ADHESIPH: 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.

Sponsor

Institut Claudius Regaud (Other)

Overall Status

Completed

CT.gov ID

NCT03263416

Collaborator

(none)

186

Enrollment

Locations

Arms

54.1

Actual Duration (Months)

46.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Solid Tumor	Other: Dedicated and coordinated follow-up Other: Standard follow-up	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

186 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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.

Actual Study Start Date :

Jul 24, 2017

Actual Primary Completion Date :

Jan 25, 2022

Actual Study Completion Date :

Jan 25, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient with a metastatic solid tumor and starting a first cycle of oral targeted therapy whatever the treatment line
Age > or = 18 years old
Affiliated to the french social security system
Patient must provide written informed consent prior to any study-specific procedure or assessment

Exclusion Criteria:

Patient not available by phone or with no caregiver who can answer the phone for him
Pregnant or breastfeeding women
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
Patient protected by law

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique Claude Bernard	Albi	France	81000
2	Centre Hospitalier Intercommunal Castres Mazamet	Castres	France	81108
3	Clinique Des Cedres	Cornebarrieu	France
4	Institut Claudius Regaud	Toulouse	France	31059

Sponsors and Collaborators

Institut Claudius Regaud

Investigators

Principal Investigator: Christine CHEVREAU, MD, Institut Universitaire du Cancer Toulouse Oncopole

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Claudius Regaud

ClinicalTrials.gov Identifier:

NCT03263416

Other Study ID Numbers:

17GENE02

First Posted:

Aug 28, 2017

Last Update Posted:

Jan 31, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institut Claudius Regaud

Metastatic solid tumor

Oral Targeted Therapy

Treatment adherence

Study Results

No Results Posted as of Jan 31, 2022