NCT07840534

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
20mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Jun 2028

First Submitted

Initial submission to the registry

September 15, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

September 15, 2026

Last Update Submit

September 22, 2026

Conditions

Breast CancerBreast Cancer SurvivorshipCancer SurvivorshipEndocrine TherapyEarly Stage Breast Cancer

Keywords

Breast Cancer SurvivorshipPatient-Initiated Follow-UpElectronic Patient Reported OutcomesePROEndocrine TherapySymptom ManagementSupportive CareQuality of LifeSurvivorship CareDigital Health

Outcome Measures

Primary Outcomes (3)

  • Feasibility of Patient-Initiated Follow-Up - recruitment rate

    Measured by the recruitment rate of patients to the study.

    12 months

  • Feasibility of Patient-Initiated Follow up - retention rate

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

    12 months

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

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

    12 months

Secondary Outcomes (8)

  • Symptom Burden

    Baseline and 12 months

  • Health-Related Quality of Life

    Baseline and 12 months

  • Breast Cancer-Specific Quality of Life

    Baseline and 12 months

  • Self Care Agency

    Baseline and 12 months

  • Healthcare Utilisation - outpatient visits

    12 months

  • +3 more secondary outcomes

Study Arms (1)

LYSA2PIFU Intervention

EXPERIMENTAL

Participants receive access to a nurse-led patient-initiated follow-up model incorporating symptom management through electronic patient-reported outcomes, automated symptom-support resources, and symptom-triggered nurse consultations.

Behavioral: Patient-Initiated Follow-Up and ePRO Symptom Management

Interventions

Patient-Initiated Follow-Up and ePRO Symptom ManagementBEHAVIORAL

A 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.

LYSA2PIFU Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cork University Hospital

Cork, Ireland

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Josephine Hegarty, PhD

    University College Cork

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Johnston, Postdoctoral researcher

CONTACT

00353214903000kjohnson@ucc.ie

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Participants receive a single nurse-led patient-initiated follow-up intervention supported by ePRO symptom monitoring and symptom-triggered management pathways over 12 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 25, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

September 25, 2026

Record last verified: 2026-09

Locations

IE(1)