An interventional study of Patient-Initiated Follow-Up and ePRO Symptom Management in Breast Cancer, Breast Cancer Survivorship and Cancer Survivorship, sponsored by University College Cork. Not yet recruiting at 1 site in Ireland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by University College Cork · Not applicable, Interventional, and Supportive care
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 30 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University College Cork is the lead sponsor of 119 studies on the registry; 25 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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