Clinical trial NCT02841124: Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies.
Official title: Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies : Physicians and Patients Points of View and Interactions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Ethics
Keywords: Decision making
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Saint Antoine, Paris
name: Centre de Lutte Contre le Cancer Alexis Vautrin, Vandoeuvre les Nancy
name: Centre Hospitalier de Colmar
name: Clinique Devron, Dijon
First posted: 2016-07-22
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility 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

Primary outcomes:
measure: interviews with physicians, patients and relatives
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: Centre Hospitalier Universitaire de Besançon
city: Colmar
country: France
facility: Centre Hospitalier de Colmar
city: Dijon
country: France
facility: Clinique Drevon
city: Paris
country: France
facility: Centre Hospitalier Universitaire St Antoine
city: Vandœuvre-lès-Nancy
country: France
facility: Centre de Luttre Contre le Cancer Alexis Vautrin
Study officials:
References: