Evaluation of the Impact of a Nurse-led Telephone Follow-up on Treatment Compliance of Patients Treated From a Locally Advanced or Metastatic Non-small-cell Lung Cancer (NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) Mutation(s).The PARTAGE Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 34
- 主要终点
- The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up.
研究概览
简要总结
The study will take place over a period of 27 months. The recruitment phase will last approximately 24 months and each patient will participate for approximately 3 months.
At the inclusion visit (D0), the investigator will ask the patient whether he would like to participate in the study and will obtain his written consent.
Patients agreeing to participate will be randomised (3:1 ratio) and included in one of the following 2 groups:
Group without 'remote additional personalised nurse-led follow-up: patients will receive the healthcare given routinely by their medical team (100 patients).
Group with 'remote additional personalised nurse-led follow-up: patients will receive telephone calls from a nurse in addition to the healthcare given routinely by their medical team (300 patients).
All the patients will be seen according to normal practice by the study medical team.
Patients in the group with 'remote additional personalised nurse-led follow-up will be contacted 8 times during the study (at D1, D7, D14, D21, D28, D44, D59 and D89). The nurse will make sure that the treatment takes place in good conditions; she cannot intervene in the medical care of the patient, nor give answer to the questions relative to the disease or to the treatment of the patient. The medical team remains the privileged contact of the patient.
详细描述
Purpose:
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up.
时间窗: 3 months
The cumulated dose (mg) of oral targeted therapy taken between visits is the sum of the doses (mg) of the tablets taken by the patient. The cumulated dose (mg) of the oral targeted therapy taken during the 3-month follow-up is the sum of the doses (mg) cumulated taken between visits during the 3-month follow-up.
次要结局
- Score (0-6) Obtained With the Girerd Questionnaire(at Day 30 (D30), Day 60 (D60) and Day 90 (D90))
- Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Decision of the Medical Team(3 months)
- Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following the Medical Team Decision.(3 months)
- Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Decision of the Medical Team.(3 months)
- Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following Patient Decision.(3 months)
- Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up.(D30, D60 and D90)
- Number of Unplanned Visits to the Investigator During the 3-month Follow-up(D30, D60 and D90)
- Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Patient Decision.(3 months)
- Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Patient Decision.(3 months)
- Visual Analogue Scale (VAS) Score (0-10) for Overall Patient Satisfaction With the Level of Care (Information, Advice) at D90.(3 months)
- Change in Quality of Life Questionnaire Functional Assessment of Cancer Therapy Lung (FACT-L) Score Between D30 and D0, Between D90 and D30 and Between D90 and D0(Day0 (D0), Day30 (D30) and Day90 (D90))
- Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up.(Day30 (D30), Day60 (D60) and Day90 (D90))
- Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up(D30, D60, D90)
- Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up(D30, D60 and D90)
- VAS Score (0-10) for Overall General Practitioner Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up)(D90)
- Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up.(D30, D60 and D90)
- Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up(D30, D60 and D90)
- Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up.(D30, D60 and D90)
- Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up(D30, D60 and D90)
- VAS Score (0-10) for Overall Investigator Satisfaction With the Level of Patient Care at D90(D90)
- VAS Score (0-10) for Overall Pharmacist Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up).(D90)
- Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.(D30, D60 and D90)
- Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up(D30, D60, D90)
- Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction.(up to 3 months)