Clinical trial NCT02896790: From the Model to the Adaptation of a Therapeutic Education Program (TEP) in Cancer Research
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Services Research
Keywords: Cancer
Oral Therapy
Compliance
Anthropology
Psychology
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Metastatic Renal cancer

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).

Eligibility criteria: 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

Primary outcomes:
measure: Health quality of life with QLQC30 questionnaire
timeFrame: Three years
Secondary outcomes:
measure: Participation rate to the program stages
timeFrame: Two years
measure: Number of rendez-vous changed by the patient
timeFrame: Two years
measure: Number of rendez-vous changed by the healers
timeFrame: Two years
measure: Number of therapeutic education procedures stages versus the number realized
timeFrame: Two years
measure: Number of calls by nurses
timeFrame: Two years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Saint-André
Study officials:
affiliation: University Hospital, Bordeaux
name: Hélène HOARAU, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gross-Goupil M, Escudier B. [Targeted therapies: sequential and combined treatments]. Bull Cancer. 2010;97:65-71. doi: 10.1684/bdc.2010.1071. French.
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.
citation: Santucci R, Aatmani AE, Lescoute A, Leveque 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.
citation: 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.