DeprescribingDEPALNCT06193083
DEprescribing: Perceptions of PAtients Living With Advanced Cancer
An observational study of Deprescribing and Palliative Care, run by Nantes University Hospital at 8 sites in France.
Trial summary
Polymedication in palliative oncology care is a real public health problem. This phenomenon has been shown to increase the risk of iatrogenesis, reduce patients' quality of life and increase healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deprescribing, Palliative Care, Oncology
- What is being tested?
- Semi-directed individual interviews, The self-administered questionnaires, rPATD and BMQ and The self-administered FCCHL (Functional, Communicative and Critical Health Literacy) / HLS14 (14-item health literacy scale)
- How many people
- 325 participants
- Where
- 8 sitesFrance
- Study dates
- 28 Feb 2024to 4 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: We'll be looking at major patients with "solid" cancer in a palliative situation (locally advanced or metastatic cancer, thus requiring palliative care as defined by the World Health Organization), who have at least one PIMs, followed up on an inpatient or outpatient basis, with a life expectancy estimated at less than 1 year by the doctor caring for the patient. To identify whether a patient has at least one PIMs, we will use the STOPPFrail 2 tool . This is a tool developed in geriatrics, validated for a population with an estimated life expectancy of less than 1 year, and which is not specific to oncology. Life expectancy of less than one year will be estimated by the question surprised by the doctor caring for the patient ("Would you be surprised if your patient died within a year?") . We will carry out a multicenter study in oncology and/or palliative care departments of hospitals located in western France.
Who may be able to join
- Patient over 18 years of age
- Locally advanced or metastatic solid cancer (i.e., palliative care as defined by the World Health Organization)
- Life expectancy estimated by the physician at inclusion of less than 1 year (use of surprise question to help clinician estimate life expectancy)
- Hospitalized or in consultation
- With at least one PIMs (identified using STOPPfrail 2)
- Patient not having expressed opposition to participating in the study after receiving information from the physician.
- For qualitative study patients :
- Patients who have signed an authorization for the recording of their voice during the semi-structured interview for the purpose of written transcription.
Who cannot join
- Minor
- Major under guardianship, protected person
- Patient unable to speak or write French
- Patient with impaired judgment, cognitive or sensory impairment that prevents him/her from receiving informed information, answering questionnaires or participating in a study interview.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
CHD Vendée
La Roche-sur-Yon, 85000
Caroline HENNION, PH, 0251446161, caroline.hennion@ght85.fr
- Not yet recruiting
Hospices Civils de Lyon
Lyon
Guillaume ECONOMOS, 04 78 86 10 99, guillaume.economos@chu-lyon.fr
Guillaume ECONOMOS, MD
- Recruiting
CHU de Nantes
Nantes, 44093
Adrien EVIN, MCU-PH, +33253482736, adrien.evin@chu-nantes.fr
Adrien EVIN, MCU-PH
- Not yet recruiting
USP - Maison de Nicodème
Nantes
Benjamin CHARTIER, 02 28 24 24 65, benjamin.chartier@hstv.fr
Benjamin CHARTIER, MD
- Not yet recruiting
Hôpital Institut CURIE
Paris, 75005
Stéphanie TRAGER, +33156245500, stephanie.trager@curie.fr
Stéphanie Träger
- Not yet recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44800
Véronique BARBAROT, 0240679900, veronique.barbarot@ico.unicancer.fr
BARBAROT Véronique
- Not yet recruiting
CH ST Nazaire
Saint-Nazaire, 44600
Virginie DESSUS-CHEVREL, 0272278000, v.dessus-chevrel@ch-saintnazaire.fr
Virginie DESSUS-CHEVREL, PH
- Not yet recruiting
CHRU Tours
Tours
François CHAUMIER, 02 47 47 70 30 ext. +33, francois.chaumier@univ-tours.fr
About this study
Official title: DEprescribing: Perceptions of PAtients Living With Advanced Cancer. A Multicentre, Prospective Mixed Observational Study
Polymedication in palliative oncology care is a real public health problem. This phenomenon has been shown to increase the risk of iatrogenesis, reduce patients' quality of life and increase healthcare costs. For many years, health policies have been developed in geriatrics to reduce polymedication through deprescription tools.
Recently, palliative care initiatives have been introduced, but without having studied the potential specificities of this population (younger, with a different care dynamic and life trajectory). It is important to better understand this population's perceptions of deprescribing in order to adapt tools/actions to make these approaches more efficient.
Read more
The primary aim of this study is to investigate patients' perceptions of deprescribing in palliative cancer care, and the secondary aim is to investigate factors that may influence patients' attitudes and beliefs about deprescribing. At the same time, we will study the psychometric properties of the rPATD (Revised Patients' Attitudes Towards Deprescribing) in this population (a standardized questionnaire validated in geriatric medicine to assess patients' perceptions of deprescription).An ancillary study will be carried out to investigate the link between patients' health literacy and their perception of deprescribing (health literacy is defined as the ability to acquire, understand and use information in ways that promote and maintain good health).
To meet our objectives, we will conduct a 3-year national, prospective, observational, multicenter study with an exploratory sequential mixed design. The study will comprise an initial qualitative phase. Semi-directed individual interviews using a descriptive approach will be carried out (around 25 patients, over an 8-month period). Following analysis of the qualitative data, we will then carry out a quantitative study to determine the distribution of the different profiles within this population and the factors influencing the perception of deprescription. The self-administered questionnaires, rPATD and BMQ (medication beliefs questionnaire), potentially supplemented by other items following analysis of the qualitative data, will be administered to 300 patients (over a 12-month period).The ancillary study will be carried out during this second phase, using a validated self-questionnaire to assess patients' level of literacy.
Thanks to the different results, we will improve our knowledge of the perception of deprescription in palliative oncology care, in order to develop approaches adapted to the specificities of our population to reduce polymedication and thus improve the quality of life of our patients and reduce the risks of iatrogenia.
- Conditions
- Deprescribing, Palliative Care, Oncology
- Being tested
- Semi-directed individual interviews, The self-administered questionnaires, rPATD and BMQ, The self-administered FCCHL (Functional, Communicative and Critical Health Literacy) / HLS14 (14-item health literacy scale)
- Keywords
- Deprescribing, Palliative care, Oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-directed individual interviewsOther
Individual semi-structured interviews (descriptive approach methodology with reflexive thematic analysis)
The self-administered questionnaires, rPATD and BMQOther
rPATD: The rPATD is a questionnaire validated and adapted in French to assess patients' perceptions of their treatments and deprescribing.
This self-administered questionnaire consists of 22 questions rated on a 5-point Likert scale (scale from 1 to 5, at 1 the patient completely agrees with the questionnaire's proposal, at 5 the patient strongly disagrees with the questionnaire's proposal). Following the analysis of Phase 1 "Qualitative" of the protocol, three additional questions
BMQ French version of the BMQ self-questionnaire, which studies patients' perceptions of medication .
The Beliefs about Medicine Questionnaire (BMQ) is an 18-item self-administered questionnaire designed to explore patient perceptions of medicine. It has been validated in French and is free to use.
It comprises 10 items relating to specific beliefs about prescribed treatments:
A 5-point Likert-type scale was used for each item. The higher the sum of the scores obtained, the stronger the subject's belief.
The self-administered FCCHL (Functional, Communicative and Critical Health Literacy) / HLS14 (14-item health literacy scale)Other
FCCHL (Functional, Communicative and Critical Health Literacy)/HLS14 (14-item health literacy scale) (https://reflis.fr/wp-content/uploads/2020/07/FCCHL-HLS14-Questionnaire-Litteratie-sante.pdf )
Validated French-language self-administered questionnaire and consisting of14 items with a 5-point Likert scale for assessing health literacy :
Functional literacy: basic reading and writing skills sufficient to function effectively in everyday situations Communicative or interactive literacy: more advanced cognitive and literacy skills that, combined with social skills, can be used to actively participate in everyday activities, extract information and meanings from different forms of communication, and apply new information to changing circumstances Critical literacy: more advanced cognitive skills which, combined with social skills, can be applied to the critical analysis of information and the use of that information to exercise greater control over life events and situations
| Study group | Role | What they receive |
|---|---|---|
| Qualitative study | The study will comprise an initial qualitative phase. Semi-directed individual interviews using a descriptive approach will be carried out (around 25 patients, over an 8-month period). Receives: Other: Semi-directed individual interviews | |
| Quantitative study | Following analysis of the qualitative data, we will then carry out a quantitative study to determine the distribution of the different profiles within this population and the factors influencing the perception of deprescription. The self-administered questionnaires, rPATD and BMQ (medication beliefs questionnaire), potentially supplemented by other items following analysis of the qualitative data, will be administered to 300 patients (over a 12-month period).
The ancillary study will be carried out during this second phase, using a validated self-questionnaire to assess patients' level of literacy. Receives: Other: The self-administered questionnaires, rPATD and BMQ; Other: The self-administered FCCHL (Functional, Communicative and Critical Health Literacy) / HLS14 (14-item health literacy scale) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study patients' perceptions of deprescribing in palliative cancer care.
To describe, understand and explain patients' attitudes and beliefs concerning deprescribing by means of individual semi-structured interviews (descriptive approach methodology with reflexive thematic analysis) and secondly using the rPATD questionnaire (questionnaire for assessing patients' perceptions of their treatments and deprescribing), which can be adapted following analysis of qualitative data.
rPATD: The rPATD is a questionnaire validated and adapted in French to assess patients' perceptions of their treatments and deprescribing.
This self-administered questionnaire consists of 22 questions rated on a 5-point Likert scale
Measured: at study inclusion
Secondary outcomes (2)
To investigate factors that may influence patients' attitudes and beliefs regarding de-prescribing.
Influence of gender, age, level of education, type of cancer, number of metastatic sites, Performans status score, presence of systemic cancer treatment (chemotherapy, targeted therapy, immunotherapy, hormonal therapy, etc.), follow-up by a palliative care team, and other factors. ), follow-up by a palliative care team, patient's place of care, persons in charge of treatment, number of medications, number of potentially inappropriate medications (PIMs), prognosis assessed by the referring physician, patient's level of education and beliefs about treatments in general (BMQ questionnaire) on scores from the rPATD questionnaire.
Measured: at study inclusion
To evaluate the psychometric properties of the rPATD in this population.
Description of rPATD validation data in our population: validation of questionnaire structure, measurement of score reliability, concurrent validation with the BMQ questionnaire.
BMQ French version of the BMQ self-questionnaire, which studies patients' perceptions of medication .
A 5-point Likert-type scale was used for each item. The higher the sum of the scores obtained, the stronger the subject's belief.
Measured: at study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start28 Feb 2024
- Primary completion28 Feb 2025
- Study completion4 Jun 2027 (estimated)
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 DeprescribingStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France, Nantes University
- Responsible party
- Sponsor
- Investigators
- Adrien EVIN, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193083
- Sponsor's protocol ID
- RC23_0563
- Acronym
- DEPAL
- Status last verified
- Sep 2026
- First submitted
- 21 Dec 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evin A, Bourdon M, Nizet P, Hardouin JB, Victorri-Vigneau C, Huon JF. DEprescribing: Perceptions of PAtients living with advanced cancer. A multicentre, prospective mixed observational study protocol. PLoS One. 2024 Aug 20;19(8):e0305737. doi: 10.1371/journal.pone.0305737. eCollection 2024.
PubMed 39163415
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEprescribing: Perceptions of PAtients Living With Advanced Cancer. A Multicentre, Prospective Mixed Observational Study
- ClinicalTrials.gov ID
- NCT06193083
- Acronym / sponsor ID
- DEPAL / RC23_0563
- Conditions
- Deprescribing, Palliative Care, Oncology
- Keywords
- Deprescribing, Palliative care, Oncology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Fondation de France, Nantes University
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 4 Jun 2027 (estimated)
- First posted
- 5 Jan 2024 (actual)
- 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.
Polymedication in palliative oncology care is a real public health problem. This phenomenon has been shown to increase the risk of iatrogenesis, reduce patients' quality of life and increase healthcare costs. For many years, health policies have been developed in geriatrics to reduce polymedication through deprescription tools.
Recently, palliative care initiatives have been introduced, but without having studied the potential specificities of this population (younger, with a different care dynamic and life trajectory). It is important to better understand this population's perceptions of deprescribing in order to adapt tools/actions to make these approaches more efficient.
The primary aim of this study is to investigate patients' perceptions of deprescribing in palliative cancer care, and the secondary aim is to investigate factors that may influence patients' attitudes and beliefs about deprescribing. At the same time, we will study the psychometric properties of the rPATD (Revised Patients' Attitudes Towards Deprescribing) in this population (a standardized questionnaire validated in geriatric medicine to assess patients' perceptions of deprescription).An ancillary study will be carried out to investigate the link between patients' health literacy and their perception of deprescribing (health literacy is defined as the ability to acquire, understand and use information in ways that promote and maintain good health).
To meet our objectives, we will conduct a 3-year national, prospective, observational, multicenter study with an exploratory sequential mixed design. The study will comprise an initial qualitative phase. Semi-directed individual interviews using a descriptive approach will be carried out (around 25 patients, over an 8-month period). Following analysis of the qualitative data, we will then carry out a quantitative study to determine the distribution of the different profiles within this population and the factors influencing the perception of deprescription. The self-administered questionnaires, rPATD and BMQ (medication beliefs questionnaire), potentially supplemented by other items following analysis of the qualitative data, will be administered to 300 patients (over a 12-month period).The ancillary study will be carried out during this second phase, using a validated self-questionnaire to assess patients' level of literacy.
Thanks to the different results, we will improve our knowledge of the perception of deprescription in palliative oncology care, in order to develop approaches adapted to the specificities of our population to reduce polymedication and thus improve the quality of life of our patients and reduce the risks of iatrogenia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qualitative study | – | Other: Semi-directed individual interviewsThe study will comprise an initial qualitative phase. Semi-directed individual interviews using a descriptive approach will be carried out (around 25 patients, over an 8-month period). |
| Quantitative study | – | Other: The self-administered questionnaires, rPATD and BMQ, Other: The self-administered FCCHL (Functional, Communicative and Critical Health Literacy) / HLS14 (14-item health literacy scale)Following analysis of the qualitative data, we will then carry out a quantitative study to determine the distribution of the different profiles within this population and the factors influencing the perception of deprescription. The self-administered questionnaires, rPATD and BMQ (medication beliefs questionnaire), potentially supplemented by other items following analysis of the qualitative data, will be administered to 300 patients (over a 12-month period). The ancillary study will be carried out during this second phase, using a validated self-questionnaire to assess patients' level of literacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We'll be looking at major patients with "solid" cancer in a palliative situation (locally advanced or metastatic cancer, thus requiring palliative care as defined by the World Health Organization), who have at least one PIMs, followed up on an inpatient or outpatient basis, with a life expectancy estimated at less than 1 year by the doctor caring for the patient. To identify whether a patient has at least one PIMs, we will use the STOPPFrail 2 tool . This is a tool developed in geriatrics, validated for a population with an estimated life expectancy of less than 1 year, and which is not specific to oncology. Life expectancy of less than one year will be estimated by the question surprised by the doctor caring for the patient ("Would you be surprised if your patient died within a year?") . We will carry out a multicenter study in oncology and/or palliative care departments of hospitals located in western France.
Key inclusion criteria (8 listed)
- Patient over 18 years of age
- Locally advanced or metastatic solid cancer (i.e., palliative care as defined by the World Health Organization)
- Life expectancy estimated by the physician at inclusion of less than 1 year (use of surprise question to help clinician estimate life expectancy)
- Hospitalized or in consultation
- With at least one PIMs (identified using STOPPfrail 2)
Key exclusion criteria (4 listed)
- Minor
- Major under guardianship, protected person
- Patient unable to speak or write French
- Patient with impaired judgment, cognitive or sensory impairment that prevents him/her from receiving informed information, answering questionnaires or participating in a study interview.
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 |
|---|---|---|
| Semi-directed individual interviewsIndividual semi-structured interviews (descriptive approach methodology with reflexive thematic analysis) | Other | Qualitative study |
| The self-administered questionnaires, rPATD and BMQrPATD: The rPATD is a questionnaire validated and adapted in French to assess patients' perceptions of their treatments and deprescribing. This self-administered questionnaire consists of 22 questions rated on a 5-point Likert scale (scale from 1 to 5, at 1 the patient completely agrees with the questionnaire's proposal, at 5 the patient strongly disagrees with the questionnaire's proposal). Following the analysis of Phase 1 "Qualitative" of the protocol, three additional questions BMQ French version of the BMQ self-questionnaire, which studies patients' perceptions of medication . The Beliefs about Medicine Questionnaire (BMQ) is an 18-item self-administered questionnaire designed to explore patient perceptions of medicine. It has been validated in French and is free to use. It comprises 10 items relating to specific beliefs about prescribed treatments: A 5-point Likert-type scale was used for each item. The higher the sum of the scores obtained, the stronger the subject's belief. | Other | Quantitative study |
| The self-administered FCCHL (Functional, Communicative and Critical Health Literacy) / HLS14 (14-item health literacy scale)FCCHL (Functional, Communicative and Critical Health Literacy)/HLS14 (14-item health literacy scale) (https://reflis.fr/wp-content/uploads/2020/07/FCCHL-HLS14-Questionnaire-Litteratie-sante.pdf ) Validated French-language self-administered questionnaire and consisting of14 items with a 5-point Likert scale for assessing health literacy : Functional literacy: basic reading and writing skills sufficient to function effectively in everyday situations Communicative or interactive literacy: more advanced cognitive and literacy skills that, combined with social skills, can be used to actively participate in everyday activities, extract information and meanings from different forms of communication, and apply new information to changing circumstances Critical literacy: more advanced cognitive skills which, combined with social skills, can be applied to the critical analysis of information and the use of that information to exercise greater control over life events and situations | Other | Quantitative study |
Primary outcome
To study patients' perceptions of deprescribing in palliative cancer care.
Time frame: at study inclusion
To describe, understand and explain patients' attitudes and beliefs concerning deprescribing by means of individual semi-structured interviews (descriptive approach methodology with reflexive thematic analysis) and secondly using the rPATD questionnaire (questionnaire for assessing patients' perceptions of their treatments and deprescribing), which can be adapted following analysis of qualitative data. rPATD: The rPATD is a questionnaire validated and adapted in French to assess patients' perceptions of their treatments and deprescribing. This self-administered questionnaire consists of 22 questions rated on a 5-point Likert scale
2 secondary outcomes
To investigate factors that may influence patients' attitudes and beliefs regarding de-prescribing.
Time frame: at study inclusion
To evaluate the psychometric properties of the rPATD in this population.
Time frame: at study inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 39163415Evin A, Bourdon M, Nizet P, Hardouin JB, Victorri-Vigneau C, Huon JF. DEprescribing: Perceptions of PAtients living with advanced cancer. A multicentre, prospective mixed observational study protocol. PLoS One. 2024 Aug 20;19(8):e0305737. doi: 10.1371/journal.pone.0305737. eCollection 2024.
- 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.
Adrien EVIN principal investigator
Nantes University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deprescribing and Palliative Care, run by Nantes University Hospital at 8 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrien EVIN, MCU-PH (+33253482736, Adrien.EVIN@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study patients' perceptions of deprescribing in palliative cancer care. (time frame: at study inclusion). 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 NCT06193083, 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 25 Sep 2026.