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

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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

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
Advanced Cancer Ethics Other: interviews Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841124


Locations
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France
Centre Hospitalier Universitaire de Besançon
Besancon, France, 25000
Centre Hospitalier de Colmar
Colmar, France, 68000
Clinique Drevon
Dijon, France, 21000
Centre Hospitalier Universitaire St Antoine
Paris, France, 75012
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
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02841124    
Other Study ID Numbers: WHATELSE
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Decision making
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases