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

Noreen Kearns, Laia Raigal-Aran, Kate O'Connell, Andrea Davis, Katie Bermingham, Seamus O'Reilly, Dearbhaile C Collins, Mark Corrigan, John Coulter, Vicki Cleary, Samantha Cushen, Aileen Flavin, Fiona Byrne, Aisling O'Grady, Deirdre O'Neill, Aileen Murphy, Darren Dahly, Brendan Palmer, Roisin M Connolly, Josephine Hegarty, Noreen Kearns, Laia Raigal-Aran, Kate O'Connell, Andrea Davis, Katie Bermingham, Seamus O'Reilly, Dearbhaile C Collins, Mark Corrigan, John Coulter, Vicki Cleary, Samantha Cushen, Aileen Flavin, Fiona Byrne, Aisling O'Grady, Deirdre O'Neill, Aileen Murphy, Darren Dahly, Brendan Palmer, Roisin M Connolly, Josephine Hegarty

Abstract

Background: The 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. This study assesses the feasibility of introducing a Women's Health Initiative cancer survivorship clinic in Ireland.

Methods: The trial https://spcare.bmj.com/content/9/2/209.short comprises an intervention and control arm. Two hundred participants will be recruited. Key eligibility (1) women with early-stage hormone receptor-positive breast or gynecologic 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 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 input from a dietitian 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. The 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.

Discussion: This protocol describes the implementation of a parallel arm randomized controlled trial (RCT) which examines the feasibility of delivering a Cancer Survivorship Clinic. The ePRO is an innovative symptom monitoring system which detects the treatment-related effects and provides individualized support for cancer survivors. The findings will provide direction for the implementation of future survivorship care.

Trial registration: ClinicalTrials.gov , NCT05035173 . Retrospectively registered on September 5, 2021.

Keywords: Cancer survivorship; Dietitian resource; Electronic patient-reported outcomes (ePROs); Nurse-led; Supportive care; Symptom management pathways.

Conflict of interest statement

RMC received a global education grant from Pfizer, and research funding from Merck Sharp and Dohme (MSD) Ireland, Pfizer, Daichii Sankyo, and Astra Zeneca to her institution. JH received a research grant from Pfizer. The other authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Women’s Health Initiative cancer survivorship clinic RCT Trial CONSORT flow diagram

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