Study Stopped
Poor recruitment
Evaluation of the Impact of Nurse-led Telephone on Treatment Compliance
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.
1 other identifier
observational
30
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2015
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2015
CompletedFirst Posted
Study publicly available on registry
June 26, 2015
CompletedStudy Start
First participant enrolled
November 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2017
CompletedResults Posted
Study results publicly available
March 1, 2019
CompletedMarch 1, 2019
October 1, 2018
1.3 years
April 9, 2015
February 26, 2018
October 31, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (24)
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 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 the Medical Team Decision.
3 months
Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Patient Decision.
3 months
- +19 more secondary outcomes
Study Arms (2)
group 1
Group without 'remote additional personalised nurse-led follow-up: patients will receive the healthcare given routinely by their medical team
group 2
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
Eligibility Criteria
NSCLC EGFR mutated
You may qualify if:
- 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.
You may not qualify if:
- Patients participating in a therapeutic education program.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
CLI Dr Calabet, Oncolgie, Agen
Agen, 47000, France
HOP Centre Hospitalier Pays d'Aix, Pneumo, Aix en Provence
Aix-en-Provence, 13616, France
CLI Polyclinique du Parc Rambot, Pneumo, Aix en Provence
Aix-en-Provence, 13617, France
HOP Centre Marie Curie, Onco, Arras
Arras, 62000, France
HOP Centre Hospitalier de Béziers, Pneumo, Béziers
Béziers, 34500, France
CLI Bordeaux Nord Aquitaine
Bordeaux, 33000, France
CLI Tivoli
Bordeaux, 33000, France
CH, Oncologie, Brive la Gaillarde,
Brive-la-Gaillarde, 19312, France
HOP Louis Pradel
Bron, 69677, France
CLI du Parc, Pneumo, Castelnau le Lez
Castelnau-le-Lez, 34170, France
Centre médical N de Pontoux, Oncologie, Chalon sur Saône
Chalon-sur-Saône, 71100, France
HOP de Chauny
Chauny, 02303, France
Centre Hospitalier Intercommunal, Oncolgie, Crétail
Créteil, 94010, France
HOP La Dracénie, Onco, Draguignan
Draguignan, 83300, France
HOP CHD La Roche sur Yon - Montaigu - Luçon, Pneumo
La Roche-sur-Yon, 85925, France
HOP CH Emile Roux Le Puy, Pneumo, Le puy en Velay
Le Puy-en-Velay, 43000, France
HOP Hôpital Robert Boulin, Pneumo, Libourne
Libourne, 33500, France
Hopital Privé Jean Mermoz
Lyon, 69008, France
HOP Saint Joseph et Saint Luc, Pneumo, Lyon
Lyon, 69365, France
CHG, Oncologie, Meaux
Meaux, 77104, France
CLI Clémentville
Montpellier, 34070, France
HOP Centre Hospitalier de Mulhouse, Pneumo, Mulhouse
Mulhouse, 68100, France
CTR d'Oncologie de Gentilly, Onco, Nancy
Nancy, 54100, France
CLI Polyclinique le Languedoc, Narbonne
Narbonne, 11100, France
CLI Polyclinique le Languedoc, Narbonne
Narbonne, 11108, France
CLI Saint-Pierre, Oncologie, Perpignan
Perpignan, 66000, France
CHR d'Annecy, Oncologie, Annecy
Pringy, 74374, France
HOP Cornouaille, Pneumo, Quimper
Quimper, 29000, France
CLI Les Bleuets, Pneumologie, Reims
Reims, 51100, France
HOP Centre Hospitalier de Saint Quentin, Pneumo, St-Quentin
Saint-Quentin, 02321, France
HOP Hôpitaux du Léman
Thonon-les-Bains, 74203, France
HOP HIA Saint-Anne
Toulon, 83800, France
CLI Pasteur
Toulouse, 31076, France
CLI Pasteur
Toulouse, 31300, France
Centre de Radiothérapie Marie Curie
Valence, 26000, France
HOP Nord Ouest de Villefranche, oncologie, Gleize
Villefranche-sur-Saône, 69655, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to low rates of investigator and patient recruitment, it appeared that it would not be possible to recruit the target patient population in an acceptable timeframe and the study was prematurely stopped
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2015
First Posted
June 26, 2015
Study Start
November 19, 2015
Primary Completion
February 27, 2017
Study Completion
February 27, 2017
Last Updated
March 1, 2019
Results First Posted
March 1, 2019
Record last verified: 2018-10