French Validation of an Interview Guide to Cancer Announcement : the Psycho Oncology Basic Documentation

NCT02874001 | Completed Results

• 1 other identifier: IB-2013-PO BADO
• Study Type: observational
• Target: 252
• Locations: 0 countries
• Sites: N/A

Brief Summary

Validation of the PO-BADO in its short and long versions that need a standardized validation process with the inclusion of 450 Patients

Conditions

Cancer; With Caregiver Support Time; 18 Years and Over

Keywords

psychology; caregiver support time

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  2 weeks after diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of cancer and having a caregiver support time

You may qualify if:

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

You may not qualify if:

• without known psychiatric history

Sponsors & Collaborators

• Institut Bergonié: lead
• Fondation de France: collaborator
• Ligue contre le cancer, France: collaborator

Related Publications (2)

• 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.

  PMID: 28711110 BACKGROUND

• 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.

  PMID: 24123416 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: S Mathoulin-Pélissier, Director of Clinical Trials Unit
• Organization: Institut Bergonié

s.mathoulin@bordeaux.unicancer.fr

+33556333333

Study Officials

• Stadelmaier Nena, PhD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 22, 2016
• Study Start: July 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 6, 2025
• Results First Posted: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share