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

Pilot and Feasibility Studies

Study Protocol

Laia Raigal-Aran¹  Roisin M. Connolly²  Kate O’Connell²  Seamus O’Reilly³  Noreen Kearns⁴  Josephine Hegarty⁵  Mark Corrigan⁶  Aileen Murphy⁷  John Coulter⁸  Dearbhaile C. Collins⁹  Vicki Cleary^1,10  Deirdre O’Neill^1,11  Katie Bermingham^1,11  Andrea Davis^1,11  Fiona Byrne^1,12  Aisling O’Grady^1,12  Aileen Flavin^1,13  Brendan Palmer^1,14  Darren Dahly^1,14  Samantha Cushen^1,15 

[1] Cancer Research @UCC, College of Medicine and Health, University College Cork, Cork, Ireland;Cancer Research @UCC, College of Medicine and Health, University College Cork, Cork, Ireland;Department of Medical Oncology, Cork University Hospital, Cork, Ireland;Cancer Research @UCC, College of Medicine and Health, University College Cork, Cork, Ireland;Department of Medical Oncology, Cork University Hospital, Cork, Ireland;Department of Medical Oncology, South Infirmary Victoria University Hospital, Cork, Ireland;Catherine McAuley School of Nursing and Midwifery, University College Cork, Cork, Ireland;Catherine McAuley School of Nursing and Midwifery, University College Cork, Cork, Ireland;Cancer Research @UCC, College of Medicine and Health, University College Cork, Cork, Ireland;Department of Academic Surgery, Cork University Hospital, Cork, Ireland;Department of Economics, Cork University Business School, University College Cork, Cork, Ireland;Department of Gynaecology Oncology, Cork University Maternity Hospital, Cork, Ireland;Department of Medical Oncology, Cork University Hospital, Cork, Ireland;Department of Medical Oncology, Cork University Hospital, Cork, Ireland;Department of Gynaecology Oncology, Cork University Maternity Hospital, Cork, Ireland;Department of Medical Oncology, Cork University Hospital, Cork, Ireland;Department of Nutrition and Dietetics, Cork University Hospital, Cork, Ireland;Department of Nutrition and Dietetics, Cork University Hospital, Cork, Ireland;Department of Radiation Oncology, Cork University Hospital, Cork, Ireland;HRB Clinical Research Facility, University College Cork, Cork, Ireland;School of Public Health, University College Cork, Cork, Ireland;School of Food and Nutritional Sciences, University College Cork, Cork, Ireland;

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

DOI  :  10.1186/s40814-022-01186-x

 received in 2022-05-03, accepted in 2022-10-12,  发布年份 2022

来源: Springer

【 摘 要 】

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. This study assesses 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 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT05035173. Retrospectively registered on September 5, 2021

【 授权许可】

CC BY   
© The Author(s) 2022. corrected publication 2022

【 图 表 】

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