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

Not Applicable

• Conditions: Neoplasm
• Interventions: Behavioral: therapeutic education program

• Registration Number: NCT02828449
• Lead Sponsor: Institut de Cancérologie de la Loire

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-11
• Study Start: 2016-11
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14
• Primary Completion: 2017-12
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
therapeutic education program	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

Primary Outcome Measures

Name	Time	Method
percentage of affected population	3 months
Level of acquisition of knowledge	3 months	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.
Anxiety and Depression	3 months	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.
Quality of Life Questionnaire	3 months
Morisky Measurement Adherence Scale	3 months

Trial Locations

Locations (3)

Institut de Cancérologie Lucien Neuwirth; 🇫🇷 Saint-Priest-en-Jarez, France

Centre Léon Bérard; 🇫🇷 Lyon, France

CH Lyon Sud; 🇫🇷 Pierre Bénite, France