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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Other | Standard |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dedicated and coordinated follow-up | Other |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine CHEVREAU, MD | Institut Universitaire du Cancer Toulouse Oncopole | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Claude Bernard | Albi | 81000 | France | |||
| Centre Hospitalier Intercommunal Castres Mazamet |
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|
| Standard follow-up | Other | - Completion of QLQ-C30 and GIRERD questionnaires |
|
| Safety according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03 | 6 months per patient |
| Castres |
| 81108 |
| France |
| Clinique Des Cedres | Cornebarrieu | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015438 | Health Behavior |
| D001519 | Behavior |
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