Clinical trial · Interventional
Patient-Initiated Follow-Up for Women After Early Breast Cancer Treatment (LYSA2PIFU)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Survivorship | — | UNRESOLVED | — |
| Cancer Survivorship | — | UNRESOLVED | — |
| Early Stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
| Endocrine Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient-Initiated Follow-Up and ePRO Symptom Management | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LYSA2PIFU Intervention
- description
- 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.
- interventionNames
- Behavioral: Patient-Initiated Follow-Up and ePRO Symptom Management
Primary outcomes (3)
- measure
- Feasibility of Patient-Initiated Follow-Up - recruitment rate
- timeFrame
- 12 months
- description
- Measured by the recruitment rate of patients to the study.
- measure
- Feasibility of Patient-Initiated Follow up - retention rate
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available