Medical Trainees in Oncology ProgramsNCT04557696
A Study to Implement and Evaluate REFLECT Communication Curriculum for Oncology Based Medical Graduate Students
A study testing REFLECT Curriculum in people with Medical Trainees in Oncology Programs, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to collect data from quarterly workshops (standardized patient simulations, reflective narratives, questionnaires, surveys, standardized patient and peer feedback, and participant critiques) of participants enrolled in oncology-based residencies and fellowships will be collected. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Trainees in Oncology Programs
- What is being tested?
- REFLECT Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2020to 24 Feb 2021
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects: Resident or Fellow enrolled in an oncology related training program (Radiation Oncology, Medical Oncology, Palliative Medicine and Hospice Care, Neurooncology).
- Location: Mayo Clinic Arizona.
- Interest: Willingness to participate.
Who cannot join
- Schedule does not permit to participation.
- Not enrolled in an oncology-based residency or fellowship at Mayo Clinic Arizona.
- Interest: Not willing to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation and Prospective Evaluation of the REFLECT Communication Curriculum for Oncology Based Medical Graduate Students
The purpose of this study is to collect data from quarterly workshops (standardized patient simulations, reflective narratives, questionnaires, surveys, standardized patient and peer feedback, and participant critiques) of participants enrolled in oncology-based residencies and fellowships will be collected. The information that is gathered from this study will be used to describe this population that participate in the workshop and see whether or not introduction of a communication curriculum alongside with the training program will improve communication, self-awareness, and interpersonal skills over time.
- Conditions
- Medical Trainees in Oncology Programs
- Being tested
- REFLECT Curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REFLECT CurriculumOther
Annual quarterly workshops will consist of guest lecturers, role playing, patient panels, coaching, knowledge assessments, Standardized Patient (SP) simulations and debriefing/feedback sessions.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Standard oncology curriculum for medical trainees in oncology programs. |
| Reflective Group | Experimental | Standard oncology curriculum with standardized patient simulation, in addition to the REFLECT Curriculum workshops for medical trainees in oncology programs. Receives: Other: REFLECT Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Intelligence
Change in emotional intelligence comparing baseline scores on the ESCI (Emotional and Social Competence Inventory) with scores on annual ESCI reassessments.
Measured: Baseline, annually through study completion approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start18 Aug 2020
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Why it stopped: Resident/fellow feedback indicated study factors made it difficult to participate and busy schedules did not accommodate to consent.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Trainees in Oncology ProgramsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Z. Vern-Gross, Mayo Clinic
- Investigators
- Tamara Vern-Gross, DO, FAAP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557696
- Sponsor's protocol ID
- 19-012188
- Status last verified
- Oct 2021
- First submitted
- 15 Sep 2020
- Last updated
- 25 Oct 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 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Prospective Evaluation of the REFLECT Communication Curriculum for Oncology Based Medical Graduate Students
- ClinicalTrials.gov ID
- NCT04557696
- Acronym / sponsor ID
- 19-012188
- Conditions
- Medical Trainees in Oncology Programs
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resident/fellow feedback indicated study factors made it difficult to participate and busy schedules did not accommodate to consent.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 22 Sep 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 purpose of this study is to collect data from quarterly workshops (standardized patient simulations, reflective narratives, questionnaires, surveys, standardized patient and peer feedback, and participant critiques) of participants enrolled in oncology-based residencies and fellowships will be collected. The information that is gathered from this study will be used to describe this population that participate in the workshop and see whether or not introduction of a communication curriculum alongside with the training program will improve communication, self-awareness, and interpersonal skills over time.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Standard oncology curriculum for medical trainees in oncology programs. |
| Reflective Group | Experimental | Other: REFLECT CurriculumStandard oncology curriculum with standardized patient simulation, in addition to the REFLECT Curriculum workshops for medical trainees in oncology programs. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects: Resident or Fellow enrolled in an oncology related training program (Radiation Oncology, Medical Oncology, Palliative Medicine and Hospice Care, Neurooncology).
- Location: Mayo Clinic Arizona.
- Interest: Willingness to participate.
Key exclusion criteria (3 listed)
- Schedule does not permit to participation.
- Not enrolled in an oncology-based residency or fellowship at Mayo Clinic Arizona.
- Interest: Not willing to participate.
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 |
|---|---|---|
| REFLECT CurriculumAnnual quarterly workshops will consist of guest lecturers, role playing, patient panels, coaching, knowledge assessments, Standardized Patient (SP) simulations and debriefing/feedback sessions. | Other | Reflective Group |
Primary outcome
Emotional Intelligence
Time frame: Baseline, annually through study completion approximately 10 years
Change in emotional intelligence comparing baseline scores on the ESCI (Emotional and Social Competence Inventory) with scores on annual ESCI reassessments.
Results and safety
The study was stopped early (reason given: Resident/fellow feedback indicated study factors made it difficult to participate and busy schedules did not accommodate to consent.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Tamara Vern-Gross, DO, FAAP principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REFLECT Curriculum in people with Medical Trainees in Oncology Programs, run by Mayo Clinic at 1 site in United States.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 25 Oct 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 United States. 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?
The study was stopped early (reason given: Resident/fellow feedback indicated study factors made it difficult to participate and busy schedules did not accommodate to consent.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Intelligence (time frame: Baseline, annually through study completion approximately 10 years). 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 25 Oct 2021.