Women treated for early-stage breast cancer commonly experience ongoing treatment-related symptoms while receiving adjuvant endocrine therapy. The LYSA2PIFU Trial will evaluate the feasibility and acceptability of a nurse-led Patient-Initiated Follow-Up (PIFU) model supported by electronic Patient-Reported Outcomes (ePROs), automated symptom-management resources, educational materials and symptom-triggered nurse consultations.
Female aged ≥18 years
Able to read and understand English
Access to the internet
Stage I-III hormone receptor-positive breast cancer
Not treated with curative intent
Premalignant disease only (DCIS or LCIS)
Unable to cooperate adequately with study procedures in the opinion of the investigator or supervising clinician
Single group
Patient-Initiated Follow-Up and ePRO Symptom Management
BehavioralA 12-month survivorship intervention combining electronic symptom monitoring, automated symptom-management resources, educational materials, symptom-specific pathways and nurse-led consultations triggered by participant-reported symptom burden.
Feasibility of Patient-Initiated Follow-Up - recruitment rate
Measured by the recruitment rate of patients to the study.
Feasibility of Patient-Initiated Follow up - retention rate
Retention rate is measured by the percentage of patients that complete the study.
Feasibility of Patient-Initiated Follow-Up - survey completion rates
Measured by the number of surveys completed by patients on the study
Symptom Burden
Changes in description of symptoms using symptom-report questionnaire (The questionnaire is a specifically designed 'Symptom Survey'. Score is from 5-50, where smaller scores indicate less symptom severity).
Health-Related Quality of Life
Change in cancer-related quality of life scores using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC QLQ-C30). The scale goes from 0-126, where higher scores indicate better quality of life.
Breast Cancer-Specific Quality of Life
Change in breast cancer-specific quality of life scores, measured by European Organisation for Research and Treatment of Cancer Quality of Life in Breast Cancer patients (QLQ-BR42). Scores between 0-168, where lower scores indicate better quality of life
Self Care Agency
Change in assessment of patient self-care agency and capability, measured using Appraisal of Self Care Agency Scale-Revised (ASAS-R) questionnaire. The scale is scored from 15-75, where higher scores indicate greater self care agency
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University College Cork
Lead sponsor
Cork University Hospital
Collaborator
Irish Cancer Society
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
