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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Completed
CT.gov ID
NCT02841124
Collaborator
Centre Hospitalier Universitaire Saint Antoine, Paris (Other), Centre de Lutte Contre le Cancer Alexis Vautrin, Vandoeuvre les Nancy (Other), Hospital Center De Colmar (Other), Clinique Devron, Dijon (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: interviews
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies : Physicians and Patients Points of View and Interactions.
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Other: Qualitative research

Semi-structured interviews

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)

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Universitaire de Besançon Besancon France 25000
2 Centre Hospitalier de Colmar Colmar France 68000
3 Clinique Drevon Dijon France 21000
4 Centre Hospitalier Universitaire St Antoine Paris France 75012
5 Centre de Luttre Contre le Cancer Alexis Vautrin Vandœuvre-lès-Nancy France 54519

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon
  • Centre Hospitalier Universitaire Saint Antoine, Paris
  • Centre de Lutte Contre le Cancer Alexis Vautrin, Vandoeuvre les Nancy
  • Hospital Center De Colmar
  • Clinique Devron, Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT02841124
Other Study ID Numbers:
  • WHATELSE
First Posted:
Jul 22, 2016
Last Update Posted:
Jul 27, 2016
Last Verified:
Jul 1, 2016
Keywords provided by Centre Hospitalier Universitaire de Besancon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2016