Metastatic Solid Tumor
Conditions
Keywords
Metastatic solid tumor, Oral Targeted Therapy, Treatment adherence
Brief summary
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.
Interventions
OTHERDedicated and coordinated follow-up
* 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
OTHERStandard follow-up
\- Completion of QLQ-C30 and GIRERD questionnaires
Sponsors
Institut Claudius Regaud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient with a metastatic solid tumor and starting a first cycle of oral targeted therapy whatever the treatment line 2. Age \> or = 18 years old 3. Affiliated to the french social security system 4. Patient must provide written informed consent prior to any study-specific procedure or assessment
Exclusion criteria
1. Patient not available by phone or with no caregiver who can answer the phone for him 2. Pregnant or breastfeeding women 3. 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 4. Patient protected by law
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: rate of patients who adhere to oral targeted therapy treatment administration. | 6 months per patient | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Safety according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03 | 6 months per patient |
| 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 |
Countries
France
Outcome results
None listed