CancerPO-BADONCT02874001
French Validation of an Interview Guide to Cancer Announcement : the Psycho Oncology Basic Documentation
An observational study of Cancer and With Caregiver Support Time, run by Institut Bergonié.
Trial summary
Validation of the PO-BADO in its short and long versions that need a standardized validation process with the inclusion of 450 Patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, With Caregiver Support Time, 18 Years and Over
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Aug 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients with diagnosis of cancer and having a caregiver support time
Who may be able to join
- cancer
- having a caregiver support time
- Aged 18 years and over
Who cannot join
- without known psychiatric history
About this study
Official title: French Validation of an Interview Guide to the Announcement of Cancer: the Psycho Oncology Basic Documentation
Validation of the PO-BADO in its short and long versions that need a standardized validation process with the inclusion of 450 Patients
Read the detailed description
In the case of confirmation of the PO- Bado long version, that means for 240 patients a caregiver support time longest 15 minutes than usually suggested, since in 6 items of the Po- Bado usually explored in the caregiver support time, add 6 other additional items provided in the long version. This further time, can be considered as an additional contribution to the free expression.
For the 120 patients seen during the validation of the short version , there is no change in the duration of the caregiver support time.
- Conditions
- Cancer, With Caregiver Support Time, 18 Years and Over
- Keywords
- psychology, caregiver support time
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the Questionnaire in Terms of Internal Consistency
Internal consistency assessed using the Cronbach's alpha coefficient. Cronbach's alpha coefficient is the correlation between responses to a questionnaire.
Cronbach's alpha can take values between 0 and 1. The internal consistency of a test is greater when the correlation between items is high on average.
Measured: 2 weeks after diagnosis
Reliability of the Questionnaire in Terms of Interrater Reliability
Questionnaires were were recorded and interpreted by nurses. Inter-rater reliability assessed for each item and for the entire scale, based on the selection of four nurses who will independently rate the recorded content of interviews. The conclusions will be based on intraclass correlation coefficients (ICC).
Measured: 2 weeks after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startJul 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France, Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- Stadelmaier Nena, PhD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874001
- Sponsor's protocol ID
- IB-2013-PO BADO
- Acronym
- PO-BADO
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2016
- Last updated
- 6 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stadelmaier N, Gana K, Saada Y, Duguey-Cachey O, Quintard B. Psychometric Properties of the French Adaptation of the Basic Documentation for Psycho-Oncology (Po-Bado): A Distress Screening Tool. Behav Ther. 2017 Sep;48(5):596-602. doi: 10.1016/j.beth.2016.12.001. Epub 2016 Dec 13.
PubMed 28711110Stadelmaier N, Duguey-Cachet O, Saada Y, Quintard B. The Basic Documentation for Psycho-Oncology (PO-Bado): an innovative tool to combine screening for psychological distress and patient support at cancer diagnosis. Psychooncology. 2014 Mar;23(3):307-14. doi: 10.1002/pon.3421. Epub 2013 Oct 14.
PubMed 24123416
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Validation of an Interview Guide to the Announcement of Cancer: the Psycho Oncology Basic Documentation
- ClinicalTrials.gov ID
- NCT02874001
- Acronym / sponsor ID
- PO-BADO / IB-2013-PO BADO
- Conditions
- Cancer, With Caregiver Support Time, 18 Years and Over
- Keywords
- psychology, caregiver support time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Fondation de France, Ligue contre le cancer, France
- Study start
- Jul 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Posted 6 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Validation of the PO-BADO in its short and long versions that need a standardized validation process with the inclusion of 450 Patients
Detailed description
In the case of confirmation of the PO- Bado long version, that means for 240 patients a caregiver support time longest 15 minutes than usually suggested, since in 6 items of the Po- Bado usually explored in the caregiver support time, add 6 other additional items provided in the long version. This further time, can be considered as an additional contribution to the free expression.
For the 120 patients seen during the validation of the short version , there is no change in the duration of the caregiver support time.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of cancer and having a caregiver support time
Key inclusion criteria (3 listed)
- cancer
- having a caregiver support time
- Aged 18 years and over
Key exclusion criteria (1 listed)
- without known psychiatric history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability of the Questionnaire in Terms of Internal Consistency
Time frame: 2 weeks after diagnosis
Internal consistency assessed using the Cronbach's alpha coefficient. Cronbach's alpha coefficient is the correlation between responses to a questionnaire. Cronbach's alpha can take values between 0 and 1. The internal consistency of a test is greater when the correlation between items is high on average.
Reliability of the Questionnaire in Terms of Interrater Reliability
Time frame: 2 weeks after diagnosis
Questionnaires were were recorded and interpreted by nurses. Inter-rater reliability assessed for each item and for the entire scale, based on the selection of four nurses who will independently rate the recorded content of interviews. The conclusions will be based on intraclass correlation coefficients (ICC).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28711110Stadelmaier N, Gana K, Saada Y, Duguey-Cachey O, Quintard B. Psychometric Properties of the French Adaptation of the Basic Documentation for Psycho-Oncology (Po-Bado): A Distress Screening Tool. Behav Ther. 2017 Sep;48(5):596-602. doi: 10.1016/j.beth.2016.12.001. Epub 2016 Dec 13.
- Background: PubMed 24123416Stadelmaier N, Duguey-Cachet O, Saada Y, Quintard B. The Basic Documentation for Psycho-Oncology (PO-Bado): an innovative tool to combine screening for psychological distress and patient support at cancer diagnosis. Psychooncology. 2014 Mar;23(3):307-14. doi: 10.1002/pon.3421. Epub 2013 Oct 14.
- 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.
Stadelmaier Nena, PhD principal investigator
Institut Bergonié
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and With Caregiver Support Time, run by Institut Bergonié.
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 3 inclusion and 1 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 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 6 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reliability of the Questionnaire in Terms of Internal Consistency (time frame: 2 weeks after diagnosis). The study lists 2 primary outcomes in all. 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 NCT02874001, which also lists 2 linked publications.
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 6 Oct 2025.