Clinical trial NCT03263416: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Solid Tumor
Keywords: Metastatic solid tumor
Oral Targeted Therapy
Treatment adherence
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: rate of patients who adhere to oral targeted therapy treatment administration.
timeFrame: 6 months per patient
Secondary outcomes:
measure: Evaluation of the number of drug adaptations proposed by the Center Pharmacist following the pharmaceutical conciliation
timeFrame: 6 months per patient
measure: Quality of life using the QLQ-C30 questionnaire
timeFrame: 6 months per patient
measure: Safety according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03
timeFrame: 6 months per patient
Other outcomes:
Locations:
city: Albi
country: France
facility: Clinique Claude Bernard
city: Castres
country: France
facility: Centre Hospitalier Intercommunal Castres Mazamet
city: Cornebarrieu
country: France
facility: Clinique Des Cedres
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Institut Universitaire du Cancer Toulouse Oncopole
name: Christine CHEVREAU, MD
role: PRINCIPAL_INVESTIGATOR
References: