Mood Disorders Bladder Cancer

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

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

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer
• Intervention / Treatment: Other: Mood Disorder Assessment

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	This 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	Data will be assessed through study completion, on average one year

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2019
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Mood Disorders
• Other Study ID Numbers: 144280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No