Evaluation of a complex survivorship intervention incorporating electronic patient-reported outcomes in early stage breast and gynecologic cancer: Results from the Linking You to Support and Advice (LYSA) randomized controlled trial.
Authors: O'Connell Kate , Raigal Laia Aran , Johnston Katie E , Cushen Samantha , Flynn Naoimh Marie , O'Reilly Seamus , Collins Dearbhaile Catherine , Noonan Sinead , Cleary Vicki , Kearns Noreen , Medved Katarina , Davis Andrea , Byrne Fiona , Dahly Darren L , Palmer Brendan Anthony , Murphy Aileen , McInerney Veronica Bridget , Lowery Aoife J , Hegarty Josephine , Connolly Roisin M. 
Published: June 2024

1505

Background: Expert consensus supports a multidisciplinary strategy in cancer survivorship care to enhance patient outcomes and quality of life. We hypothesized that introducing a women’s survivorship clinic into routine follow up care would be feasible, and associated with improved symptom management and quality of life (QOL). Methods: LYSA was a multisite randomized controlled trial with parallel arms (experimental and active comparator), co-designed with public and patient involvement. Eligibility: early-stage hormone receptor-positive breast or gynaecologic cancer (GYN) within 12 months of completing primary therapy, and internet access (NCT05035173). Experimental arm attended a nurse-led clinic targeting symptom management, and dietetic consultation. Electronic patient-reported outcome (ePRO) assessments were undertaken at baseline, and bimonthly to 12 months. An online trigger alert system facilitated symptom management. Active comparator arm attended the nurse-led clinic at baseline and end of study. Primary endpoint (feasibility): Proportions of participants completing baseline and follow up ePRO surveys, and engaging in healthcare consultations after ePRO triggers. Pilot efficacy endpoints: changes in cancer-related symptom (PROMIS, PRO-CTCAE, Fear of Cancer Recurrence), health-related QOL Questionnaires (EORTC-QLQ, EQ5D5L) . Sample size target (n=200) facilitated feasibility outcomes. Between arm differences were estimated using generalized linear model, adjusted for baseline outcome. Results: 200 women were randomized, March 2021-August 2022 across two sites; 84% breast and 16% GYN. Consent was obtained in clinic (51%), video call (33%) or phone (16%). Median age was 54 (range 23-78). Of the 173 participants completing the study (n = 90 experimental, 83 comparator), all completed both baseline and end of study surveys. Following symptom triggers (experimental arm), there were 322 study nurse visits across 86 participants, and 243 dietician visits across 73 participants. Engagement with healthcare and other supportive resources was approximately twice more than comparator arm, due to referral. There were no notable between-arm differences with respect to EQ5D5L items at study end. However, experimental arm participants had better EORTC Total scores at study end relative to comparator (difference in means -3.87 95%CI -6.58 to -1.16, p=0.005). There were also significant (p < 0.05) differences observed between the arms for 8/12 symptom items reflecting less fatigue, anxiety and depression in experimental arm at study end. Conclusions: The LYSA trial met its primary feasibility endpoint, with high rates of ePRO completion. Secondary endpoint analysis is ongoing including an economic analysis and future studies. Clinical trial information: NCT05035173 .