NCT02841124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

7 months

First QC Date

July 19, 2016

Last Update Submit

July 26, 2016

Conditions

Advanced CancerEthics

Keywords

Decision making

Outcome Measures

Primary Outcomes (1)

  • interviews with physicians, patients and relatives

    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.

    6 months

Study Arms (1)

Qualitative research

OTHER

Semi-structured interviews

Other: interviews

Interventions

interviewsOTHER

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)

Qualitative research

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with advanced cancer
  • Existence of a questioning about DLWT
  • Absence of guide lines

You may not qualify if:

  • Incapacity of the patient to participate to an interview
  • Absence of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre Hospitalier Universitaire de Besançon

Besançon, 25000, France

Location

Centre Hospitalier de Colmar

Colmar, 68000, France

Location

Clinique Drevon

Dijon, 21000, France

Location

Centre Hospitalier Universitaire St Antoine

Paris, 75012, France

Location

Centre de Luttre Contre le Cancer Alexis Vautrin

Vandœuvre-lès-Nancy, 54519, France

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 22, 2016

Study Start

January 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

FR(5)