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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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.

Jul 2015Aug 2016

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)

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 28711110
Stadelmaier 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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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

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

Results posted to the registry on 6 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cancer Patients	252	252

Primary outcome: Reliability of the Questionnaire in Terms of Internal Consistency

Time frame: 2 weeks after diagnosis. Number. Unit: alpha coefficient

Measure	Cancer Patients n = 252
Value	0.87

Primary outcome: Reliability of the Questionnaire in Terms of Interrater Reliability

Time frame: 2 weeks after diagnosis. Number (95% Confidence Interval). Unit: correlation coefficient (range -1 to 1)

Measure	Cancer Patients n = 40
Value	0.71 (0.43 to 0.95)

Population analysed: To estimate the interrater reliability (IRR), interviews of 40 patients were recorded and interpreted by four nurses. IRR was assessed using a two-way random, consistency, average-measures intraclass correlation coefficient to assess the degree that coders were consistent in their ratings for each patient.

Adverse events

Time frame: All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not collected. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cancer Patients	0 of 0	0 of 0	0

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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Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
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Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
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Gynaecological Cancers, Ovarian Cancer

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.