Sexual & Gender Minority Competency in Oncology

NCT04198090 | Completed DMC

• 1 other identifier: UCC19177
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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.

Behavioral: SGM Competency Training Program

Interventions

SGM Competency Training Program BEHAVIORAL

A validated, two-hour long SGM curriculum created by the Fenway Institute and tailored for oncology

Sexual & Gender Minority (SGM) Competence Training

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients must 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)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Charles Kamen, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-arm, open-label trial

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 13, 2019
• Study Start: February 17, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)