ADHESIPH: 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.
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.
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
|Experimental: Arm A
Other: Dedicated 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
|Other: Arm B
Other: Standard follow-up
- Completion of QLQ-C30 and GIRERD questionnaires
Primary Outcome Measures
- 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 Outcome Measures
- 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]
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
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
Contacts and Locations
|1||Clinique Claude Bernard||Albi||France||81000|
|2||Centre Hospitalier Intercommunal Castres Mazamet||Castres||France||81108|
|3||Clinique Des Cedres||Cornebarrieu||France|
|4||Institut Claudius Regaud||Toulouse||France||31059|
Sponsors and Collaborators
- Institut Claudius Regaud
- Principal Investigator: Christine CHEVREAU, MD, Institut Universitaire du Cancer Toulouse Oncopole
Study Documents (Full-Text)None provided.