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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02828449
Other study ID # 2014-12
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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