Prostate CancerNCT00769431
Evaluating Symptom Management Educational Materials for Patients With Prostate Cancer
A study testing educational intervention and study of socioeconomic and demographic variables in people with Prostate Cancer, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
RATIONALE: Collecting feedback from patients with prostate cancer may help doctors develop better symptom management educational materials for patients. PURPOSE: This clinical trial is evaluating symptom management educational materials for patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- educational intervention and study of socioeconomic and demographic variables
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Jul 2009
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Biopsy-proven prostate cancer
- Localized disease that has been previously treated
- Selected for participation from 1 of the following:
- Convenience sample of men from the Baylor College of Medicine (BCM) Urology clinics at Scurlock Tower (including the Urology clinic at MEDVAMC) and local prostate cancer-support groups
- Prostate cancer survivors who participated in the US TOO Father's Day Walk/Run or the Gay Pride Celebration
PATIENT CHARACTERISTICS:
- Able to speak and read in English
- Willing to review the written patient educational materials and discuss them in a group setting
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
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: FOCUS GROUP EVALUATION OF PROSTATE CANCER SYMPTOM MANAGEMENT EDUCATION MATERIALS
RATIONALE: Collecting feedback from patients with prostate cancer may help doctors develop better symptom management educational materials for patients.
PURPOSE: This clinical trial is evaluating symptom management educational materials for patients with prostate cancer.
Read the detailed description
OBJECTIVES:
- To collect formative evaluation data about a new educational intervention using focus groups of patients with prostate cancer.
- To use the focus group data in the master's research paper of a Baylor College of Medicine physician-assistant student who is documenting the process of organizing and conducting the focus groups, enumerating areas where the new materials are deemed problematic, and identifying themes in the comments made by the focus group participants.
OUTLINE: Study participants are assigned to 1 of 3 focus groups according to educational level and ethnicity (i.e., lower educational-level African-American men primarily from the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC); lower educational-level Caucasian men from MEDVAMC, Baylor College of Medicine (BCM), or the community; or higher educational-level Caucasian men primarily from BCM or the community).
Participants review written patient educational-intervention materials on prostate cancer and provide feedback to the investigator on the content and acceptability of these materials during a 1½-2-hour focus group discussion. Feedback data are used to revise the intervention materials so that they are appropriate to the target population.
- Conditions
- Prostate Cancer
- Being tested
- educational intervention, study of socioeconomic and demographic variables
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA 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.
educational interventionOther
study of socioeconomic and demographic variablesOther
| Study group | Role | What they receive |
|---|---|---|
| Focus group | No intervention | Not described Receives: Other: educational intervention; Other: study of socioeconomic and demographic variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the written patient educational materials, in terms of text size, white space, font, and graphics
Measured: Single timepoint
Formative evaluation of the new educational materials, in terms of the comments made by the focus group participants
Measured: Single timepoint
Validation that the goals of the educational-intervention instruction are being achieved
Measured: Single timepoint
Improvement of the educational-intervention instruction by identification and remediation of problems
Measured: Single timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2009
- Study completionJul 2009
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 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
- NCT00769431
- Sponsor's protocol ID
- CDR0000600594
- Other IDs
- BCM-H-21622
- Status last verified
- Jul 2013
- First submitted
- 8 Oct 2008
- Last updated
- 26 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOCUS GROUP EVALUATION OF PROSTATE CANCER SYMPTOM MANAGEMENT EDUCATION MATERIALS
- ClinicalTrials.gov ID
- NCT00769431
- Acronym / sponsor ID
- CDR0000600594
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 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: Collecting feedback from patients with prostate cancer may help doctors develop better symptom management educational materials for patients.
PURPOSE: This clinical trial is evaluating symptom management educational materials for patients with prostate cancer.
Detailed description
OBJECTIVES:
- To collect formative evaluation data about a new educational intervention using focus groups of patients with prostate cancer.
- To use the focus group data in the master's research paper of a Baylor College of Medicine physician-assistant student who is documenting the process of organizing and conducting the focus groups, enumerating areas where the new materials are deemed problematic, and identifying themes in the comments made by the focus group participants.
OUTLINE: Study participants are assigned to 1 of 3 focus groups according to educational level and ethnicity (i.e., lower educational-level African-American men primarily from the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC); lower educational-level Caucasian men from MEDVAMC, Baylor College of Medicine (BCM), or the community; or higher educational-level Caucasian men primarily from BCM or the community).
Participants review written patient educational-intervention materials on prostate cancer and provide feedback to the investigator on the content and acceptability of these materials during a 1½-2-hour focus group discussion. Feedback data are used to revise the intervention materials so that they are appropriate to the target population.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus group | No intervention | Other: educational intervention, Other: study of socioeconomic and demographic variables |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| educational intervention | Other | Focus group |
| study of socioeconomic and demographic variables | Other | Focus group |
Primary outcome
Acceptability of the written patient educational materials, in terms of text size, white space, font, and graphics
Time frame: Single timepoint
Formative evaluation of the new educational materials, in terms of the comments made by the focus group participants
Time frame: Single timepoint
Validation that the goals of the educational-intervention instruction are being achieved
Time frame: Single timepoint
Improvement of the educational-intervention instruction by identification and remediation of problems
Time frame: Single timepoint
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 26 Jul 2013.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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?
A study testing educational intervention and study of socioeconomic and demographic variables in people with Prostate Cancer, run by Baylor College of Medicine 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 26 Jul 2013. 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?
Acceptability of the written patient educational materials, in terms of text size, white space, font, and graphics (time frame: Single timepoint). The study lists 4 primary outcomes in all. 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 26 Jul 2013.