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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02874001
Acronym
PO-BADO
Enrollment
252
Registered
2016-08-22
Start date
2015-07-31
Completion date
2016-08-31
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

18 Years and Over, Cancer, With Caregiver Support Time

Keywords

psychology, caregiver support time

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

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.

Interventions

None listed

Sponsors

Fondation de France
CollaboratorOTHER
Ligue contre le cancer, France
CollaboratorOTHER
Institut Bergonié
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* without known psychiatric history

Design outcomes

Primary

MeasureTime frameDescription
Reliability of the Questionnaire in Terms of Internal Consistency2 weeks after diagnosisInternal 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 Reliability2 weeks after diagnosisQuestionnaires 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).

Participant flow

Participants by arm

ArmCount
Cancer Patients
Patientswere recruited from a Comprehensive Regional Cancer Centre in France
252
Total252

Baseline characteristics

CharacteristicCancer Patients
Age, Continuous57 years
STANDARD_DEVIATION 12.8
Race and Ethnicity Not Collected— Participants
Region of Enrollment
France
252 participants
Sex: Female, Male
Female
192 Participants
Sex: Female, Male
Male
60 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

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.

Time frame: 2 weeks after diagnosis

ArmMeasureValue (NUMBER)
Cancer PatientsReliability of the Questionnaire in Terms of Internal Consistency0.87 alpha coefficient
Primary

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).

Time frame: 2 weeks after diagnosis

Population: 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.

ArmMeasureValue (NUMBER)
Cancer PatientsReliability of the Questionnaire in Terms of Interrater Reliability0.71 correlation coefficient (range -1 to 1)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026