Metastatic CancerQUEPALNCT02854293
Impact of a Booklet-Question List on Cancer Patients or Their Families Seeking Prognostic Information During a Palliative Care Consultation
An observational study of Metastatic Cancer and Palliative Care, run by Institut Curie at 5 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Palliative Care
- What is being tested?
- Booklet-Question List
- How many people
- 121 participants
- Where
- 5 sitesFrance
- Study dates
- May 2012to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient followed for metastatic cancer with or without specific treatment, with a limited life expectancy
Who may be able to join
- 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
Who cannot join
- Cognitive disorders
- Documented psychiatric disorders or marked psychological fragility
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Léon Berard
Lyon, 69008
Centre Alexis Vautrin
Nancy, 54519
Institut Curie
Paris, 75005
Hopital René Huguenin
Saint-Cloud, 92210
Polyclinique de l'Ormeau
Tarbes, 65000
About this study
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
- Being tested
- Booklet-Question List
- Keywords
- palliative care, cancer, quality of life
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Booklet-Question ListOther
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
| Study group | Role | What they receive |
|---|---|---|
| Booklet-Question List (BQL) group | 76 patients Receives: Other: Booklet-Question List | |
| control group | Conventional palliative management 76 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Secondary outcomes (5)
HADS (Hospital Anxiety and Depression Scale) anxiety and depression score
Measured: one month
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
Measured: one month
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
Measured: one month
Two 5-point Likert scales on information needs and satisfaction with medical information
Measured: one month
Specific questionnaire on the Booklet-Question List (mode of use, satisfaction)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startMay 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole Bouleuc, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854293
- Sponsor's protocol ID
- IC 2011-04
- Acronym
- QUEPAL
- Status last verified
- Nov 2025
- First submitted
- 27 Jul 2016
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32739563
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Booklet-Question List on Cancer Patients or Their Families Seeking Prognostic Information During a Palliative Care Consultation
- ClinicalTrials.gov ID
- NCT02854293
- Acronym / sponsor ID
- QUEPAL / IC 2011-04
- Conditions
- Metastatic Cancer, Palliative Care
- Keywords
- palliative care, cancer, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Booklet-Question List (BQL) group | – | Other: Booklet-Question List76 patients |
| control group | – | –Conventional palliative management 76 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient followed for metastatic cancer with or without specific treatment, with a limited life expectancy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive disorders
- Documented psychiatric disorders or marked psychological fragility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Booklet-Question ListBooklet-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 | Other | Booklet-Question List (BQL) group |
Primary outcome
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
5 secondary outcomes
HADS (Hospital Anxiety and Depression Scale) anxiety and depression score
Time frame: one month
QLQC-15Pal palliative quality of life score
Time frame: one month
MB coping questionnaire score
Time frame: one month
Two 5-point Likert scales on information needs and satisfaction with medical information
Time frame: one month
Specific questionnaire on the Booklet-Question List (mode of use, satisfaction)
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 32739563Bouleuc 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carole Bouleuc, MD principal investigator
Institut Curie
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer and Palliative Care, run by Institut Curie at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02854293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.