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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841124
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : July 27, 2016
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Saint Antoine, Paris
Centre de Lutte Contre le Cancer Alexis Vautrin, Vandoeuvre les Nancy
Hospital Center De Colmar
Clinique Devron, Dijon
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Tracking Information
First Submitted Date  ICMJE July 19, 2016
First Posted Date  ICMJE July 22, 2016
Last Update Posted Date July 27, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
interviews with physicians, patients and relatives [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies.
Official Title  ICMJE Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies : Physicians and Patients Points of View and Interactions.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Advanced Cancer
  • Ethics
Intervention  ICMJE 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)
Study Arms  ICMJE Qualitative research
Semi-structured interviews
Intervention: Other: interviews
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2016)
21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02841124
Other Study ID Numbers  ICMJE WHATELSE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Collaborators  ICMJE
  • 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  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP