- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02854293
Impact of a Booklet-Question List on Cancer Patients or Their Families Seeking Prognostic Information During a Palliative Care Consultation (QUEPAL)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69008
- Léon Berard
-
Nancy, France, 54519
- Centre Alexis Vautrin
-
Paris, France, 75005
- Institut Curie
-
Saint-Cloud, France, 92210
- Hopital René Huguenin
-
Tarbes, France, 65000
- Polyclinique de l'Ormeau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Booklet-Question List (BQL) group
76 patients
|
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
Sponsor
Investigators
- Principal Investigator: Carole Bouleuc, MD, Institut Curie
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IC 2011-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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