Evaluation of the Impact of Nurse-led Telephone on Treatment Compliance
Status
Conditions
Details and patient eligibility
About
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.
Full description
Purpose:
Study Design:
Enrollment
Sex
Ages
Volunteers
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.
Trial design
30 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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