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

Metastatic Cancer Clinical Trial

— QUEPAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854293
• Other study ID #: 2011-04
• Status: Completed
• Phase: N/A
• First received: July 27, 2016
• Last updated: August 2, 2016
• Start date: May 2012
• Est. completion date: May 2015

Study information

• Verified date: July 2016
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Palliative Care

Intervention

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

Locations

Country	Name	City	State
France	Léon Berard	Lyon
France	Centre Alexis Vautrin	Nancy
France	Institut Curie	Paris
France	Hopital René Huguenin	Saint Cloud
France	Polyclinique de l'Ormeau	Tarbes

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		one month	No
Secondary	HADS (Hospital Anxiety and Depression Scale) anxiety and depression score		one month	No
Secondary	QLQC-15Pal palliative quality of life score	The EORTC QLQ-C15-PAL is a questionnaire developed to assess the quality of life of palliative cancer care patients	one month	No
Secondary	MB coping questionnaire score	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	No
Secondary	Two 5-point Likert scales on information needs and satisfaction with medical information		one month	No
Secondary	Specific questionnaire on the Booklet-Question List (mode of use, satisfaction)		one month	No