French Validation of an Interview Guide to Cancer Announcement : the Psycho Oncology Basic Documentation (PO-BADO)

September 16, 2025 updated by: Institut Bergonié

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

252

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis of cancer and having a caregiver support time

Description

Inclusion Criteria:

  • cancer
  • having a caregiver support time
  • Aged 18 years and over

Exclusion Criteria:

  • without known psychiatric history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks after diagnosis
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).
2 weeks after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Collaborators

Ligue contre le cancer, France
Fondation de France

Investigators

  • Principal Investigator: Stadelmaier Nena, PhD, Institut Bergonie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 8, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimated)

August 22, 2016

Study Record Updates

Last Update Posted (Estimated)

October 6, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB-2013-PO BADO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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