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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04506710
Other study ID # RSCS-L0838
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date January 2022

Study information

Verified date July 2021
Source I.M. Sechenov First Moscow State Medical University
Contact Dmitry Enikeev, M.D., Ph.D.
Phone +79670897154
Email dvenikeev@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to identify the specific patterns of communication between doctors and oncological patients during medical consultations and develop recommendations to improve its effectiveness.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Histologically confirmed prostate cancer; 2. PSA up to 10 ng / ml; Gleason (3 + 3) = 6 (ISUP 1); the stage of the tumor T2a (low- risk according to the D'Amico scale); Exclusion Criteria: 1. Failure of the recording device; 2. Unsatisfactory audio quality.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Audio recording of the counseling conversation
The patient will have an audio-recorded counseling conversation. Audio recording will be carried out using a portable recorder ZOOM H2n. The audio recordings of the counseling conversations will be performed by the health workers selected to participate in the study.

Locations

Country Name City State
Russian Federation Institute for Urology and Reproductive Health, Sechenov University. Moscow

Sponsors (1)

Lead Sponsor Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification the communication techniques used by the doctor in the counseling conversation; 1 year
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