NCT01090388

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 16, 2008

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

March 22, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

4.1 years

First QC Date

July 16, 2008

Last Update Submit

November 7, 2016

Conditions

Bladder Neoplasms

Keywords

Cross-sectional surveyHealth-related quality of lifeSymptom management

Outcome Measures

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.

    Duration of Study

Secondary Outcomes (2)

  • Illness intrusiveness

    Duration of Study

  • CaPSURE Fear of Recurrence

    Duration of Study

Study Arms (1)

1

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (3)

  • 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.

    PMID: 19963252BACKGROUND

  • 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.

    PMID: 25356311RESULT

  • 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.

    PMID: 24719024RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • David M Latini, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Urology

Study Record Dates

First Submitted

July 16, 2008

First Posted

March 22, 2010

Study Start

July 1, 2007

Primary Completion

August 1, 2011

Study Completion

November 1, 2016

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations

US(1)