The Women’s Health Initiative cancer survivorship clinic incorporating electronic patient reported outcomes: a study protocol for the Linking You to Support and Advice (LYSA) randomized controlled trial.

Abstract

BackgroundThe improved survival rate for many cancers in high income countries demands a coordinated multidisciplinary approach to survivorship care and service provision to ensure optimal patient outcomes and quality of life. The primary aim of this randomized controlled trial (RCT) is to assess the feasibility of introducing a Women’s Health Initiative Cancer Survivorship Clinic in Ireland. MethodsThe trial comprises an intervention and control arm. Two hundred participants will be recruited. Key eligibility 1) women with early-stage hormone receptor-positive breast or gynaecologic cancer (cervix or endometrial), within 12 months of completion of primary curative therapy, and 2) access to the internet. The complex intervention comprises a nurse-led pilot clinic targeting symptom management through a trigger alert system, utilizing electronic patient reported outcome (ePRO) assessments at baseline, and 2, 4, 6, 8, 10, and 12 months. It also includes dietitian-led component monitoring diet and nutritional status. The control group will receive their usual care pathway standard of care and attend the cancer survivorship clinic and complete ePRO assessments at the start and end of the study. Primary endpoint (feasibility) includes: the proportion of enrolled participants who complete baseline and follow-up ePRO surveys, and partake in health professional consultations after ePRO data triggers. Secondary endpoints include: changes in cancer-related symptom scores assessed by ePROs, health related-Quality of Life Questionnaire (QLQ) scores, Appraisal Self-Care Agency-R scores, and adjuvant endocrine therapy medication adherence. A process evaluation will capture the experiences of participation in the study, and the healthcare costs will be examined as part of the economic analysis.Ethical approval was granted in December 2020, with accrual commencing in March 2021.DiscussionThis protocol describes the implementation of a parallel arm RCT which examines the feasibility of delivering a Cancer Survivorship Clinic. The ePRO is an innovative symptom monitoring system which detects treatment related affects and provides individualized support for cancer survivors. The findings will provide direction for the implementation of future survivorship care. Trial Registration ClinicalTrials.gov, NCT05035173. Registered September 5th 2021 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT05035173?cntry=IE&city=Cork&draw=1&rank=10