Sexual & Gender Minority Competency in Oncology

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Behavioral: SGM Competency Training Program

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

We will train cancer care personnel using our in-person SGM competency training.

Personnel must:

1. be a provider (physician, nurse, etc.), staff member, or administrator employed at a Wilmot care location;
2. be age 18 or older;
3. be able to understand English or American Sign Language (ASL, as training will be conducted in English with an ASL interpreter) and read English (as measures will be in English);
4. provide written informed consent.

Patients must:

1. have been diagnosed with any type of cancer;
2. be scheduled for an oncology-related visit (before, during, or after cancer treatment) at a Wilmot care location;
3. identify as a sexual and/or gender minority (SGM; e.g., preferring to partner with individuals of the same gender, identifying as a gender that differs from sex assigned at birth) or heterosexual and cisgender (H/C, for the comparison group; i.e., preferring to partner with individuals of the opposite gender and identifying as a gender that matches sex assigned at birth);
4. be age 18 or older;
5. be able to read and understand English (as measures and interviews will be in English);
6. provide written informed consent.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sexual & Gender Minority (SGM) Competence Training; Personnel will be trained using a validated, two-hour long SGM curriculum created by the Fenway Institute and tailored for Oncology.	Behavioral: SGM Competency Training Program; A validated, two-hour long SGM curriculum created by the Fenway Institute and tailored for oncology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Cross-sectional over 1 year

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Charles Kamen, PhD, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: UCC19177

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