Evaluation of the Impact of Nurse-led Telephone on Treatment Compliance

Study Overview
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Brief Summary
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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.

Detailed Description
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Purpose: Study Design:

Official Title
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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.

Conditions
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Carcinoma, Non-Small-Cell Lung

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female patient older than 18 years. Adult patient diagnosed with stage IIIb/IV NSCLC locally advanced or metastatic, with activating mutation(s) of EGFR and who is EGFR-TKI naïve. Patient for whom a decision of treatment with afatinib monotherapy has been taken in the frame of its marketing authorization. Out-patient. Patient having given written consent for participation in the study. Patient who is able to participate in the investigator's opinion. Patient affiliated with the French social security. Exclusion criteria: Patients participating in an interventional clinical study. Patients for whom a participation in an interventional clinical study is foreseen within 3 months following the study inclusion. Patients participating in a therapeutic education program.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group 1<br>Group without 'remote additional personalised nurse-led follow-up: patients will receive the healthcare given routinely by their medical team | |
| group 2<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up. | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score (0-6) Obtained With the Girerd Questionnaire | Girerd questionnaire is a questionnaire composed of 6 binary questions (yes/no) and is used to assess treatment compliance. The final score obtained is the number of questions to which the patient responded yes. Thus, the score ranges from 0 to 6. A patient will be classified as: Good compliant with score = 0. Minor non-compliant with score = 1 or 2. Non-compliant with score >2. | 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 | The cumulated dose (mg) of oral targeted therapy not taken between 2 visits is the sum of the doses (mg) of tablets not taken by the patient. The cumulated dose (mg) of oral targeted therapy not taken during the 3-month follow-up is the sum of the cumulated doses (mg) not taken between 2 visits during the 3-month follow-up. | 3 months | 
| Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Decision of the Medical Team. | Cumulated dose of oral targeted therapy not taken due to dose reduction following decision of the medical team. There were no participants with dose reduction hence the data is not available. | 3 months | 
| Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following the Medical Team Decision. | 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 (All Categories) Following Patient Decision. | Cumulated dose of oral targeted therapy not taken (all categories) following patient decision. Cumulated dose not taken in total is missing since no patient without therapy following patient decision | 3 months | 
| Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Patient Decision. | Cumulated dose of oral targeted therapy not taken due to dose reduction following patient decision. No participants with dose reduction. | 3 months | 
| Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following Patient Decision. | Cumulated dose of oral targeted therapy not taken due to temporary or definitive interruption following patient decision. No patient without therapy 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. | VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction. | 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 | The patients' quality of life was evaluated with the FACT-L questionnaire. This questionnaire explores 4 dimensions of well-being: physical, social and emotional. These items are completed by 9 questions specific to lung cancer. Subscale scores are added to obtain total score. Scores obtained with this questionnaire range between 0 and 136. The higher the score the better the quality of life. | Day0 (D0), Day30 (D30) and Day90 (D90) | 
| Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up. | Number of participants with emergency admissions (related to the treatment) during the 3-month follow-up are presented | Day30 (D30), Day60 (D60) and Day90 (D90) | 
| Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up | Number of participants with unplanned hospitalizations (related to the treatment) during the 3-month follow-up is presented | D30, D60, D90 | 
| Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up. | Duration of unplanned hospitalizations (related to the treatment) during the 3-month follow-up are presented | D30, D60 and D90 | 
| Number of Unplanned Visits to the Investigator During the 3-month Follow-up | Number of participants with unplanned visits to the investigator during the 3-month follow-up are presented | 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. | Number of participants with unplanned visits to a specialist, whatever is his specialty, other than the investigator during the 3-month follow-up is presented | D30, D60 and D90 | 
| Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up | Number of participants with unplanned visits to the general practitioner during the 3-month follow-up is presented | D30, D60 and D90 | 
| VAS Score (0-10) for Overall Investigator Satisfaction With the Level of Patient Care at D90 | VAS score (0-10) for overall investigator satisfaction with the level of patient care at D90 (Overall investigator satisfaction) is presented. VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction. | 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) | 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) (Overall general practitioner satisfaction) is presented. VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction. | 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). | 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)(Overall pharmacist satisfaction) is presented. VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction. | D90 | 
| Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up. | Number of calls made by the patients to their general practitioner during the 3-month follow-up is presented | D30, D60 and D90 | 
| Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up. | Number of calls made by the general practitioner to the patient during the 3-month follow-up is presented | D30, D60 and D90 | 
| Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up | Number of calls made by the patients to their medical team during the 3-month follow-up is presented | D30, D60 and D90 | 
| Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up | Number of calls made by the medical team to their patient during the 3-month follow-up is presented | D30, D60 and D90 | 
| Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up | Number of calls between the general practitioners and the medical teams during the 3-month follow-up is presented | 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. | Number of participants with Adverse events AEs, of AEs of grade ≥ 3, of serious adverse events (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 are presented | up to 3 months |