Trial Outcomes & Findings for French Validation of an Interview Guide to Cancer Announcement : the Psycho Oncology Basic Documentation (NCT NCT02874001)

NCT ID: NCT02874001

Last Updated: 2025-10-06

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 252 participants
• Primary outcome timeframe: 2 weeks after diagnosis
• Results posted on: 2025-10-06

Participant Flow

Participant milestones

Measure	Cancer Patients Patientswere recruited from a Comprehensive Regional Cancer Centre in France
Overall Study STARTED	252
Overall Study COMPLETED	252
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Cancer Patients n=252 Participants Patientswere recruited from a Comprehensive Regional Cancer Centre in France
Age, Continuous	57 years STANDARD_DEVIATION 12.8 • n=252 Participants
Sex: Female, Male Female	192 Participants n=252 Participants
Sex: Female, Male Male	60 Participants n=252 Participants
Region of Enrollment France	252 participants n=252 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Cancer Patients n=252 Participants Patientswere recruited from a Comprehensive Regional Cancer Centre in France
Reliability of the Questionnaire in Terms of Internal Consistency	0.87 alpha coefficient

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Cancer Patients n=40 Participants Patientswere recruited from a Comprehensive Regional Cancer Centre in France
Reliability of the Questionnaire in Terms of Interrater Reliability	0.71 correlation coefficient (range -1 to 1) Interval 0.43 to 0.95

Adverse Events

Cancer Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

S Mathoulin-Pélissier, Director of Clinical Trials Unit

Institut Bergonié

Phone: +33556333333

Email: s.mathoulin@bordeaux.unicancer.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place