Mood Disorders Bladder Cancer

NCT04036877 | Completed

• 1 other identifier: 144280
• Study Type: observational
• Target: 358
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (4)

• Severity of depression in bladder cancer patients and their caregivers: Patient-Health Questionnaire-9

  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.

  Data will be assessed through study completion, on average one year

• Severity of anxiety in bladder cancer patients and their caregivers: Generalized Anxiety Disorder-7

  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.

  Data will be assessed through study completion, on average one year

• Health-related quality of life in bladder cancer patients and their caregivers: Short Form-12

  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.

  Data will be assessed through study completion, on average one year

• Financial Toxicity in bladder cancer patients and their caregivers

  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

  Data will be assessed through study completion, on average one year

Other Outcomes (1)

• 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 year

Interventions

Mood Disorder Assessment OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and caregivers of patients with a diagnosis of bladder cancer who have received treatment at the University of Kansas Health System

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Health System

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Elizabeth Wulff-Burchfield, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 30, 2019
• Study Start: September 19, 2019
• Primary Completion: January 14, 2020
• Study Completion: August 4, 2021
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)