- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00815750
Decision Making in Unaffected First-Degree Relatives of Prostate Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Phase 1 - The purpose of this part of the research study is to conduct individual interviews and focus groups (group discussions) to learn more about the things or behaviors that help men to stay healthy and the decision making process for prostate cancer screening. We will discuss men's general health concerns, knowledge, beliefs, and concerns regarding prostate cancer and screening for prostate cancer. We will use the results from this study to develop a decision aid to help first-degree relatives of prostate cancer patients make informed decisions about whether to undergo testing or not to undergo testing for prostate cancer. The new decision aid will include a digital videodisc (DVD) and an accompanying booklet. We hope to learn from you the needs and concerns of first-degree relatives, what information to include in the decision aid, what language to use, and the best way to present this information.
Phase 2 - The purpose of this part of the research study is to test the usefulness and acceptability of a new decision aid we developed specifically for first-degree relatives (FDRs) of prostate cancer patients. We will compare the new decision aid to another widely available decision aid that was not developed specifically for first-degree relatives. The goal is to see if the new decision aid will change knowledge (about prostate cancer and screening) and increase satisfaction with decision making (intention or decision made). If we find some evidence that the new decision aid is relevant (useful) and acceptable, we will then do a larger study with several hundred men to determine more definitively whether the new decision aid is better than already existing general decision materials and for which men it works best.
Because the correct decision (whether to undergo screening or not to undergo screening) is not known at this time, the goal of decision aids is to present both (in a balanced manner) the potential harms and benefits of screening. Therefore, this study focuses on the informed decision making (knowledge and satisfaction with decision).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center & Research Institute
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Tampa, Florida, United States, 33612
- James A. Haley VA Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion/Exclusion Criteria:
- Index Patients - African American and White (non-Hispanic) index patients who have completed definitive treatment for prostate cancer will be approached to participate.
- Index Patients Must: (a) reside in the tri-county Tampa Bay area (Hillsborough, Pinellas and Pasco Counties, FL) to simplify logistics of arranging face-to-face focus groups; (b) be willing to attend a focus group; (c) be able to speak, read and write in English; and (d) be able to provide written informed consent.
- Index patients will be asked to nominate at least one male FDR (son or brother) with no history of prostate cancer.
- Unaffected FDRs - Inclusion criteria for FDRs includes: (a) be non-Hispanic African American or White males between the ages of 40 and 70; (b) have no self-reported history of a diagnosis of any form of cancer (excluding non-melanoma skin cancer), (c) have no self-reported history of prostate biopsy, or transrectal ultrasound to investigate or rule out diagnosis of prostate cancer; (d) have not participated in the phase (formative) portion of this study (i.e., must be "naïve" to the intervention); (e) be able to speak, read and write English; (f) self-report access to a DVD player; and (g) be able to provide written informed consent. FDRs with a relative in active definitive prostate cancer treatment (i.e., surgery, radiotherapy or chemotherapy, except for hormone therapy) or who has completed treatment in the past 30 days will not be eligible. FDRs with multiple living relatives who been diagnosed with prostate cancer will be excluded to reduce heterogeneity of our phase 2 sample; this exclusion criterion is expected to have a minimal influence on accrual in light of our previous data on the percentage of men with multiple affected relatives (less than 5%).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Phase I - Information Gathering
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An information gathering phase leading to development of a new decision aid.
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Other: Phase 2 - Decision Aid
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To test the newly developed decision aid.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aim #1 Formative, Phase 1
Time Frame: 1 day
|
To assess and enhance the Centers for Disease Control and Prevention (CDC)prostate cancer screening decision guides into targeted informed decision aids developed specifically for first-degree relatives of prostate cancer patients.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aim #2 Pilot Intervention, Phase 2
Time Frame: 1 year
|
To assess the feasibility, acceptability and preliminary efficacy of the enhanced decision aids for first degree relatives of prostate cancer patients.
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1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Clement Gwede, H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-15320
- 106302 (Other Identifier: USF IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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