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Home > "F" Clinical Trials Conditions > Facilitating Shared Decisionmaking About Prostate Cancer Screening  Facilitating Shared Decisionmaking About Prostate Cancer Screening
Facilitating Shared Decisionmaking About Prostate Cancer Screening
For Condition: Prostate Cancer
Status: No longer recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Health Services Research and Development Service
Synopsis: Prostate cancer (CaP) is the most common cancer affecting males in the United States and the second leading cause of cancer death in this population. Both patients and providers are motivated to identify effective means for reducing these significant burdens imposed by CaP. However, conclusive evidence that CaP early detection and treatment can improve survival is lacking. Hence, most authorities recommend against mass CaP screening and suggest instead that providers equip their patients with information necessary for making a sound personal decision regarding screening. However, methods to effectively and efficiently provide patients with this information have not yet been identified. The primary objective of the study is to assess the relative effect of the interventions on the proportion of patients who are well informed about the potential risks and benefits of CaP screening. Secondary objectives of the study are: 1) to assess the impact of the interventions on broad CaP screening knowledge, CaP screening and treatment preferences, patient decisionmaking readiness, participation in decisionmaking, satisfaction with decision, and PSA testing rates; 2) to assess the durability of the intervention effects on CaP screening knowledge and preferences over time; and 3) to assess the relative cost-effectiveness of the two interventions for increasing the proportion of patients that are well informed about the risks and benefits of CaP screening. A total of 1,140 male veterans age 50 and older with primary care appointments at one of four VA medical facilities in VISN 13 will be randomly assigned to three study groups: 1) mailed pamphlet intervention; 2) mailed video intervention; or 3) usual care (control). The sample will be stratified by medical facility, age (50-69, 70+) and PSA in the past year (yes, no). The primary outcome measure is whether a veteran is well informed about the risks and benefits of CaP screening, defined as whether they correctly answer a series of questions on CaP screening in a telephone survey conducted approximately two weeks post intervention.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Active Control, Single Group Assignment
Minimum Age/Maximum Age: 50 Years/
Genders: Male
Protocol Entry Criteria: Patients must be male veterans, age 50 and older, with a scheduled primary care appointment at one of 5 VISN 13 medical facilities. Patients diagnosed with prostate cancer will be excluded.
Total Enrollment: 1152
Location and Contact Information:
VA Medical Center
Minneapolis, Minnesota, 55417
United States
VA Medical Center
Minneapolis, Minnesota, 55417
United States
VA Medical Center
Minneapolis, Minnesota, 55417
United States
VA Medical Center
Minneapolis, Minnesota, 55417
United States
VA Medical Center
Minneapolis, Minnesota, 55417
United States
Additional Information:
Study ID Numbers: IIR 99-277;
Study Start Date: July 2000
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00013247
Other Prostate Cancer Studies:
1. Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
2. Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients
3. Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
4. ET-743 in Men with Advanced Prostate Cancer
5. Gene-Environment Interaction in Prostate Cancer
Related Studies:
Other Prostate Cancer Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Facilitating Shared Decisionmaking About Prostate Cancer Screening
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