years follow-up among patients receiving a reduced follow-up schedule (4 visits/3 years) compared to patients receiving follow-up care according to Dutch guideline (10–13 visits/5 years). In the current analysis 1-year results were evaluated.

Methodology In this Dutch multicenter non-inferiority trial 320 patients diagnosed with stage 1A/B low-risk endometrial cancer, for whom adjuvant radiotherapy is not indicated, were randomized. Patients allocated to the reduced-follow-up group (n=162) and to the control group (n=158) were asked to complete questionnaires at baseline, after 6 and 12 months. Primary outcome was patient satisfaction with follow-up care as assessed with the Patient Satisfaction Questionnaire III (total scale) at 3-year follow-up. The predefined non-inferiority margin was 6 points (maximum acceptable difference), with a range of 0 to 100. Mixed linear regression and intention-to-treat analyses were used.

Results At 1-year follow-up, 272 participants had completed the questionnaire (85%). Preliminary results showed that the average satisfaction with care (total scale) score was 83 (SD=13) in the reduced follow-up arm and 82 (SD=13) in the control arm, where a higher score denotes a higher satisfaction (p=0.96). Also, technical competence of the health care provider and interpersonal aspects were scored equally in both groups, 81 (SD=15; p=0.52) and 87 (SD=14; p=0.95), respectively. Finally, access to care was evaluated similarly by patients in the reduced follow-up arm (M=81; SD=15) and the control arm (M=78; SD=15), p=0.39.

Conclusion These findings indicate no difference in satisfaction with care after 1-year follow-up among early stage endometrial cancer patients who receive a reduced follow-up schedule compared to patients receiving follow-up according to the Dutch guidelines. For final conclusions 3-year results of this trial need to be awaited.

Disclosure The study was funded by the Dutch Cancer Society (IKZ 2014-6677). The authors report no disclosures. Trial registration: NCT02413606.

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