Breast CancerLYSA2PIFUNCT07840534
Patient-Initiated Follow-Up for Women After Early Breast Cancer Treatment (LYSA2PIFU)
A study testing Patient-Initiated Follow-Up and ePRO Symptom Management in people with Breast Cancer and Breast Cancer Survivorship, run by University College Cork at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Survivorship, Cancer Survivorship
- What is being tested?
- Patient-Initiated Follow-Up and ePRO Symptom Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 1 Oct 2026to 1 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The LYSA (Linking You to Support and Advice) 2 Trial: A Nurse-Led Patient-Initiated Follow-Up (PIFU) Model for Women Who Have Finished Treatment for Breast Cancer
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Breast Cancer Survivorship, Cancer Survivorship, Endocrine Therapy, Early Stage Breast Cancer
- Being tested
- Patient-Initiated Follow-Up and ePRO Symptom Management
- Keywords
- Breast Cancer Survivorship, Patient-Initiated Follow-Up, Electronic Patient Reported Outcomes, ePRO, Endocrine Therapy, Symptom Management, Supportive Care, Quality of Life, Survivorship Care, Digital Health
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Initiated Follow-Up and ePRO Symptom ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Patient-Initiated Follow-Up and ePRO Symptom Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Patient-Initiated Follow-Up - recruitment rate
Measured by the recruitment rate of patients to the study.
Measured: 12 months
Feasibility of Patient-Initiated Follow up - retention rate
Retention rate is measured by the percentage of patients that complete the study.
Measured: 12 months
Feasibility of Patient-Initiated Follow-Up - survey completion rates
Measured by the number of surveys completed by patients on the study
Measured: 12 months
Secondary outcomes (8)
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).
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline and 12 months
Healthcare Utilisation - outpatient visits
Measurement of the number of patient outpatient visits during the study
Measured: 12 months
Healthcare Utilisation - inpatient admissions
Measurement of number of inpatient admissions during the study
Measured: 12 months
Healthcare Utilisation - emergency department attendances
Measurement of the number of emergency department attendances during the study.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants receive a single nurse-led patient-initiated follow-up intervention supported by ePRO symptom monitoring and symptom-triggered management pathways over 12 months.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Cork University Hospital, Irish Cancer Society
- Responsible party
- Sponsor
- Investigators
- Josephine Hegarty, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840534
- Sponsor's protocol ID
- 26009
- Other IDs
- LYSA25COHE
- Acronym
- LYSA2PIFU
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing will be considered following study completion and publication of primary findings, in accordance with ethical approval, GDPR requirements and institutional policies.