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Completed

NCT Number: NCT04036877

Mood Disorders Bladder Cancer

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Health System

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mood Disorder Assessment

Other

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Financial Toxicity in bladder cancer patients and their caregivers

    Time frame: 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

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)

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

    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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 30, 2019
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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