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.

• DOI: 10.1200/jco.2024.42.16_suppl.1505
• Publication Date: 2024-06-04T18:44:16Z
• Authors: Kate O'Connell; Laia Aran Raigal; Katie E Johnston; Samantha Cushen; Naoimh Marie Flynn; Seamus O'Reilly; Dearbhaile Cather...; Sinead Noonan; Vicki Cleary; Noreen Kearns; Katarina Medved; Andrea Davis; Fiona Byrne; Darren L Dahly; Brendan Anthony P...; Aileen Murphy; Veronica Bridget ...; Aoife J Lowery; Josephine Hegarty; Roisin M. Connolly
• Keywords: Gynecologic cancer

1505 Background: Expert consensus supports a multidisciplinary strategy in cancer survivorship care to enhance patient outcomes and quality of life. We hypothesized that introducing women’s clinic into routine follow up would be feasible, associated with improved symptom management life (QOL). Methods: LYSA was multisite randomized controlled trial parallel arms (experimental active comparator), co-designed public involvement. Eligibility: early-stage hormone receptor-positive breast or gynaecologic (GYN) within 12 months completing primary therapy, internet access (NCT05035173). Experimental arm attended nurse-led targeting management, dietetic consultation. Electronic patient-reported outcome (ePRO) assessments were undertaken at baseline, bimonthly months. An online trigger alert system facilitated management. Active comparator the baseline end study. Primary endpoint (feasibility): Proportions participants ePRO surveys, engaging healthcare consultations after triggers. Pilot efficacy endpoints: changes cancer-related (PROMIS, PRO-CTCAE, Fear Cancer Recurrence), health-related QOL Questionnaires (EORTC-QLQ, EQ5D5L) . Sample size target (n=200) feasibility outcomes. Between differences estimated using generalized linear model, adjusted for outcome. Results: 200 women randomized, March 2021-August 2022 across two sites; 84% 16% GYN. Consent obtained (51%), video call (33%) phone (16%). Median age 54 (range 23-78). Of 173 study (n = 90 experimental, 83 all completed both surveys. Following triggers arm), there 322 nurse visits 86 participants, 243 dietician 73 participants. Engagement other supportive resources approximately twice more than arm, due referral. There no notable between-arm respect EQ5D5L items end. However, experimental had better EORTC Total scores relative (difference means -3.87 95%CI -6.58 -1.16, p=0.005). also significant (p < 0.05) observed between 8/12 reflecting less fatigue, anxiety depression Conclusions: The met its endpoint, high rates completion. Secondary analysis is ongoing including an economic future studies. Clinical information: NCT05035173