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

NCT02896790 | Completed

• 1 other identifier: CHUBX 2014/31
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Health Services Research

Keywords

Cancer; Oral Therapy; Compliance; Anthropology; Psychology

Outcome Measures

Primary Outcomes (1)

• Health quality of life with QLQC30 questionnaire

  Three years

Secondary Outcomes (5)

• Participation rate to the program stages

  Two years

• Number of rendez-vous changed by the patient

  Two years

• Number of rendez-vous changed by the healers

  Two years

• Number of therapeutic education procedures stages versus the number realized

  Two years

• Number of calls by nurses

  Two years

Study Arms (2)

Stage 1

Patients without therapeutic education

Other: Interviews with 2 oncologists and 10 patients

Stage 2

Patients with therapeutic education

Other: Interviews with 15 patients

Interventions

Interviews with 2 oncologists and 10 patients OTHER

Stage 1

Interviews with 15 patients OTHER

Stage 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Metastatic Renal cancer

You may qualify if:

• 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)

You may not qualify if:

• History of other cancer
• History of severe psychiatric affection

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hôpital Saint-André

Bordeaux, 33000, France

Location

Related 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.

  PMID: 20418205 BACKGROUND

• 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.

  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.

  PMID: 21382797 BACKGROUND

• 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.

  PMID: 20649809 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Patient Compliance

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Hélène HOARAU, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: September 12, 2016
• Study Start: March 9, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 26, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)