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

Institut de Cancérologie de la Loire

Status: Unknown

Conditions: Neoplasm

Treatments: Behavioral: therapeutic education program

Study type: Interventional

Funder types: Other

Identifiers

NCT02828449

2014-12 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

therapeutic education program

Experimental group

Description:

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

Treatment:

Behavioral: therapeutic education program