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CompletedNCT01090388Updated Nov 9, 2016

Bladder Cancer Patient-Reported Outcomes

An observational study in Bladder Neoplasms, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-09.

Sponsored by Baylor College of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
108
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to identify aspects of the bladder cancer (BlCa) survivorship experience that differ by clinical risk at diagnosis. The investigators will collect cross-sectional data from persons with BlCa to identify aspects of health-related quality of life (HRQOL) and symptom management. The study originally enrolled only nonmuscle-invasive bladder cancer survivors but has been expanded to include survivors with any stage disease. Information from this study will be used to develop a new patient education and counseling intervention.

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Conditions studied

  • Bladder Neoplasms

Keywords

  • Cross-sectional survey
  • Health-related quality of life
  • Symptom management
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In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 108 is below the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) 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

Bladder cancer patients (all stages) recruited at hospitals affiliated with Baylor College of Medicine and MD Anderson Cancer Center and via the websites of bladder cancer survivor organizations

Inclusion criteria

  • > 18 years
  • Diagnosed with BlCa within the past 4 years
  • Able to read, speak, and understand English
  • Able to provide informed consent.

Exclusion criteria

Exclusion Criteria:

  • Younger than 18
  • Diagnosed BlCa longer than 4 years ago
  • Unable to read, speak, and understand English
  • Unable to provide informed consent.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
108 participants (actual)

Groups and cohorts

  • 1

    Participants voluntarily completed a telephone interview using a questionnaire compiled using validated, patient-centered measures of cancer outcomes and psychosocial status.

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What researchers measure

Primary outcomes

  1. Health-related quality of life as measured by the EORTC QLQ C30 and BLS24 (nonmuscle-invasive) or BLM30 (muscle-invasive or metastatic)

    Health-related quality of life as measured by the European Organization for Resarch and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and BLS24 (that is, BLadder cancer Superficial, meaning nonmuscle-invasive) or BLM30 (BLadder cancer muscle-invasive or metastatic). Data are assessed at one time point only. Survey participants may be assessed at any point between diagnosis and 4 years post-diagnosis. The questions in the survey typically ask about health-related quality of life in the preceding 4 weeks.

    Time frame: Duration of Study

Secondary outcomes

  1. Illness intrusiveness

    Data are assessed at one time point only. Survey participants may be assessed at any point between diagnosis and 4 years post-diagnosis. The questions in the survey typically ask about health-related quality of life in the preceding 4 weeks.

    Time frame: Duration of Study

  2. CaPSURE Fear of Recurrence

    The fear of recurrence measure was originally developed and validated for the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) study. Data are assessed at one time point only. Survey participants may be assessed at any point between diagnosis and 4 years post-diagnosis. The questions in the survey typically ask about health-related quality of life in the preceding 4 weeks.

    Time frame: Duration of Study

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Study locations

1 site
  • Baylor College of Medicine
    Houston, Texas 77030, United States
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References and documents

Publications

  • Latini DM, Lerner SP, Wade SW, Lee DW, Quale DZ. Bladder cancer detection, treatment and outcomes: opportunities and challenges. Urology. 2010 Feb;75(2):334-9. doi: 10.1016/j.urology.2009.09.051. Epub 2009 Dec 5. PubMed 19963252 ↗
  • Kowalkowski MA, Chandrashekar A, Amiel GE, Lerner SP, Wittmann DA, Latini DM, Goltz HH. Examining sexual dysfunction in non-muscle-invasive bladder cancer: results of cross-sectional mixed-methods research. Sex Med. 2014 Aug;2(3):141-51. doi: 10.1002/sm2.24. PubMed 25356311 ↗
  • Kowalkowski MA, Goltz HH, Petersen NJ, Amiel GE, Lerner SP, Latini DM. Educational opportunities in bladder cancer: increasing cystoscopic adherence and the availability of smoking-cessation programs. J Cancer Educ. 2014 Dec;29(4):739-45. doi: 10.1007/s13187-014-0649-3. PubMed 24719024 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2016, 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
NCT01090388
Lead sponsor
Baylor College of Medicine
Collaborators
M.D. Anderson Cancer Center
Responsible party
David Latini (Associate Professor of Urology, Baylor College of Medicine) — Principal investigator
First posted
Mar 22, 2010
Start date
Jul 2007
Primary completion
Aug 2011
Completion
Nov 2016
Last update
Nov 9, 2016

Study contacts

David M Latini, PhD
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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