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

Terminated

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT02483416
• Lead Sponsor: Boehringer Ingelheim

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:

Study Timeline

• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-06-24
• Study First Posted: 2015-06-26
• Study Start: 2015-11-19
• Primary Completion: 2017-02-27
• Study Completion: 2017-02-27
• Results First Submitted: 2018-02-26
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-31
• Last Update Submitted: 2018-10-31
• Results First Posted: 2019-03-01
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up.	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.

Secondary Outcome Measures

Name	Time	Method
Score (0-6) Obtained With the Girerd Questionnaire	at Day 30 (D30), Day 60 (D60) and Day 90 (D90)	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.
Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Decision of the Medical Team	3 months	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.
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 temporary or definitive interruption following the medical team decision.
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 dose reduction following decision of the medical team.; There were no participants with dose reduction hence the data is not available.
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following Patient Decision.	3 months	Cumulated dose of oral targeted therapy not taken due to temporary or definitive interruption following patient decision.; No patient without therapy following patient decision
Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up.	D30, D60 and D90	Duration of unplanned hospitalizations (related to the treatment) during the 3-month follow-up are presented
Number of Unplanned Visits to the Investigator During the 3-month Follow-up	D30, D60 and D90	Number of participants with unplanned visits to the investigator during the 3-month follow-up are presented
Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Patient Decision.	3 months	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
Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Patient Decision.	3 months	Cumulated dose of oral targeted therapy not taken due to dose reduction following patient decision. No participants with dose reduction.
Visual Analogue Scale (VAS) Score (0-10) for Overall Patient Satisfaction With the Level of Care (Information, Advice) at D90.	3 months	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.
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)	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.
Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up.	Day30 (D30), Day60 (D60) and Day90 (D90)	Number of participants with emergency admissions (related to the treatment) during the 3-month follow-up are presented
Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up	D30, D60, D90	Number of participants with unplanned hospitalizations (related to the treatment) during the 3-month follow-up is presented
Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up	D30, D60 and D90	Number of participants with unplanned visits to the general practitioner during the 3-month follow-up is presented
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	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.
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 general practitioner to the patient during the 3-month follow-up is presented
Number of Calls Made by the Medical Team to Their 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 is presented
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 participants with unplanned visits to a specialist, whatever is his specialty, other than the investigator during the 3-month follow-up is presented
Number of Calls Made by the Patients to Their Medical Team 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 is presented
VAS Score (0-10) for Overall Investigator Satisfaction With the Level of Patient Care at D90	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.
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	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.
Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.	D30, D60 and D90	Number of calls made by the patients to their general practitioner during the 3-month follow-up is presented
Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up	D30, D60, D90	Number of calls between the general practitioners and the medical teams during the 3-month follow-up is presented
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	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

Trial Locations

Locations (34)

HOP CHD La Roche sur Yon - Montaigu - Luçon, Pneumo; 🇫🇷 La Roche Sur Yon cedex, France

CHR d'Annecy, Oncologie, Annecy; 🇫🇷 Pringy, France

CLI Dr Calabet, Oncolgie, Agen; 🇫🇷 Agen, France

HOP Centre Hospitalier Pays d'Aix, Pneumo, Aix en Provence; 🇫🇷 Aix en Provence cedex 1, France

HOP Louis Pradel; 🇫🇷 Bron cedex, France

HOP Hôpitaux du Léman; 🇫🇷 Thonon les Bains, France

Hopital Privé Jean Mermoz; 🇫🇷 Lyon, France

HOP Centre Marie Curie, Onco, Arras; 🇫🇷 Arras, France

CLI Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

CLI Tivoli; 🇫🇷 Bordeaux, France

HOP Centre Hospitalier de Béziers, Pneumo, Béziers; 🇫🇷 Béziers, France

CLI Polyclinique du Parc Rambot, Pneumo, Aix en Provence; 🇫🇷 Aix en Provence, France

CTR d'Oncologie de Gentilly, Onco, Nancy; 🇫🇷 Nancy, France

CLI Saint-Pierre, Oncologie, Perpignan; 🇫🇷 Perpignan, France

CLI Clémentville; 🇫🇷 Montpellier, France

CH, Oncologie, Brive la Gaillarde,; 🇫🇷 Brive La Gaillarde cedex, France

CLI du Parc, Pneumo, Castelnau le Lez; 🇫🇷 Castelnau le lez, France

Centre médical N de Pontoux, Oncologie, Chalon sur Saône; 🇫🇷 Chalons Sur Saône, France

HOP de Chauny; 🇫🇷 Chauny, France

Centre Hospitalier Intercommunal, Oncolgie, Crétail; 🇫🇷 Creteil cedex, France

HOP La Dracénie, Onco, Draguignan; 🇫🇷 Draguignan, France

HOP Saint Joseph et Saint Luc, Pneumo, Lyon; 🇫🇷 Lyon cedex 07, France

HOP CH Emile Roux Le Puy, Pneumo, Le puy en Velay; 🇫🇷 Le Puy en Velay, France

HOP Hôpital Robert Boulin, Pneumo, Libourne; 🇫🇷 Libourne, France

CHG, Oncologie, Meaux; 🇫🇷 Meaux cedex, France

HOP Cornouaille, Pneumo, Quimper; 🇫🇷 Quimper, France

HOP Centre Hospitalier de Mulhouse, Pneumo, Mulhouse; 🇫🇷 Mulhouse, France

CLI Polyclinique le Languedoc, Narbonne; 🇫🇷 Narbonne, France

HOP Centre Hospitalier de Saint Quentin, Pneumo, St-Quentin; 🇫🇷 Saint-Quentin cedex, France

CLI Les Bleuets, Pneumologie, Reims; 🇫🇷 Reims, France

HOP HIA Saint-Anne; 🇫🇷 Toulon, France

HOP Nord Ouest de Villefranche, oncologie, Gleize; 🇫🇷 Villefranche sur Saône Cedex, France

CLI Pasteur; 🇫🇷 Toulouse, France

Centre de Radiothérapie Marie Curie; 🇫🇷 Valence, France