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CompletedNCT04036877Updated Nov 6, 2024

Mood Disorders Bladder Cancer

An observational study in Bladder Cancer, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.

Sponsored by University of Kansas Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
358
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Bladder Cancer
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In context

Urinary Bladder Neoplasms

1,649 studies on the registry are indexed under Urinary Bladder Neoplasms; 427 are open to participants now.

This study's enrollment of 358 is above the median of 179 across 385 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
358 participants (actual)
Patient registry
No

Interventions

  • OtherMood Disorder Assessment

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

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What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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

    Time frame: 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)

    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

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

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Study locations

1 site
  • University of Kansas Health System
    Kansas City, Kansas 66160, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04036877
Responsible party
Elizabeth Wulff-Burchfield, MD (Principal Investigator, University of Kansas Medical Center) — Principal investigator
First posted
Jul 30, 2019
Start date
Sep 19, 2019
Primary completion
Jan 14, 2020
Completion
Aug 4, 2021
Last update
Nov 6, 2024

Study contacts

Elizabeth Wulff-Burchfield, MD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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