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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.

NCT03263416 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2022-01-31

No results posted yet for this study

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.

Conditions

  • Metastatic Solid Tumor

Interventions

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

Standard follow-up

\- Completion of QLQ-C30 and GIRERD questionnaires

Sponsors & Collaborators

  • Institut Claudius Regaud

    lead OTHER

Principal Investigators

  • Christine CHEVREAU, MD · Institut Universitaire du Cancer Toulouse Oncopole

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-24
Primary Completion
2022-01-25
Completion
2022-01-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03263416 on ClinicalTrials.gov