Mood Disorders Bladder Cancer

Completed

• Conditions: Bladder Cancer

• Registration Number: NCT04036877
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-30
• Study Start: 2019-09-19
• Primary Completion: 2020-01-14
• Study Completion: 2021-08-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 358

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of depression in bladder cancer patients and their caregivers: Patient-Health Questionnaire-9	Data will be assessed through study completion, on average one year	Assessed 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-7	Data will be assessed through study completion, on average one year	Assessed 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-12	Data will be assessed through study completion, on average one year	Assessed 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 caregivers	Data will be assessed through study completion, on average one year	Assessed 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

Trial Locations

Locations (1)

University of Kansas Health System; 🇺🇸 Kansas City, Kansas, United States