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. (ADHESIPH)

Institut Claudius Regaud

Status: Completed

Conditions: Metastatic Solid Tumor

Treatments: Other: Standard follow-up; Other: Dedicated and coordinated follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT03263416

17GENE02

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Other: Dedicated and coordinated follow-up

Arm B

Other group

Description:

Standard

Treatment:

Other: Standard follow-up