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.

Not Applicable

Completed

• Conditions: Metastatic Solid Tumor
• Interventions: Other: Dedicated and coordinated follow-up; Other: Standard follow-up

• Registration Number: NCT03263416
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-24
• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-28
• Status Verified: 2022-01
• Primary Completion: 2022-01-25
• Study Completion: 2022-01-25
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Dedicated and coordinated follow-up	-
Arm B	Standard follow-up	Standard

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Clinique Des Cedres; 🇫🇷 Cornebarrieu, France

Clinique Claude Bernard; 🇫🇷 Albi, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Centre Hospitalier Intercommunal Castres Mazamet; 🇫🇷 Castres, France