Clinical trial NCT04198090: Sexual & Gender Minority Competency in Oncology
Official title: Efficacy of Sexual & Gender Minority Competency in Oncology Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, open-label trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Testing SGM competence
timeFrame: Pre- to post-training
measure: Exploring Patient Satisfaction
timeFrame: Cross-sectional over 1 year
measure: Exploring Patient Stress
timeFrame: Cross-sectional over 1 year
measure: Exploring perspectives of SGM patients
timeFrame: Cross-sectional over 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Charles Kamen, PhD
role: PRINCIPAL_INVESTIGATOR
References: