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NCT Number: NCT07840534

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

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.

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Key information

Conditions

Breast Cancer Breast Cancer Survivorship Breast Diseases Breast Neoplasms Cancer Survivorship Early Stage Breast Cancer Endocrine Therapy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cork University Hospital

Cork, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-Initiated Follow-Up and ePRO Symptom Management

Behavioral

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.

Primary outcomes

  1. Feasibility of Patient-Initiated Follow-Up - recruitment rate

    Time frame: 12 months

    Measured by the recruitment rate of patients to the study.

  2. Feasibility of Patient-Initiated Follow up - retention rate

    Time frame: 12 months

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

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

    Time frame: 12 months

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

Secondary outcomes

  1. Symptom Burden

    Time frame: Baseline and 12 months

    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).

  2. Health-Related Quality of Life

    Time frame: Baseline and 12 months

    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.

  3. Breast Cancer-Specific Quality of Life

    Time frame: Baseline and 12 months

    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

  4. Self Care Agency

    Time frame: Baseline and 12 months

    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

  5. Healthcare Utilisation - outpatient visits

    Time frame: 12 months

    Measurement of the number of patient outpatient visits during the study

  6. Healthcare Utilisation - inpatient admissions

    Time frame: 12 months

    Measurement of number of inpatient admissions during the study

  7. Healthcare Utilisation - emergency department attendances

    Time frame: 12 months

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

  8. Participant Satisfaction and Usability

    Time frame: 12 months

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University College Cork

Other

Collaborators

  • Cork University Hospital
  • Irish Cancer Society

Registry information

Official study 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

Acronym: LYSA2PIFU

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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