Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies.

Advanced Cancer Clinical Trial

— WHATELSE  

Official title:

Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies : Physicians and Patients Points of View and Interactions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841124
• Other study ID #: WHATELSE
• Status: Completed
• Phase: N/A
• First received: July 19, 2016
• Last updated: July 26, 2016
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The decision to limit or withdraw specific therapies (DLWT) in patients with advanced cancer is a complex process that is always painful for patients, relatives and professionals. For more than 10 years, shared decision making has been more and more emphasized. However, few data in the literature rely on clinical research. In order to understand their difficulties and issues, this study explores the determinants and modalities of DLWT and analyses the feasibility of different methods for investigating this decision making process.

Description:

This study explores the decision-making process for patients with advanced cancer when the question to imit or withdraw specific therapies (DLWT) is raised, with a cross-analysis of physicians and pts points of view.

This study took place in 5 oncology and hematology units : 2 university hospitals, 1 general hospital, 1 cancer center and 1 private hospital. The study included two different approaches: an epidemiological section to identify the prevalence of these situations in different institutions and a qualitative study section exploring factors influencing the decision process. The epidemiological analysis included all hospitalized patients identified with advanced cancer for whom the question of DLWT was raised in a given week or during the two weeks preceding the investigation.

The qualitative analysis was based on interviews with the referent oncologist (or hematologist) and his patient (conducted by a physician and a psychologist respectively) as well as interviews with other partners involved in the situation (care staff and relatives) depending on the center. Researchers also participated in multidisciplinary meetings and monitored changes in the decision over a three month period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with advanced cancer

• Existence of a questioning about DLWT

• Absence of guide lines

Exclusion Criteria:

• Incapacity of the patient to participate to an interview

• Absence of informed consent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Advanced Cancer
• Ethics
• Neoplasms

Intervention

Other:
• interviews
face-to-face interviews with the referent oncologist (or hematologist) and his patient (conducted by a physician and a psychologist respectively) as well as interviews with other partners involved in the situation (care staff and relatives)

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besancon
France	Centre Hospitalier de Colmar	Colmar
France	Clinique Drevon	Dijon
France	Centre Hospitalier Universitaire St Antoine	Paris
France	Centre de Luttre Contre le Cancer Alexis Vautrin	Vandœuvre-lès-Nancy

Sponsors (5)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Centre de Lutte Contre le Cancer Alexis Vautrin, Vandoeuvre les Nancy, Centre Hospitalier de Colmar, Centre Hospitalier Universitaire Saint Antoine, Paris, Clinique Devron, Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interviews with physicians, patients and relatives	A thematic analysis induces the creation of a set of themes and concepts clustered by relevance into a tree structure. The thematic tree structure constitutes the dataset of interest.	6 months	No