Prostate CancerNCT00767845
Symptom Management in African-American Men With Localized Prostate Cancer
An observational study of Prostate Cancer and Psychosocial Effects of Cancer and Its Treatment, run by Baylor College of Medicine at 1 site in United States.
Trial summary
RATIONALE: Gathering information about symptom management from patients with localized prostate cancer may help doctors improve patients' quality of life. PURPOSE: This clinical trial is studying symptom management in African-American men with localized prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment
- What is being tested?
- questionnaire/survey administration
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to May 2008
- 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 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Biopsy-proven localized prostate cancer
- Has received treatment for prostate cancer
- Patient self-identifies as being of African-American descent
PATIENT CHARACTERISTICS:
- Able to speak and read in English
- Has an address in order to receive study materials by mail (a street address or post office box)
- Has either a telephone in order to be interviewed OR is able to meet the principal investigator at the Veterans Administration prostate clinic and be interviewed there
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: PROSTATE CANCER SYMPTOM MANAGEMENT FOR LOW LITERACY MEN
RATIONALE: Gathering information about symptom management from patients with localized prostate cancer may help doctors improve patients' quality of life.
PURPOSE: This clinical trial is studying symptom management in African-American men with localized prostate cancer.
Read the detailed description
OBJECTIVES:
- Develop a symptom management intervention for African-American men treated for localized prostate cancer, with a particular emphasis on low health literacy men.
OUTLINE: Participants are interviewed by the principal investigator over the phone or meet the principal investigator at the Veterans Administration prostate cancer clinic. If the interview is conducted in the clinic, it is held in a private room in the clinic.
- Being tested
- questionnaire/survey administration
- Keywords
- psychosocial effects of cancer and its treatment, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire/survey administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom management taxonomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startJun 2006
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: No subjects were enrolled here or at UCSF.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- 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
- NCT00767845
- Sponsor's protocol ID
- CDR0000600455
- Other IDs
- BCM-H-19323
- Status last verified
- Nov 2016
- First submitted
- 4 Oct 2008
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
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
- PROSTATE CANCER SYMPTOM MANAGEMENT FOR LOW LITERACY MEN
- ClinicalTrials.gov ID
- NCT00767845
- Acronym / sponsor ID
- CDR0000600455
- Keywords
- psychosocial effects of cancer and its treatment, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No subjects were enrolled here or at UCSF.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 7 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: Gathering information about symptom management from patients with localized prostate cancer may help doctors improve patients' quality of life.
PURPOSE: This clinical trial is studying symptom management in African-American men with localized prostate cancer.
Detailed description
OBJECTIVES:
- Develop a symptom management intervention for African-American men treated for localized prostate cancer, with a particular emphasis on low health literacy men.
OUTLINE: Participants are interviewed by the principal investigator over the phone or meet the principal investigator at the Veterans Administration prostate cancer clinic. If the interview is conducted in the clinic, it is held in a private room in the clinic.
Study design
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire/survey administration | Other | – |
Primary outcome
Symptom management taxonomy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
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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 Prostate Cancer and Psychosocial Effects of Cancer and Its Treatment, 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?
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: withdrawn, 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 was withdrawn before enrolling participants, so there are no results.
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?
Symptom management taxonomy. 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 9 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.