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

NCT02854293 | Completed DMC

• 1 other identifier: IC 2011-04
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Metastatic Cancer; Palliative Care

Keywords

palliative care; cancer; quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• HADS (Hospital Anxiety and Depression Scale) anxiety and depression score

  one month

• QLQC-15Pal palliative quality of life score

  one month

• MB coping questionnaire score

  one month

• Two 5-point Likert scales on information needs and satisfaction with medical information

  one month

• Specific questionnaire on the Booklet-Question List (mode of use, satisfaction)

  one month

Study Arms (2)

Booklet-Question List (BQL) group

76 patients

Other: Booklet-Question List

control group

Conventional palliative management 76 patients

Interventions

Booklet-Question List OTHER

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

Booklet-Question List (BQL) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Cognitive disorders
• Documented psychiatric disorders or marked psychological fragility

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (5)

Léon Berard

Lyon, 69008, France

Location

Centre Alexis Vautrin

Nancy, 54519, France

Location

Institut Curie

Paris, 75005, France

Location

Hopital René Huguenin

Saint-Cloud, 92210, France

Location

Polyclinique de l'Ormeau

Tarbes, 65000, France

Location

Related Publications (1)

• Bouleuc C, Savignoni A, Chevrier M, Renault-Tessier E, Burnod A, Chvetzoff G, Poulain P, Copel L, Cottu P, Pierga JY, Bredart A, Dolbeault S. A Question Prompt List for Advanced Cancer Patients Promoting Advance Care Planning: A French Randomized Trial. J Pain Symptom Manage. 2021 Feb;61(2):331-341.e8. doi: 10.1016/j.jpainsymman.2020.07.026. Epub 2020 Jul 31.

  PMID: 32739563 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carole Bouleuc, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 3, 2016
• Study Start: May 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)