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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of Patient-Initiated Follow-Up - recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
LYSA2PIFU Intervention
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.
干预措施: Patient-Initiated Follow-Up and ePRO Symptom Management (Behavioral)
结局指标
主要结局
Feasibility of Patient-Initiated Follow-Up - recruitment rate
时间窗: 12 months
Measured by the recruitment rate of patients to the study.
Feasibility of Patient-Initiated Follow up - retention rate
时间窗: 12 months
Retention rate is measured by the percentage of patients that complete the study.
Feasibility of Patient-Initiated Follow-Up - survey completion rates
时间窗: 12 months
Measured by the number of surveys completed by patients on the study
次要结局
- 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)
- Healthcare Utilisation - inpatient admissions(12 months)
- Healthcare Utilisation - emergency department attendances(12 months)
- Participant Satisfaction and Usability(12 months)