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NCT02874001 Clinical Trial

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

Cancer Clinical Trial

— PO-BADO  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02874001
Other study ID # IB-2013-PO BADO
Secondary ID
Status Completed
Phase N/A
First received August 8, 2016
Last updated August 16, 2016
Start date July 2015
Est. completion date August 2016

Study information
Verified date August 2016
Source Institut Bergonié
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study type Observational

Clinical 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- cancer

- having a caregiver support time

- Aged 18 years and over

Exclusion Criteria:

- without known psychiatric history

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Institut Bergonié Fondation de France, Ligue contre le cancer, France

Outcome
Type Measure Description Time frame Safety issue
Primary Validation of a questionnaire concerning psychosocial status traduction of questionnaire and validity évaluation (reliability and validity) baseline No
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