NeoplasmsNCT04198090
Sexual & Gender Minority Competency in Oncology
A study testing SGM Competency Training Program in people with Neoplasms, run by University of Rochester at 1 site in United States.
Trial summary
This study is a single-arm, open-label trial of a sexual and gender minority (SGM) competence training program at Wilmot Cancer Institute (Wilmot) and its regional care locations (e.g., Wilmot Medical Oncology, Wilmot Radiation Oncology, Gynecological Oncology, Highland Hospital, Pluta Cancer Center). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasms
- What is being tested?
- SGM Competency Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2020to 31 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Sexual & Gender Minority Competency in Oncology Practice
This study is a single-arm, open-label trial of a sexual and gender minority (SGM) competence training program at Wilmot Cancer Institute (Wilmot) and its regional care locations (e.g., Wilmot Medical Oncology, Wilmot Radiation Oncology, Gynecological Oncology, Highland Hospital, Pluta Cancer Center). Results will be descriptive in nature and will be used to inform a R01 grant application.
The investigators will train Wilmot personnel (physicians, nurses, other providers, staff, and administrators) at each care location using a validated, two-hour long SGM curriculum created by the Fenway Institute and tailored for oncology. The investigators will collect data from all personnel on knowledge and attitudes about SGM patients before and after the training. After the training is complete, the investigators will recruit 5 SGM patients and 5 heterosexual/cisgender (H/C) patients from each care location to provide data on their satisfaction with care, outcomes, and experiences.
Read the detailed description
This study is a single-arm, open-label trial of a sexual and gender minority (SGM) competence training program at Wilmot Cancer Institute (Wilmot) and its regional care locations (e.g., Wilmot Medical Oncology, Wilmot Radiation Oncology, Gynecological Oncology, Highland Hospital, Pluta Cancer Center). Results will be descriptive in nature and will be used to inform a R01 grant application.
The investigators will train Wilmot personnel (physicians, nurses, other providers, staff, and administrators) at each care location using a validated, two-hour long SGM curriculum created by the Fenway Institute and tailored for oncology. The investigators will collect data from all personnel on knowledge and attitudes about SGM patients before and after the training. Because competent communication may manifest in subtle, automatic, non-verbal processes, the investigators will also video record and analyze clinical interactions between SGM patients, heterosexual/cisgender (H/C) patients, and their oncologists. This study has four aims:
Aim 1: To test whether a SGM competence intervention improves knowledge and attitudes among Wilmot personnel (on a 8 item questionnaire) from pre- to post-training.
Aim 2: To explore patient satisfaction (on the Hospital Consumer Assessment of Healthcare Providers and Systems, HCAHPS) in Wilmot care locations both before and after our SGM competence intervention.
Aim 3: To explore patient stress (psychological distress on the Brief Symptom Inventory, anticipatory stigma on the Expectations of Rejection Scale, and experiences of discrimination on the Everyday Discrimination Scale) before and after a SGM competence intervention.
Aim 4: To explore non-verbal synchrony by conducting Motion Energy Analysis (MEA) in video recordings of clinical discussions between SGM cancer patients and their oncologists vs. H/C cancer patients and their oncologists.
- Conditions
- Neoplasms
- Being tested
- SGM Competency Training Program
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGM Competency Training ProgramBehavioural
A validated, two-hour long SGM curriculum created by the Fenway Institute and tailored for oncology
| Study group | Role | What they receive |
|---|---|---|
| Sexual & Gender Minority (SGM) Competence Training | Other | Personnel will be trained using a validated, two-hour long SGM curriculum created by the Fenway Institute and tailored for Oncology. Receives: Behavioral: SGM Competency Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing SGM competence
Personnel outcomes pre and post training will be measured using an 8-item tool created by the Fenway Institute. This tool measures knowledge about disparities and needs of SGM cancer patients, as well as attitudes about treating SGM patients. Items are rated on a 4-point scale and summed to create an overall score ranging from 0 to 32; higher scores signify better knowledge and attitudes.
Measured: Pre- to post-training
Exploring Patient Satisfaction
Patient satisfaction with care will be measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS, 9 items).82 HCAHPS is a national, standard, publicly reported survey of patients' perspectives on healthcare. Items measure perceived physician understanding of patient goals and communication about healthcare choices, as well as an overall rating of care received. Items can be averaged into a composite score ranging from 0 to 5, with 4-5 indicating high satisfaction.
Measured: Cross-sectional over 1 year
Exploring Patient Stress
Psychological distress will be measured with the Brief Symptom Inventory (BSI-18).83,84 The BSI is an 18-item measure with three 6-item somatization, anxiety, and depression scales, as well as a total score (our outcome). The BSI has been well-validated in multiple studies as a measure of psychological distress in patients with various medical illnesses,85 including cancer.86 The BSI served as a convergent validity measure in developing the Distress Thermometer now recommended by the National Comprehensive Cancer Network for screening cancer patients for distress.87 Items are rated on a 4-point scale, summed, and the total score is converted to a standardized T-score; higher scores indicate higher distress.
Measured: Cross-sectional over 1 year
Exploring perspectives of SGM patients
We will video record clinical interactions between 5 SGM cancer patients and their oncologists, as well as 5 H/C cancer patients and their oncologists. All analyses will be performed with Motion Energy Analysis (MEA) to obtain an overall estimate of nonverbal synchrony.
Measured: Cross-sectional over 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start17 Feb 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open-label trial
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Kamen, University of Rochester
- Investigators
- Charles Kamen, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198090
- Sponsor's protocol ID
- UCC19177
- Status last verified
- Jan 2022
- First submitted
- 10 Dec 2019
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sexual & Gender Minority Competency in Oncology Practice
- ClinicalTrials.gov ID
- NCT04198090
- Acronym / sponsor ID
- UCC19177
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Dec 2019 (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.
This study is a single-arm, open-label trial of a sexual and gender minority (SGM) competence training program at Wilmot Cancer Institute (Wilmot) and its regional care locations (e.g., Wilmot Medical Oncology, Wilmot Radiation Oncology, Gynecological Oncology, Highland Hospital, Pluta Cancer Center). Results will be descriptive in nature and will be used to inform a R01 grant application.
The investigators will train Wilmot personnel (physicians, nurses, other providers, staff, and administrators) at each care location using a validated, two-hour long SGM curriculum created by the Fenway Institute and tailored for oncology. The investigators will collect data from all personnel on knowledge and attitudes about SGM patients before and after the training. After the training is complete, the investigators will recruit 5 SGM patients and 5 heterosexual/cisgender (H/C) patients from each care location to provide data on their satisfaction with care, outcomes, and experiences.
Detailed description
This study is a single-arm, open-label trial of a sexual and gender minority (SGM) competence training program at Wilmot Cancer Institute (Wilmot) and its regional care locations (e.g., Wilmot Medical Oncology, Wilmot Radiation Oncology, Gynecological Oncology, Highland Hospital, Pluta Cancer Center). Results will be descriptive in nature and will be used to inform a R01 grant application.
The investigators will train Wilmot personnel (physicians, nurses, other providers, staff, and administrators) at each care location using a validated, two-hour long SGM curriculum created by the Fenway Institute and tailored for oncology. The investigators will collect data from all personnel on knowledge and attitudes about SGM patients before and after the training. Because competent communication may manifest in subtle, automatic, non-verbal processes, the investigators will also video record and analyze clinical interactions between SGM patients, heterosexual/cisgender (H/C) patients, and their oncologists. This study has four aims:
Aim 1: To test whether a SGM competence intervention improves knowledge and attitudes among Wilmot personnel (on a 8 item questionnaire) from pre- to post-training.
Aim 2: To explore patient satisfaction (on the Hospital Consumer Assessment of Healthcare Providers and Systems, HCAHPS) in Wilmot care locations both before and after our SGM competence intervention.
Aim 3: To explore patient stress (psychological distress on the Brief Symptom Inventory, anticipatory stigma on the Expectations of Rejection Scale, and experiences of discrimination on the Everyday Discrimination Scale) before and after a SGM competence intervention.
Aim 4: To explore non-verbal synchrony by conducting Motion Energy Analysis (MEA) in video recordings of clinical discussions between SGM cancer patients and their oncologists vs. H/C cancer patients and their oncologists.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open-label trial
| Arm | Type | Receives |
|---|---|---|
| Sexual & Gender Minority (SGM) Competence Training | Other | Behavioral: SGM Competency Training ProgramPersonnel will be trained using a validated, two-hour long SGM curriculum created by the Fenway Institute and tailored for Oncology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| SGM Competency Training ProgramA validated, two-hour long SGM curriculum created by the Fenway Institute and tailored for oncology | Behavioural | Sexual & Gender Minority (SGM) Competence Training |
Primary outcome
Testing SGM competence
Time frame: Pre- to post-training
Personnel outcomes pre and post training will be measured using an 8-item tool created by the Fenway Institute. This tool measures knowledge about disparities and needs of SGM cancer patients, as well as attitudes about treating SGM patients. Items are rated on a 4-point scale and summed to create an overall score ranging from 0 to 32; higher scores signify better knowledge and attitudes.
Exploring Patient Satisfaction
Time frame: Cross-sectional over 1 year
Patient satisfaction with care will be measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS, 9 items).82 HCAHPS is a national, standard, publicly reported survey of patients' perspectives on healthcare. Items measure perceived physician understanding of patient goals and communication about healthcare choices, as well as an overall rating of care received. Items can be averaged into a composite score ranging from 0 to 5, with 4-5 indicating high satisfaction.
Exploring Patient Stress
Time frame: Cross-sectional over 1 year
Psychological distress will be measured with the Brief Symptom Inventory (BSI-18).83,84 The BSI is an 18-item measure with three 6-item somatization, anxiety, and depression scales, as well as a total score (our outcome). The BSI has been well-validated in multiple studies as a measure of psychological distress in patients with various medical illnesses,85 including cancer.86 The BSI served as a convergent validity measure in developing the Distress Thermometer now recommended by the National Comprehensive Cancer Network for screening cancer patients for distress.87 Items are rated on a 4-point scale, summed, and the total score is converted to a standardized T-score; higher scores indicate higher distress.
Exploring perspectives of SGM patients
Time frame: Cross-sectional over 1 year
We will video record clinical interactions between 5 SGM cancer patients and their oncologists, as well as 5 H/C cancer patients and their oncologists. All analyses will be performed with Motion Energy Analysis (MEA) to obtain an overall estimate of nonverbal synchrony.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- 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.
Charles Kamen, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SGM Competency Training Program in people with Neoplasms, run by University of Rochester 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 0 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jan 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Testing SGM competence (time frame: Pre- to post-training). The study lists 4 primary outcomes in all. 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 14 Jan 2022.