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Bladder Cancer Patient-Reported Outcomes

NCT ID: NCT01090388

Last Updated: 2016-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Neoplasms

Keywords

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Cross-sectional survey Health-related quality of life Symptom management

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

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

No interventions assigned to this group

Eligibility Criteria

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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

* Younger than 18
* Diagnosed BlCa longer than 4 years ago
* Unable to read, speak, and understand English
* Unable to provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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David Latini

Associate Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David M Latini, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19963252 (View on PubMed)

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.

Reference Type RESULT
PMID: 25356311 (View on PubMed)

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.

Reference Type RESULT
PMID: 24719024 (View on PubMed)

Other Identifiers

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SDU07-BlCa-PRO

Identifier Type: -

Identifier Source: org_study_id