From the Model to the Adaptation of a Therapeutic Education Program (TEP) in Cancer Research

Completed

• Conditions: Health Services Research
• Interventions: Other: Interviews with 15 patients; Other: Interviews with 2 oncologists and 10 patients

• Registration Number: NCT02896790
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

The use of oral targeted therapies draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals \[1,2\]. These therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. This situation underlines the importance of a therapeutic education to accompany this "learning" \[3\]. Nevertheless, in France, the therapeutic educational programs, built according to the "standards" of the therapeutic education (TE), are still very rare in cancer research \[4\]. In May 2012, a therapeutic educational program for these patients has been developed in the oncology department of the Teaching Hospital of Bordeaux through a multidisciplinary team. This program, dedicated to metastatic renal cancer patients treated by oral targeted therapies, becomes here an object of research: MODAP (action-research).

Detailed Description

At the diagnosis, 25 to 30 % of renal cancer patients present a metastatic disease. The prognosis remains dark in spite of the advent of the targeted therapies from 2007. Actually, the use of oral targeted therapies, most of the time carried out on an outpatient basis (sunitinib in particular), draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals \[1,2\].

These therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. This situation underlines the importance of a therapeutic education to accompany this "learning" \[3\]. Nevertheless, the therapeutic educational programs, built according to the "standards" of the therapeutic education (TE), are still very rare in cancer research \[4\]: multiplicity of the pathology (a cancer, cancers), multiplicity of the patients' experiences, the difficulty of implementation? In May 2012, in front of the experience told by the patients and the professionals in the context of metastatic renal cancer, the members of the oncology department of the Teaching Hospital of Bordeaux, the therapeutic educational Federation, the Coordination Cancer Centre (3C), an anthropologist, an expert patient and a patient's association developed a therapeutic educational program for these patients \[current approval\].

This program, built on the model of the TE in France, becomes here an object of research: MODAP (action-research).

Study Timeline

• Study Start: 2015-03-09
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age = 18 years old
• Metastatic Renal cancer (carcinoma with clear cells and other subcategories)
• Indication of a first line of treatment of therapy targeted by Sutent ©
• General WHO 0-2 state
• Life expectancy = 12 weeks
• Agree to participate in MODAP (Therapeutic Education)

Exclusion Criteria

• History of other cancer
• History of severe psychiatric affection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage 2	Interviews with 15 patients	Patients with therapeutic education
Stage 1	Interviews with 2 oncologists and 10 patients	Patients without therapeutic education

Primary Outcome Measures

Name	Time	Method
Health quality of life with QLQC30 questionnaire	Three years

Secondary Outcome Measures

Name	Time	Method
Participation rate to the program stages	Two years	Quantitative data analysis of questionnaires about the health program satisfaction Participation rate to the program stages Attendance to the program stages Management of therapeutic plan : number of rendez-vous changed by the patient or healers
Number of rendez-vous changed by the healers	Two years
Number of calls by nurses	Two years	Management of therapeutic plan : number of rendez-vous change by the patient or healers, number of therapeutic education procedures stages versus the number realized, number of calls by nurses
Number of rendez-vous changed by the patient	Two years
Number of therapeutic education procedures stages versus the number realized	Two years

Trial Locations

Locations (1)

Hôpital Saint-André; 🇫🇷 Bordeaux, France