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Mood Disorders Bladder Cancer

Evaluation of Mood Disorders in Bladder Cancer Patients and Their Primary Caregivers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04036877
Enrollment
358
Registered
2019-07-30
Start date
2019-09-19
Completion date
2021-08-04
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Brief summary

This is a cross-sectional study evaluating mood disorders in bladder cancer patients and their caregivers across the bladder cancer trajectory

Interventions

OTHERMood Disorder Assessment

Assess depression, anxiety, HRQOL, and financial toxicity in both bladder cancer patients and their caregivers via telephone survey

Sponsors

University of Kansas Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients or caregiver of patient with a histologic diagnosis of bladder cancer of the following subtypes, urothelial carcinoma, adenocarcinoma, or squamous cell carcinoma, within 24 months of survey administration and received treatment at the University of Kansas Health System * ≥ 18 years of age * Have a patient-designated primary informal/family caregiver * Able to speak and read English * Willing and able to provide informed consent * Functioning telephone number or access to one

Exclusion criteria

* Patients or caregivers of patients with metastatic bladder cancer * Patients who are unable to designate a primary caregiver * Patients and caregivers who do not both consent to study participation

Design outcomes

Primary

MeasureTime frameDescription
Severity of depression in bladder cancer patients and their caregivers: Patient-Health Questionnaire-9Data will be assessed through study completion, on average one yearAssessed using Patient-Health Questionnaire-9. A standard questionnaire with 9 questions. Score 5-9 is minimal symptoms, 10-14 is minor depression, 15-19 is major depression moderately severe, and 20-27 is severe major depression.
Severity of anxiety in bladder cancer patients and their caregivers: Generalized Anxiety Disorder-7Data will be assessed through study completion, on average one yearAssessed using Generalized Anxiety Disorder-7. A standard questionnaire composed of seven questions with scores ranging from 0 to 21. A score between 5 and 9 indicates mild anxiety, a score between 10 and 14 indicates moderate anxiety, and a score 15 or above indicates severe anxiety.
Health-related quality of life in bladder cancer patients and their caregivers: Short Form-12Data will be assessed through study completion, on average one yearAssessed using Short Form-12. A standard questionnaire with twelve questions, with a score from 0 to 100, where a zero indicates lowest level of health and 100 indicates highest level of health.
Financial Toxicity in bladder cancer patients and their caregiversData will be assessed through study completion, on average one yearAssessed using single-item financial toxicity measure. The measure asks patients to indicate number that best describes their financial stress during pass week from a scale of 0 to 10 with 0 indicating no financial distress and 10 indicating extreme financial distress

Other

MeasureTime frameDescription
Assess the correlation between caregiver depression, anxiety, and HRQOL and four primary domains of caregiver needs (accessing health services, psychological and emotional needs, work and social needs, and informational needs)Data will be assessed through study completion, on average one yearThis will be assessed using limited questions from the Supportive Care Needs Survey Partners and Caregivers (SCNS-P&C45) Questionnaire. This questionnaire has one question on health care service needs, two on psychological and emotional needs, three on work and social needs, and two on information needs. Each question is scored from one to five with a higher score indicating higher needs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026