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Completed

NCT Number: NCT02896790

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint-André

Bordeaux, 33000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interviews with 2 oncologists and 10 patients

Other

Interviews with 15 patients

Other

Primary outcomes

  1. Health quality of life with QLQC30 questionnaire

    Time frame: Three years

Secondary outcomes

  1. Participation rate to the program stages

    Time frame: 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

  2. Number of rendez-vous changed by the patient

    Time frame: Two years

  3. Number of rendez-vous changed by the healers

    Time frame: Two years

  4. Number of therapeutic education procedures stages versus the number realized

    Time frame: Two years

  5. Number of calls by nurses

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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

Acronym: MODAP

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2016
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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