Prostate CancerNCT04506710
Improvement of Communicational Skills Between Health Workers and Oncological Patients During Medical Consultative Conversations
An observational study of Prostate Cancer, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Audio recording of the counseling conversation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 1 Aug 2019to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Males with low-risk prostate cancer
Who may be able to join
- 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);
Who cannot join
- Failure of the recording device;
- Unsatisfactory audio quality.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, 119991
Dmitry Enikeev, M.D., Ph.D, +7 9670897154, enikeev-dv@1msmu.ru
Mark Taratkin, MD, +7 9670897154, marktaratkin@gmail.com
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- Audio recording of the counseling conversation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio recording of the counseling conversationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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)) Receives: Behavioral: Audio recording of the counseling conversation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification the communication techniques used by the doctor in the counseling conversation;
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Aug 2019
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
- Investigators
- Fedorovskaya Viktorya, Study director, Institute of Linguistics and Intercultural Communication
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506710
- Sponsor's protocol ID
- RSCS-L0838
- Status last verified
- Jul 2021
- First submitted
- 6 Aug 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ways to Improve the Efficiency of Communication Between Health Workers and Oncological Patients During Medical Consultative Conversations: an Observational Clinical Study
- ClinicalTrials.gov ID
- NCT04506710
- Acronym / sponsor ID
- RSCS-L0838
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with low-risk prostate cancer | – | Behavioral: Audio recording of the counseling conversationHistologically 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)) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males with low-risk prostate cancer
Key inclusion criteria (2 listed)
- 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);
Key exclusion criteria (2 listed)
- Failure of the recording device;
- Unsatisfactory audio quality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio recording of the counseling conversationThe 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. | Behavioural | Patients with low-risk prostate cancer |
Primary outcome
Identification the communication techniques used by the doctor in the counseling conversation;
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fedorovskaya Viktorya study director
Institute of Linguistics and Intercultural Communication
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Enikeev, M.D., Ph.D. (+79670897154, dvenikeev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification the communication techniques used by the doctor in the counseling conversation; (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.