Community Interventions in Non-Medical Settings to Increase Informed Decision Making for Prostate Cancer Screening
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to develop and evaluate a computer-based decision aid (DA) for use by men considering PSA screening for prostate cancer. Major medical organizations recommend that men discuss the risks and benefits of this test with their physician before making the decision. This educational, interactive DA will help them prepare for that discussion.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Behavioral: Computer-based prostate cancer screening decision aid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training |
| Official Title: | Community Interventions in Non-Medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Harvard - SIP 21-04 |
- 1.Informed Decision Making
- 1.Satisfaction with Decision Making Process and Decision
- 2.Decisional conflict
- *All measures assessed at baseline and follow up survey and will be completed by month 6 of year 3 of the study
| Estimated Enrollment: | 1120 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | September 2007 |
Prostate cancer (CaP) is a formidable public health problem in the US and in industrialized countries worldwide. Methods for primary prevention of CaP are unknown. As a result, early detection has become a mainstay of cancer control efforts. However, there is considerable controversy regarding the efficacy of screening in reducing disease-specific mortality. In light of this uncertainty, major medical organizations, including the National Cancer Institute, currently recommend that men discuss the pros and cons of CaP screening and make individualized screening decisions with their health care providers. However, because of constraints on time during medical encounters, it is not always feasible for providers to engage in in-depth discussions regarding the complexities of this issue. Therefore, interventions to promote informed decision-making (IDM) outside of clinical settings are needed.
In this study, we propose to: (1) develop an interactive computer-based decision aid (DA) to promote IDM for CaP screening; and (2) conduct a randomized controlled worksite trial to evaluate the impact the DA intervention on employed men’s ability to make informed decisions regarding CaP. This work is designed to be responsive to recent calls for IDM interventions in community settings among diverse populations. If successful, our findings could validate the effectiveness of DAs to promote IDM for CaP and serve as a model for widespread dissemination, thus improving quality of care.
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Worksites employing at least 100 men in target age group (45-65 years old)
Exclusion Criteria:
- Worksites with high turnover
- Non-English speaking workers
- Temporary or contract workers
Contacts and Locations| Contact: Jennifer D Allen, PN, MPH, ScD | 617-632-2269 | jennifer_allen@dfci.harvard.edu |
| Contact: Elizabeth A Harden, BA | 617-632-2185 | elizabeth_harden@dfci.harvard.edu |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Jennifer D Allen, PN MPH PhD 617-632-2269 jennifer_allen@dfci.harvard.edu | |
| Contact: Elizabeth A Harden, BA 617-632-2185 elizabeth_harden@dfci.harvard.edu | |
| Principal Investigator: Jennifer D Allen, PN MPH ScD | |
| Principal Investigator: | Jennifer D Allen, PN MPH ScD | Dana-Farber Cancer Institute; Harvard School of Public Health |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00207636 History of Changes |
| Other Study ID Numbers: | CDC-NCCDPHP-2504 |
| Study First Received: | September 15, 2005 |
| Last Updated: | September 15, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Centers for Disease Control and Prevention:
|
Computer-Assisted Decision Making Workplace Screening |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013