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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institut Claudius Regaud
- Enrollment
- 186
- Locations
- 7
- Primary Endpoint
- Efficacy: rate of patients who adhere to oral targeted therapy treatment administration.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Efficacy: rate of patients who adhere to oral targeted therapy treatment administration.
Time Frame: 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 Outcomes
- 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)