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Completed

NCT Number: NCT02874001

French Validation of an Interview Guide to Cancer Announcement : 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

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Key information

Conditions

Cancer 18 Years and Over Neoplasms With Caregiver Support Time

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • without known psychiatric history

Treatment and study plan

Primary outcomes

  1. 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. 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).

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

  • Fondation de France
  • Ligue contre le cancer, France

Registry information

Official study title

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

Acronym: PO-BADO

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2016
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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