Clinical trial NCT02483416: Evaluation of the Impact of Nurse-led Telephone on Treatment Compliance
Official title: 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.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NSCLC EGFR mutated

Brief summary: 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: Purpose:

Study Design:

Eligibility criteria: 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.

Primary outcomes:
measure: The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up.
timeFrame: 3 months
Secondary outcomes:
measure: Score (0-6) Obtained With the Girerd Questionnaire
timeFrame: at Day 30 (D30), Day 60 (D60) and Day 90 (D90)
measure: Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Decision of the Medical Team
timeFrame: 3 months
measure: Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Decision of the Medical Team.
timeFrame: 3 months
measure: Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following the Medical Team Decision.
timeFrame: 3 months
measure: Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Patient Decision.
timeFrame: 3 months
measure: Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Patient Decision.
timeFrame: 3 months
measure: Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following Patient Decision.
timeFrame: 3 months
measure: Visual Analogue Scale (VAS) Score (0-10) for Overall Patient Satisfaction With the Level of Care (Information, Advice) at D90.
timeFrame: 3 months
measure: 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
timeFrame: Day0 (D0), Day30 (D30) and Day90 (D90)
measure: Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up.
timeFrame: Day30 (D30), Day60 (D60) and Day90 (D90)
measure: Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up
timeFrame: D30, D60, D90
measure: Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up.
timeFrame: D30, D60 and D90
measure: Number of Unplanned Visits to the Investigator During the 3-month Follow-up
timeFrame: D30, D60 and D90
measure: Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up.
timeFrame: D30, D60 and D90
measure: Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up
timeFrame: D30, D60 and D90
measure: VAS Score (0-10) for Overall Investigator Satisfaction With the Level of Patient Care at D90
timeFrame: D90
measure: 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)
timeFrame: D90
measure: 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).
timeFrame: D90
measure: Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.
timeFrame: D30, D60 and D90
measure: Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up.
timeFrame: D30, D60 and D90
measure: Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up
timeFrame: D30, D60 and D90
measure: Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up
timeFrame: D30, D60 and D90
measure: Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up
timeFrame: D30, D60, D90
measure: 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.
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Agen
country: France
facility: CLI Dr Calabet, Oncolgie, Agen
city: Aix en Provence cedex 1
country: France
facility: HOP Centre Hospitalier Pays d'Aix, Pneumo, Aix en Provence
city: Aix en Provence
country: France
facility: CLI Polyclinique du Parc Rambot, Pneumo, Aix en Provence
city: Arras
country: France
facility: HOP Centre Marie Curie, Onco, Arras
city: Bordeaux
country: France
facility: CLI Bordeaux Nord Aquitaine
city: Bordeaux
country: France
facility: CLI Tivoli
city: Brive La Gaillarde cedex
country: France
facility: CH, Oncologie, Brive la Gaillarde,
city: Bron cedex
country: France
facility: HOP Louis Pradel
city: Béziers
country: France
facility: HOP Centre Hospitalier de Béziers, Pneumo, Béziers
city: Castelnau le lez
country: France
facility: CLI du Parc, Pneumo, Castelnau le Lez
city: Chalons Sur Saône
country: France
facility: Centre médical N de Pontoux, Oncologie, Chalon sur Saône
city: Chauny
country: France
facility: HOP de Chauny
city: Creteil cedex
country: France
facility: Centre Hospitalier Intercommunal, Oncolgie, Crétail
city: Draguignan
country: France
facility: HOP La Dracénie, Onco, Draguignan
city: La Roche Sur Yon cedex
country: France
facility: HOP CHD La Roche sur Yon - Montaigu - Luçon, Pneumo
city: Le Puy en Velay
country: France
facility: HOP CH Emile Roux Le Puy, Pneumo, Le puy en Velay
city: Libourne
country: France
facility: HOP Hôpital Robert Boulin, Pneumo, Libourne
city: Lyon cedex 07
country: France
facility: HOP Saint Joseph et Saint Luc, Pneumo, Lyon
city: Lyon
country: France
facility: Hopital Privé Jean Mermoz
city: Meaux cedex
country: France
facility: CHG, Oncologie, Meaux
city: Montpellier
country: France
facility: CLI Clémentville
city: Mulhouse
country: France
facility: HOP Centre Hospitalier de Mulhouse, Pneumo, Mulhouse
city: Nancy
country: France
facility: CTR d'Oncologie de Gentilly, Onco, Nancy
city: Narbonne cedex
country: France
facility: CLI Polyclinique le Languedoc, Narbonne
city: Narbonne
country: France
facility: CLI Polyclinique le Languedoc, Narbonne
city: Perpignan
country: France
facility: CLI Saint-Pierre, Oncologie, Perpignan
city: Pringy
country: France
facility: CHR d'Annecy, Oncologie, Annecy
city: Quimper
country: France
facility: HOP Cornouaille, Pneumo, Quimper
city: Reims
country: France
facility: CLI Les Bleuets, Pneumologie, Reims
city: Saint-Quentin cedex
country: France
facility: HOP Centre Hospitalier de Saint Quentin, Pneumo, St-Quentin
city: Thonon les Bains
country: France
facility: HOP Hôpitaux du Léman
city: Toulon
country: France
facility: HOP HIA Saint-Anne
city: Toulouse
country: France
facility: CLI Pasteur
city: Toulouse
country: France
facility: CLI Pasteur
city: Valence
country: France
facility: Centre de Radiothérapie Marie Curie
city: Villefranche sur Saône Cedex
country: France
facility: HOP Nord Ouest de Villefranche, oncologie, Gleize
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: