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

Neoplasm Clinical Trial

— CHIMIO ORALE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02828449
• Other study ID #: 2014-12
• Status: Recruiting
• Phase: N/A
• First received: February 25, 2016
• Last updated: September 13, 2017
• Start date: November 2016
• Est. completion date: March 2018

Study information

• Verified date: September 2017
• Source: Institut de Cancérologie de la Loire
• Contact: Aurélie BOURMAUD, MD
• Phone: 04 77 91 74 77
• Email: aurelie.bourmaud[@]icloire.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm

Intervention

Behavioral:
• therapeutic education program

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon
France	CH Lyon Sud	Pierre Bénite
France	Institut de Cancérologie Lucien Neuwirth	Saint-Priest-en-Jarez

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire	Centre Leon Berard, Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of affected population		3 months
Primary	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
Primary	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
Primary	Quality of Life Questionnaire		3 months
Primary	Morisky Measurement Adherence Scale		3 months