Bladder NeoplasmsNCT01090388
Bladder Cancer Patient-Reported Outcomes
An observational study of Bladder Neoplasms, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Neoplasms
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Nov 2016
- 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: 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
Who may be able to join
- > 18 years
- Diagnosed with BlCa within the past 4 years
- Able to read, speak, and understand English
- Able to provide informed consent.
Who cannot join
- Younger than 18
- Diagnosed BlCa longer than 4 years ago
- Unable to read, speak, and understand English
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-Sectional Study Of Patient-Reported Outcomes For Bladder Cancer Patients With Non-Invasive Disease
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.
- Conditions
- Bladder Neoplasms
- Keywords
- Cross-sectional survey, Health-related quality of life, Symptom management
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants voluntarily completed a telephone interview using a questionnaire compiled using validated, patient-centered measures of cancer outcomes and psychosocial status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of Study
Secondary outcomes (2)
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.
Measured: Duration of Study
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.
Measured: Duration of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startJul 2007
- Primary completionAug 2011
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Principal 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
- NCT01090388
- Sponsor's protocol ID
- SDU07-BlCa-PRO
- Status last verified
- Nov 2016
- First submitted
- 16 Jul 2008
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
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 19963252Kowalkowski 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 25356311Kowalkowski 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Study Of Patient-Reported Outcomes For Bladder Cancer Patients With Non-Invasive Disease
- ClinicalTrials.gov ID
- NCT01090388
- Acronym / sponsor ID
- SDU07-BlCa-PRO
- Conditions
- Bladder Neoplasms
- Keywords
- Cross-sectional survey, Health-related quality of life, Symptom management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Jul 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 22 Mar 2010 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Participants voluntarily completed a telephone interview using a questionnaire compiled using validated, patient-centered measures of cancer outcomes and psychosocial status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- > 18 years
- Diagnosed with BlCa within the past 4 years
- Able to read, speak, and understand English
- Able to provide informed consent.
Key exclusion criteria (4 listed)
- Younger than 18
- Diagnosed BlCa longer than 4 years ago
- Unable to read, speak, and understand English
- Unable to provide informed consent.
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 as measured by the EORTC QLQ C30 and BLS24 (nonmuscle-invasive) or BLM30 (muscle-invasive or metastatic)
Time frame: Duration of Study
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.
2 secondary outcomes
Illness intrusiveness
Time frame: Duration of Study
CaPSURE Fear of Recurrence
Time frame: Duration of Study
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 9 Nov 2016.
- Background: PubMed 19963252Latini 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.
- Results publication: PubMed 25356311Kowalkowski 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.
- Results publication: PubMed 24719024Kowalkowski 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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Neoplasms, run by Baylor College of Medicine at 1 site 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?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 as measured by the EORTC QLQ C30 and BLS24 (nonmuscle-invasive) or BLM30 (muscle-invasive or metastatic) (time frame: Duration of Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090388, which also lists 3 linked publications.
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 9 Nov 2016.