- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04506710
Improvement of Communicational Skills Between Health Workers and Oncological Patients During Medical Consultative Conversations
July 21, 2021 updated by: Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
Ways to Improve the Efficiency of Communication Between Health Workers and Oncological Patients During Medical Consultative Conversations: an Observational Clinical Study
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mark Taratkin, M.D.
- Phone Number: +79670897154
- Email: marktaratkin@gmail.com
Study Locations
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-
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Moscow, Russian Federation, 119991
- Recruiting
- Institute for Urology and Reproductive Health, Sechenov University.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Males with low-risk prostate cancer
Description
Inclusion Criteria:
- Histologically confirmed prostate cancer;
- 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:
- Failure of the recording device;
- Unsatisfactory audio quality.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with low-risk prostate cancer
Histologically confirmed low-risk prostate cancer (PSA up to 10 ng / ml; Gleason (3 + 3) = 6 (ISUP 1); tumor stage T2a (low- risk according to the D'Amico scale))
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Identification the communication techniques used by the doctor in the counseling conversation;
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Fedorovskaya Viktorya, Institute of Linguistics and Intercultural Communication
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
January 1, 2022
Study Registration Dates
First Submitted
August 6, 2020
First Submitted That Met QC Criteria
August 6, 2020
First Posted (Actual)
August 10, 2020
Study Record Updates
Last Update Posted (Actual)
July 28, 2021
Last Update Submitted That Met QC Criteria
July 21, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSCS-L0838
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.