Study Evaluating Treatment Adherence in Patients Treated With Oral Targeted Therapy in Oncology Supported by a Dedicated and Coordinated Follow-up Compared to Standard Follow-up.

Study Overview
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Brief Summary
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This is a prospective, comparative, open label, randomized, multicentric study evaluating the benefit of a dedicated and coordinated follow-up on treatment adherence in patients with metastatic solid tumor and starting a first cycle of treatment compared to standard follow-up. A dedicated and coordinated follow-up during the treatment period will be based on a telephone follow-up and a pharmaceutical conciliation. Patients will be randomized into one of two study arms: Arm A (Experimental follow-up): coordinated follow-up performed by a dedicated nurse and a pharmaceutical conciliation made by the Center Pharmacist. Arm B: Standard follow-up during the treatment period. Patients will be followed during 6 months.

Official Title
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Regional, Multicentric, Randomized Study Evaluating Treatment Adherence in Patients Treated With Oral Targeted Therapy in Oncology Supported by a Dedicated and Coordinated Follow-up (Using a Telephone Follow-up by a Nurse and a Pharmaceutical Conciliation) Compared to Standard Follow-up.

Conditions
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Metastatic Solid Tumor

Intervention / Treatment
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* Other: Dedicated and coordinated follow-up
* Other: Standard follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with a metastatic solid tumor and starting a first cycle of oral targeted therapy whatever the treatment line Age > or = 18 years old Affiliated to the french social security system Patient must provide written informed consent prior to any study-specific procedure or assessment Exclusion Criteria: Patient not available by phone or with no caregiver who can answer the phone for him Pregnant or breastfeeding women Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure Patient protected by law

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Other: Dedicated and coordinated follow-up<br>* Coordinated follow-up performed by a dedicated nurse with consultations (before treatment initiation and during treatment) and a telephone follow-up during treatment period Pharmaceutical conciliation before treatment initiation made by the Center Pharmacist Completion of QLQ-C30 and GIRERD questionnaires<br>|
| Other: Arm B<br>Standard | Other: Standard follow-up<br>* - Completion of QLQ-C30 and GIRERD questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: rate of patients who adhere to oral targeted therapy treatment administration. | This outcome will be assessed by the counting of tablets and the completion of the GIRERD questionnaire by the patient (assessment performed at 1, 3 and 6 months during the treatment) | 6 months per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the number of drug adaptations proposed by the Center Pharmacist following the pharmaceutical conciliation |  | 6 months per patient | 
| Quality of life using the QLQ-C30 questionnaire |  | 6 months per patient | 
| Safety according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03 |  | 6 months per patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic solid tumor, Oral Targeted Therapy, Treatment adherence