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

NCT ID: NCT02896790

Last Updated: 2017-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-09

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Health Services Research

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stage 1

Patients without therapeutic education

Interviews with 2 oncologists and 10 patients

Intervention Type OTHER

Stage 2

Patients with therapeutic education

Interviews with 15 patients

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interviews with 2 oncologists and 10 patients

Intervention Type OTHER

Interviews with 15 patients

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hélène HOARAU, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Saint-André

Bordeaux, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND
PMID: 20418205 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 21382797 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20649809 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHUBX 2014/31

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cancer Fatigue Education Program
NCT01278147 COMPLETED NA
CAncer, NUtrition and Taste 2
NCT05027490 COMPLETED NA
Nutrition and Chemotherapy
NCT03840213 UNKNOWN