Patient-Initiated Follow-Up for Women After Early Breast Cancer Treatment (LYSA2PIFU)

N/ANot Yet RecruitingNCT07840534

University College Cork30 enrolled

Overview

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.

Single-arm complex interventional feasibility study evaluating a nurse-led ePRO-supported Patient-Initiated Follow-Up survivorship model for women with Stage I-III hormone receptor-positive HER2-negative breast cancer receiving adjuvant endocrine therapy. Participants receive continuous access to symptom monitoring, educational resources, automated symptom responses and nurse-led consultations over 12 months. Outcomes include feasibility, symptom burden, quality of life, self-care agency, healthcare utilisation and participant satisfaction.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer Breast Cancer Survivorship Cancer Survivorship

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female aged ≥18 years * Able to read and understand English * Access to the internet * Stage I-III hormone receptor-positive breast cancer * HER2-negative disease * Within 12 months of completion of primary curative treatment * Receiving or recommended to commence adjuvant endocrine therapy * Able and willing to provide informed consent Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Feasibility of Patient-Initiated Follow-Up - recruitment rate

Measured by the recruitment rate of patients to the study.

Time frame: 12 months

Feasibility of Patient-Initiated Follow up - retention rate

Retention rate is measured by the percentage of patients that complete the study.

Time frame: 12 months

Feasibility of Patient-Initiated Follow-Up - survey completion rates

Measured by the number of surveys completed by patients on the study

Time frame: 12 months

Secondary Outcomes

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).

Time frame: Baseline and 12 months

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.

Time frame: Baseline and 12 months

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

Time frame: Baseline and 12 months

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

Time frame: Baseline and 12 months

Healthcare Utilisation - outpatient visits

Measurement of the number of patient outpatient visits during the study

Time frame: 12 months

Healthcare Utilisation - inpatient admissions

Measurement of number of inpatient admissions during the study

Time frame: 12 months

Healthcare Utilisation - emergency department attendances

Measurement of the number of emergency department attendances during the study.

Time frame: 12 months

Participant Satisfaction and Usability

Questionnaire on acceptability and usability of the intervention and platform. This is a custom designed survey, rated on a scale of 0-85 where higher scores indicate a higher satisfaction.

Time frame: 12 months

Patient-Initiated Follow-Up for Women After Early Breast Cancer Treatment (LYSA2PIFU)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts