DepressionSGMCNCT05866705
The Mental Health Experiences of Sexual and Gender Minorities Living With Cancer and Their Care Partners
An observational study of Depression and Anxiety, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Caregiver Burden
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2023to 27 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: LGBTQIA+ Individuals living with cancer (aged 55+) and their care partners (aged 21+)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham School of Nursing
Birmingham, Alabama, 35233-1342
About this study
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.
Read the 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.
- Conditions
- Depression, Anxiety, Caregiver Burden, Stress, Chronic Illness
- Keywords
- cancer, mental health, LGBTQIA+
- Medical subject headings
- Depression, Anxiety Disorders, Caregiver Burden, Chronic Disease, Neoplasms, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer | Individuals living with cancer | |
| Care Partner | Care partner for someone who is living with cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Depression Symptom Experience
PROMIS Emotional Distress-Depression Short Form, a 4-item scale measuring common symptoms associated with depresison.
Measured: 28 days
Daily Anxiety Symptom Experience
PROMIS Emotional Distress-Anxiety Short Form, a 4-item scale measuring common symptoms associated with anxiety.
Measured: 28 days
Depression
PHQ-9, a 9-item scale for screening, diagnosing, monitoring and measuring the severity of depression.
Measured: 28 days
Anxiety
GAD-7, a 7-item scale for screening, diagnosing, monitoring and measuring the severity of anxiety.
Measured: 28 days
Secondary outcomes (3)
Reslience
Resilience Scale for Adult: a 33-item scale measuring personal competence, social competence, personal structure, family coherence, and social support.
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start3 Apr 2023
- Primary completion15 Jun 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Puga, University of Alabama at Birmingham
- Investigators
- Frank Puga, Principal investigator, University of Alabama at Birmingham School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866705
- Sponsor's protocol ID
- IRB-300009168
- Other IDs
- PREP Award
- Acronym
- SGMC
- Status last verified
- Jun 2025
- First submitted
- 10 May 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mental Health Experiences of Sexual and Gender Minorities Living With Cancer and Their Care Partners
- ClinicalTrials.gov ID
- NCT05866705
- Acronym / sponsor ID
- SGMC / IRB-300009168
- Conditions
- Depression, Anxiety, Caregiver Burden, Stress, Chronic Illness
- Keywords
- cancer, mental health, LGBTQIA+
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer | – | –Individuals living with cancer |
| Care Partner | – | –Care partner for someone who is living with cancer |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- LGBTQIA+ Individuals living with cancer (aged 55+) and their care partners (aged 21+)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Daily Depression Symptom Experience
Time frame: 28 days
PROMIS Emotional Distress-Depression Short Form, a 4-item scale measuring common symptoms associated with depresison.
Daily Anxiety Symptom Experience
Time frame: 28 days
PROMIS Emotional Distress-Anxiety Short Form, a 4-item scale measuring common symptoms associated with anxiety.
Depression
Time frame: 28 days
PHQ-9, a 9-item scale for screening, diagnosing, monitoring and measuring the severity of depression.
Anxiety
Time frame: 28 days
GAD-7, a 7-item scale for screening, diagnosing, monitoring and measuring the severity of anxiety.
3 secondary outcomes
Reslience
Time frame: 28 days
Health Related Quality of Life
Time frame: 28 days
Fraility
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Puga principal investigator
University of Alabama at Birmingham School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Depression Symptom Experience (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.