Assesment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy (CHIMIO ORALE)

Assessment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy

Therapeutic education is an effective way to support the prescription of oral chemotherapy in oncology. It aims to increase adherence to treatment, to better control the side effects and reduce unplanned readmissions. The three major oncology institutions in the Rhône-Alpes region (Hospices Civils de Lyon, the Centre Léon Bérard Cancer Institute and Lucien Neuwirth) decided to collaborate on a project to implement an adapted Therapeutic Education Program context of each of these institutions.

The objective of this study is to evaluate the implementation of the intervention in the 3 participating centers, over 1 year:

1. Assess the achievement of the target population
2. Evaluate the adaptation of intervention in context
3. Evaluate the effectiveness of the intervention (impact): effectiveness in real life, identification of interactions with the environment linked to the center, identification of unintended effects of the intervention.
4. Assessing the sustainability of the intervention

Study Overview

• Status: Unknown
• Conditions: Neoplasm
• Intervention / Treatment: Behavioral: therapeutic education program

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurélie BOURMAUD, MD; Phone Number: 04 77 91 74 77; Email: aurelie.bourmaud@icloire.fr

Study Locations

• France
  • Lyon, France, 69008
    • Recruiting
    • Centre Léon Bérard
    • Contact: David PEROL, MD
  • Pierre Bénite, France, 69310
    • Recruiting
    • CH Lyon sud
    • Contact: Claire Falandry, PhDMD
  • Saint-Priest-en-Jarez, France, 42270
    • Recruiting
    • institut de cancérologie Lucien Neuwirth
    • Contact: Cécile Vassal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient care in medical oncology services of the Cancer Institute of Lucien Neuwirth, the Lyon-Sud hospital and the Centre Léon Bérard:
• Age over 18 years
• Introducing an active cancer (local extension, locoregional or metastatic)
• Oral chemotherapy as monotherapy or in combination with other treatments, initiated or in progress

Exclusion Criteria:

• Refusal to participate, protected adult patient under guardianship.
• Patient disability to understand the course of the study, the Therapeutic education program, or failure to follow the educational sessions.
• Patient with documented history of cognitive or psychiatric disorders.
• Patient on adjuvant therapy or hormone therapy for prostate cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: therapeutic education program; therapeutic education program which aims is to improve the adherence to the treatment and management of adverse effects of this treatment in patients taking an oral chemotherapy for active cancer	Behavioral: therapeutic education program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of affected population		3 months
Level of acquisition of knowledge	Questionnaire composed of numerous questions dealing with patient's knowledge about his/her disease, treatment and treatment's side effects . Answers are quoted in Yes/No and a global scoring is made with all answers. Final measure is a percentage of good answers.	3 months
Anxiety and Depression	measured with the Hospital Anxiety Depression Scale (Zigmond & Snaith, 1983 ), wich gives separated results about the level of anxiety and of depression according to the level of scoring to a set of 14 questions. Questions are rated from 0-3, and the anxiety and depression subscale scores range from 0-21. The cutoff for each subscale is eight.	3 months
Quality of Life Questionnaire		3 months
Morisky Measurement Adherence Scale		3 months

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de la Loire
• Collaborators: Centre Leon Berard; Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2014-12 (Other Identifier: AP HM)

Plan for Individual participant data (IPD)

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