Bladder CancerNCT00772018
Quality of Life and Symptom Management in Patients With Bladder Cancer
An observational study of Bladder Cancer, run by David Latini at 2 sites in United States.
Trial summary
RATIONALE: Learning about quality of life and symptom management in patients with bladder cancer may help doctors learn about the effects of treatment and plan the best treatment. PURPOSE: This clinical trial is studying of quality of life and symptom management in patients with bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Urology specialty clinic
DISEASE CHARACTERISTICS:
- Diagnosis of bladder cancer within the past 4 years
- Non-invasive disease
- Low- or high-risk disease
- Recruited from patients at the Baylor College of Medicine Scott Department of Urology clinics, the Michael E. DeBakey Veteran Affairs Medical Center, and the Urology Clinic at MD Anderson Cancer Center OR from participants at a community event
PATIENT CHARACTERISTICS:
- Not pregnant
- Able to read, speak, and understand English
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, 77030
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
About this study
Official title: A Qualitative Study of Patients With Non-Invasive Bladder Cancer
RATIONALE: Learning about quality of life and symptom management in patients with bladder cancer may help doctors learn about the effects of treatment and plan the best treatment.
PURPOSE: This clinical trial is studying of quality of life and symptom management in patients with bladder cancer.
Read the detailed description
OBJECTIVES:
Primary
- To identify aspects of health-related quality of life (HRQOL) and symptom management in patients with non-invasive, low- or high-risk bladder cancer.
- To obtain feedback on data collection methods to enhance acceptability in these patients.
OUTLINE: Patients undergo a 10-minute screening in person or by phone to obtain demographic data and medical information (e.g., bladder cancer diagnosis and treatment history). Additional information is obtained from the clinical databases at the Baylor College of Medicine and the Michael E. DeBakey Veterans Affairs Medical Center. Patients who are eligible for the study are added to a waiting list for 1 of 4 focus groups based on disease status (high-risk or low-risk non-invasive bladder cancer) and gender. Patients participate in a 1.5- to 2-hour focus group discussion about the impact of bladder cancer on their quality of life and relationships. Patients receive information about community and Internet-based resources at the end of each group session.
- Conditions
- Bladder Cancer
- Keywords
- stage 0 bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (HRQOL) and symptom management in patients with bladder cancer
Study is a retrospective qualitative study of nonmuscle-invasive bladder cancer patients using a semi-structured interview protocol.
Measured: One timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Latini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Latini, Baylor College of Medicine
- Investigators
- David M. Latini, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772018
- Sponsor's protocol ID
- CDR0000600591
- Other IDs
- BCM-H-21570
- Status last verified
- Feb 2012
- First submitted
- 12 Oct 2008
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study of Patients With Non-Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT00772018
- Acronym / sponsor ID
- CDR0000600591
- Conditions
- Bladder Cancer
- Keywords
- stage 0 bladder cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- David LatiniUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Learning about quality of life and symptom management in patients with bladder cancer may help doctors learn about the effects of treatment and plan the best treatment.
PURPOSE: This clinical trial is studying of quality of life and symptom management in patients with bladder cancer.
Detailed description
OBJECTIVES:
Primary
- To identify aspects of health-related quality of life (HRQOL) and symptom management in patients with non-invasive, low- or high-risk bladder cancer.
- To obtain feedback on data collection methods to enhance acceptability in these patients.
OUTLINE: Patients undergo a 10-minute screening in person or by phone to obtain demographic data and medical information (e.g., bladder cancer diagnosis and treatment history). Additional information is obtained from the clinical databases at the Baylor College of Medicine and the Michael E. DeBakey Veterans Affairs Medical Center. Patients who are eligible for the study are added to a waiting list for 1 of 4 focus groups based on disease status (high-risk or low-risk non-invasive bladder cancer) and gender. Patients participate in a 1.5- to 2-hour focus group discussion about the impact of bladder cancer on their quality of life and relationships. Patients receive information about community and Internet-based resources at the end of each group session.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Urology specialty clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-related quality of life (HRQOL) and symptom management in patients with bladder cancer
Time frame: One timepoint
Study is a retrospective qualitative study of nonmuscle-invasive bladder cancer patients using a semi-structured interview protocol.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M. Latini, PhD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by David Latini at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (HRQOL) and symptom management in patients with bladder cancer (time frame: One timepoint). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.