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Completed

NCT Number: NCT05866705

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham School of Nursing

Birmingham, Alabama, 35233-1342, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Daily Depression Symptom Experience

    Time frame: 28 days

    PROMIS Emotional Distress-Depression Short Form, a 4-item scale measuring common symptoms associated with depresison.

  2. Daily Anxiety Symptom Experience

    Time frame: 28 days

    PROMIS Emotional Distress-Anxiety Short Form, a 4-item scale measuring common symptoms associated with anxiety.

  3. Depression

    Time frame: 28 days

    PHQ-9, a 9-item scale for screening, diagnosing, monitoring and measuring the severity of depression.

  4. Anxiety

    Time frame: 28 days

    GAD-7, a 7-item scale for screening, diagnosing, monitoring and measuring the severity of anxiety.

Secondary outcomes

  1. Reslience

    Time frame: 28 days

    Resilience Scale for Adult: a 33-item scale measuring personal competence, social competence, personal structure, family coherence, and social support.

  2. Health Related Quality of Life

    Time frame: 28 days

    PROMIS Global Health: 10 item scale measureing global health-related quality of life (HRQOL) across 2 domains: physical and mental health.

  3. Fraility

    Time frame: 28 days

    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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: SGMC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 19, 2023
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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