Patient-initiated follow-up in women with early-stage endometrial cancer: A long-term follow-up of the OPAL trial

Abstract

Objective: A long-term follow-up of the OPAL trial to compare the effect of patient-initiated (PIFU) versus hospital-based (HBFU) follow-up on fear of cancer recurrence (FCR), quality of life (QoL) and healthcare use after 34 months of follow-up.

Design: Pragmatic, multicentre randomised trial.

Setting: Four Danish departments of gynaecology between May 2013 and May 2016.

Population: 212 women diagnosed with stage I low-intermediate risk endometrial carcinoma.

Methods: The control group attended HBFU with regular outpatient visits (i.e., 8) for 3 years after primary treatment. The intervention group underwent PIFU with no prescheduled visits but with instructions about alarm symptoms and options of self-referral.

Main outcome measures: The endpoints were FCR as measured by the Fear of Cancer Recurrence Inventory (FCRI) and QoL as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire C-30 (EORTC QLQ C-30), and healthcare use as measured by questionnaires and chart reviews after 34 months of follow-up.

Results: FCR decreased from baseline to 34 months in both groups and no difference was found between allocations (difference -6.31 [95% confidence interval -14.24 to 1.63]). QoL remained stable with no difference in any domains between the two arms at 34 months using a linear mixed model analysis. The use of healthcare was significantly lower in the PIFU group (P < 0.01).

Conclusion: Patient-initiated follow-up is a valid alternative to hospital-based follow-up for people who have been treated for endometrial cancer and have low risk of recurrence.

Keywords: fear of cancer; gynaecological malignancy; patient-initiated follow-up; post-treatment surveillance; recurrence; recurrence, endometrial carcinoma.