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

NCT ID: NCT02828449

Last Updated: 2017-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-03-31

Brief Summary

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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

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Conditions

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Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

therapeutic education program

Intervention Type BEHAVIORAL

Interventions

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therapeutic education program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role collaborator

Centre Leon Berard

OTHER

Sponsor Role collaborator

Institut de Cancérologie de la Loire

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Léon Bérard

Lyon, , France

Site Status RECRUITING

CH Lyon Sud

Pierre-Bénite, , France

Site Status RECRUITING

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Aurélie BOURMAUD, MD

Role: CONTACT

04 77 91 74 77

Facility Contacts

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David PEROL, MD

Role: primary

Claire Falandry, PhDMD

Role: primary

Cécile Vassal, MD

Role: primary

Other Identifiers

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2014-12

Identifier Type: -

Identifier Source: org_study_id

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