NCT05866705

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2024

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

May 10, 2023

Last Update Submit

June 19, 2025

Conditions

Keywords

cancermental healthLGBTQIA+

Outcome Measures

Primary Outcomes (4)

  • Daily Depression Symptom Experience

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

    28 days

  • Daily Anxiety Symptom Experience

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

    28 days

  • Depression

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

    28 days

  • Anxiety

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

    28 days

Secondary Outcomes (3)

  • Reslience

    28 days

  • Health Related Quality of Life

    28 days

  • Fraility

    28 days

Study Arms (2)

Cancer

Individuals living with cancer

Care Partner

Care partner for someone who is living with cancer

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

LGBTQIA+ Individuals living with cancer (aged 55+) and their care partners (aged 21+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham School of Nursing

Birmingham, Alabama, 35233-1342, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersCaregiver BurdenChronic DiseaseNeoplasmsPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersStress, PsychologicalDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPersonal Satisfaction

Study Officials

  • Frank Puga

    University of Alabama at Birmingham School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 19, 2023

Study Start

April 3, 2023

Primary Completion

June 15, 2024

Study Completion

August 27, 2024

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations