Mood Disorders Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04036877
• Other study ID #: 144280
• Status: Recruiting
• Start date: September 19, 2019
• Est. completion date: July 2021

Study information

• Verified date: October 2019
• Source: University of Kansas Medical Center
• Contact: Alexandra Dahlgren
• Phone: 913-574-0847
• Email: adahlgren[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Mood Disorders
• Urinary Bladder Neoplasms

Intervention

Other:
• Mood Disorder Assessment
Assess depression, anxiety, HRQOL, and financial toxicity in both bladder cancer patients and their caregivers via telephone survey

Locations

Country	Name	City	State
United States	University of Kansas Health System	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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