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

Health Services Research Clinical Trial

— MODAP  

Official title:

From the Model to the Adaptation of a Therapeutic Education Program in Cancer Research: the Case of Renal Cancer Patients Treated by Oral Treatments, Multidisciplinary Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896790
• Other study ID #: CHUBX 2014/31
• Status: Completed
• Phase: N/A
• First received: June 27, 2016
• Last updated: July 25, 2017
• Start date: March 9, 2015
• Est. completion date: April 2017

Study information

• Verified date: July 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Services Research

Intervention

Other:
• Interviews with 2 oncologists and 10 patients

• Interviews with 15 patients

Locations

Country	Name	City	State
France	Hôpital Saint-André	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (4)

Gross-Goupil M, Escudier B. [Targeted therapies: sequential and combined treatments]. Bull Cancer. 2010;97:65-71. doi: 10.1684/bdc.2010.1071. French. — View Citation

Hoarau H, Giacomoni C, Etienne G, Fort MP, Mahon FX, Ceccaldi J, Reiffers J, Monnereau A. Expérience quotidienne des patients atteints de LMC traités par voie orale : déterminants des pratiques d'observance ?. Oncologie, 2012, n° 14, p. 609-612.

Regnier Denois V, Poirson J, Nourissat A, Jacquin JP, Guastalla JP, Chauvin F. Adherence with oral chemotherapy: results from a qualitative study of the behaviour and representations of patients and oncologists. Eur J Cancer Care (Engl). 2011 Jul;20(4):520-7. doi: 10.1111/j.1365-2354.2010.01212.x. Epub 2010 Jul 23. — View Citation

Santucci R, Aatmani AE, Lescoute A, Levêque D, Serra S, Bergerat JP, Beretz L, Herbrecht R. [Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. Bull Cancer. 2011 Feb;98(2):176-81. doi: 10.1684/bdc.2011.1308. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health quality of life with QLQC30 questionnaire		Three years
Secondary	Participation rate to the program stages	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	Two years
Secondary	Number of rendez-vous changed by the patient		Two years
Secondary	Number of rendez-vous changed by the healers		Two years
Secondary	Number of therapeutic education procedures stages versus the number realized		Two years
Secondary	Number of calls by nurses	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	Two years