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

NCT ID: NCT02841124

Last Updated: 2016-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Advanced Cancer Ethics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Qualitative research

Semi-structured interviews

Group Type OTHER

interviews

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Saint Antoine, Paris

UNKNOWN

Sponsor Role collaborator

Centre de Lutte Contre le Cancer Alexis Vautrin, Vandoeuvre les Nancy

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier de Colmar

OTHER

Sponsor Role collaborator

Clinique Devron, Dijon

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire de Besançon

Besançon, , France

Site Status

Centre Hospitalier de Colmar

Colmar, , France

Site Status

Clinique Drevon

Dijon, , France

Site Status

Centre Hospitalier Universitaire St Antoine

Paris, , France

Site Status

Centre de Luttre Contre le Cancer Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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WHATELSE

Identifier Type: -

Identifier Source: org_study_id

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