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)

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.

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 Overview

• Status: Completed
• Conditions: Metastatic Solid Tumor
• Intervention / Treatment: Other: Dedicated and coordinated follow-up; Other: Standard follow-up

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Albi, France, 81000
    • Clinique Claude Bernard
  • Castres, France, 81108
    • Centre Hospitalier Intercommunal Castres Mazamet
  • Cornebarrieu, France
    • Clinique des Cèdres
  • Toulouse, France, 31059
    • Institut Claudius Regaud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A	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: Arm B; Standard	Other: Standard follow-up; - Completion of QLQ-C30 and GIRERD questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: rate of patients who adhere to oral targeted therapy treatment administration.	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)	6 months per patient

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud
• Investigators: Principal Investigator: Christine CHEVREAU, MD, Institut Universitaire du Cancer Toulouse Oncopole

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2017
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Metastatic solid tumor; Treatment adherence; Oral Targeted Therapy
• Other Study ID Numbers: 17GENE02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No