The Mental Health Experiences of Sexual and Gender Minorities Living With Cancer and Their Care Partners

Depression Clinical Trial

— SGMC  

Official title:

The Mental Health Experiences of Sexual and Gender Minorities Living With Cancer and Their Care Partners

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05866705
• Other study ID #: IRB-300009168
• Secondary ID: PREP Award
• Status: Recruiting
• Start date: April 3, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: Elisha Underwood
• Phone: 9169344224
• Email: ecund[@]uab.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine relationships between contextual stressors and stress moderators, depression symptom experience, resilience, frailty, and quality of life among older sexual gender minorities cancer survivors and their care partners.

Description:

A priority focus in palliative care is supporting the well-being and mental health of older adults living with cancer and their care partners, particularly among populations carrying a disproportionate cancer burden, such as sexual and gender minorities (SGM). Previous reports indicate that SGMs experience increased cancer risk, less effective care, and poor outcomes than heterosexual, cis-gendered, and gender binary individuals. Thus, it is imperative to understand better the palliative and end-of-life (EOL) care needs of SGM cancer survivors and their care partners.

Recent studies have found that SGM individuals living with cancer report more depression than their heterosexual counterparts. These findings are concerning as increased distress and adverse mental health outcomes among individuals living with cancer have been shown to exacerbate symptom burden, impact disease progression, and increase the risk of suicide. Further, the care partners of SGM individuals living with cancer often serve as informal caregivers and may experience increased stress due to their loved one's diagnosis and disease progression. Such caregiving-related stress has been shown to increase the risk of late-life serious mental illness, accelerated aging, and age-related diseases. There is a critical need for culturally appropriate palliative care and EOL interventions that support the well-being of SGM individuals living with cancer and their care partners.

Further, limited knowledge exists on the relationship between daily and long-term patterns of psychological distress, specifically depression symptom experience, and changes in resilience (i.e., the capacity for positive adaptation despite adversity), frailty, and poor quality of life (QoL) over time. A failure to address this gap will result in continued health disparities in an underserved population in aging and palliative care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria

Individual living with cancer: 1) self-identifies as a sexual and/or gender minority; 2) =55 years of age; 3) diagnosed with cancer (stages 1 through 4), including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, melanoma; and hematologic malignancies.

Care Partner: 1) =21 years of age; 2) self-identifies as a care partner of a sexual and/or gender minority diagnosed with cancer (stages 1 through 4), including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, melanoma; and hematologic malignancies.

Exclusion Criteria

Individual living with cancer: 1) Medical documentation of active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, suicidal ideation, uncorrected hearing loss, or substance abuse; 2) does not have reliable internet access.

Care Partner: 1) Self-reported mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse; 2) does not have reliable internet access.

Related Conditions & MeSH terms

• Anxiety
• Caregiver Burden
• Chronic Disease
• Chronic Illness
• Depression
• Stress

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham School of Nursing	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Depression Symptom Experience	PROMIS Emotional Distress-Depression Short Form, a 4-item scale measuring common symptoms associated with depresison.	28 days
Primary	Daily Anxiety Symptom Experience	PROMIS Emotional Distress-Anxiety Short Form, a 4-item scale measuring common symptoms associated with anxiety.	28 days
Primary	Depression	PHQ-9, a 9-item scale for screening, diagnosing, monitoring and measuring the severity of depression.	28 days
Primary	Anxiety	GAD-7, a 7-item scale for screening, diagnosing, monitoring and measuring the severity of anxiety.	28 days
Secondary	Reslience	Resilience Scale for Adult: a 33-item scale measuring personal competence, social competence, personal structure, family coherence, and social support.	28 days
Secondary	Health Related Quality of Life	PROMIS Global Health: 10 item scale measureing global health-related quality of life (HRQOL) across 2 domains: physical and mental health.	28 days
Secondary	Fraility	Cancer & Aging Resilience Evaluation (CARE) Frailty Index: a 44-item scale that utilizes the principles of deficit accumulation to assess an individuals level of fraility.	28 days