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

Not Applicable

Completed

• Conditions: Ethics; Advanced Cancer
• Interventions: Other: interviews

• Registration Number: NCT02841124
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2016-07
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-22
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Qualitative research	interviews	Semi-structured interviews

Primary Outcome Measures

Name	Time	Method
interviews with physicians, patients and relatives	6 months	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.

Trial Locations

Locations (5)

Centre Hospitalier de Colmar; 🇫🇷 Colmar, France

Centre Hospitalier Universitaire St Antoine; 🇫🇷 Paris, France

Centre de Luttre Contre le Cancer Alexis Vautrin; 🇫🇷 Vandœuvre-lès-Nancy, France

Clinique Drevon; 🇫🇷 Dijon, France

Centre Hospitalier Universitaire de Besançon; 🇫🇷 Besancon, France