Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02896790
Acronym
MODAP
Enrollment
24
Registered
2016-09-12
Start date
2015-03-09
Completion date
2017-04-30
Last updated
2017-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Services Research

Keywords

Cancer, Oral Therapy, Compliance, Anthropology, Psychology

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).

Interventions

OTHERInterviews with 2 oncologists and 10 patients
OTHERInterviews with 15 patients

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Health quality of life with QLQC30 questionnaireThree years

Secondary

MeasureTime frameDescription
Participation rate to the program stagesTwo yearsQuantitative 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 patientTwo years
Number of rendez-vous changed by the healersTwo years
Number of therapeutic education procedures stages versus the number realizedTwo years
Number of calls by nursesTwo yearsManagement 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026