Impact of a Booklet-Question List on Cancer Patients or Their Families Seeking Prognostic Information During a Palliative Care Consultation (QUEPAL)

August 2, 2016 updated by: Institut Curie
Prospective, randomized, multicentre phase III study to evaluate the level and type of information requested by patients or families during a palliative care consultation after they have been given the Booklet-Question List (BQL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69008
        • Léon Berard
      • Nancy, France, 54519
        • Centre Alexis Vautrin
      • Paris, France, 75005
        • Institut Curie
      • Saint Cloud, France, 92210
        • Hôpital René Huguenin
      • Tarbes, France, 65000
        • Polyclinique de l'Ormeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient followed for metastatic cancer with or without specific treatment, with a limited life expectancy

Description

Inclusion criteria:

  • Patient over the age of 18 years,
  • Patient who has signed the informed consent form after being given a written information sheet
  • Patient followed for metastatic cancer with or without specific treatment, with a limited life expectancy
  • Patient referred to the palliative care team.
  • French-speaking Patient

Exclusion criteria:

  • Cognitive disorders
  • Documented psychiatric disorders or marked psychological fragility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Booklet-Question List (BQL) group
76 patients
Other: Booklet-Question List

Booklet-Question List (BQL) proposed in palliative cares, divided into 8 chapters, given to the patient before the first palliative care consultation.

Providing a list of questions to patients and their families without any obligations allows individual adaptation of information; patients or families who are afraid of asking these questions can take advantage of this opportunity, while respecting the need to avoid these subjects for other patients
control group

Conventional palliative management

76 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of questions asked or the concerns expressed that elicit a medical comment by the patient or the family during the palliative care consultation.
Time Frame: one month
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HADS (Hospital Anxiety and Depression Scale) anxiety and depression score
Time Frame: one month
one month
QLQC-15Pal palliative quality of life score
Time Frame: one month
The EORTC QLQ-C15-PAL is a questionnaire developed to assess the quality of life of palliative cancer care patients
one month
MB coping questionnaire score
Time Frame: one month
The Brief COPE is the abbreviated version of the COPE Inventory and assesses dispositional as well as situational coping efforts . The 28-item Brief COPE (consisting of 14 subscales) has acceptable psychometric properties and has been used extensively to examine the relationship between various coping strategies and psychological outcomes
one month
Two 5-point Likert scales on information needs and satisfaction with medical information
Time Frame: one month
one month
Specific questionnaire on the Booklet-Question List (mode of use, satisfaction)
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

  • Principal Investigator: Carole Bouleuc, MD, Institut Curie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-04 (Other Identifier: AP HM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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