Clinical trial NCT05866705: The Mental Health Experiences of Sexual and Gender Minorities Living With Cancer and Their Care Partners
Official title: The Mental Health Experiences of Sexual and Gender Minorities Living With Cancer and Their Care Partners
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Anxiety
Caregiver Burden
Stress
Chronic Illness
Keywords: cancer
mental health
LGBTQIA+
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: LGBTQIA+ Individuals living with cancer (aged 55+) and their care partners (aged 21+)

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Daily Depression Symptom Experience
timeFrame: 28 days
measure: Daily Anxiety Symptom Experience
timeFrame: 28 days
measure: Depression
timeFrame: 28 days
measure: Anxiety
timeFrame: 28 days
Secondary outcomes:
measure: Reslience
timeFrame: 28 days
measure: Health Related Quality of Life
timeFrame: 28 days
measure: Fraility
timeFrame: 28 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham School of Nursing
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham School of Nursing
name: Frank Puga
role: PRINCIPAL_INVESTIGATOR
References: