Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432601
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2007-02-06
Brief Title:
Testing the Helpfulness of 2 Decision Aids for Prostate Cancer
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Impact of a Plain Language Prostate Cancer Decision Aid on Decision Making
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test different methods for communicating information about prostate cancer treatment to men The investigators are studying how best to present information so men can make informed decisions about what prostate cancer treatment to undergo
Detailed Description:
BackgroundRationale Prostate cancer is the second leading cause of cancer related death among men in the United States and accounts for 29 of all cancers diagnosed in men Furthermore approximately one in six men will be diagnosed with prostate cancer in their lifetime Thus 17 of male Veterans will be asked to make a decision about the treatment of their prostate cancer The burden of this disease is further magnified when one considers that most patients will live for years following their diagnosis and with any adverse effects of therapy Given that there have been no clinical trials showing that any prostate cancer treatment produces an increased likelihood of survival men are asked to actively participate in treatment decisions Previous research has revealed that men are often uninformed about their prostate cancer particularly African American men and men with lower educational attainment Thus it is critical to develop and test decision aids that can help all men especially men with low literacy skills make an informed decision
Objectives The goal of the study is to compare the impact of a plain language decision aid DA to a conventional DA on prostate cancer patients decision making experience and communication with their physician
Methods This study is a randomized controlled trial Men undergoing a prostate biopsy will be recruited at the time of biopsy and complete a baseline interview at pre-biopsy or biopsy appointment Those patients diagnosed with localized prostate cancer will complete two additional interviews at physician visit diagnosis and 7-10 days following physician visit phone survey The treatment discussion between patients and their physician will be audio recorded
Major characteristics All men without a prior history of prostate cancer undergoing a prostate biopsy will be screened for eligibility and enrolled by the study coordinator Additional inclusion criteria include ability to speak English provide informed consent and have a PSA 20 Physicians can refuse to allow a patient participate in the study at the time of biopsy Men will be recruited from 4 VA hospitals Ann Arbor Durham Pittsburgh and San Francisco and randomized to receive one of two decision aid booklets plain language vs conventional
Major variables and sources of data All survey data will be collected from either face-to-face or phone interviews The surveys include measures of literacy numeracy anxiety preference for shared decision making knowledge treatment preferences risk perceptions perception of patient-physician communication and confidence and satisfaction with the decision making process All survey questions were read aloud and responses recorded
Status Recruitment began in September 2008 and concluded in May of 2012
1552 men were approached to participate in the study with 1028 agreeing 1023 completed the Time 1 interview Of the 334 subjects eligible to continue with study activities 285 subjects completed the Time 2 interview biopsy results visit and 244 completed the Time 3 phone interview
Objectives The goal of the study is to compare the impact of a plain language decision aid DA to a conventional DA on prostate cancer patients decision making experience and communication with their physician
Methods This study is a randomized controlled trial Men undergoing a prostate biopsy will be recruited at the time of biopsy and complete a baseline interview at pre-biopsy or biopsy appointment Those patients diagnosed with localized prostate cancer will complete two additional interviews at physician visit diagnosis and 7-10 days following physician visit phone survey The treatment discussion between patients and their physician will be audio recorded
Major characteristics All men without a prior history of prostate cancer undergoing a prostate biopsy will be screened for eligibility and enrolled by the study coordinator Additional inclusion criteria include ability to speak English provide informed consent and have a PSA 20 Physicians can refuse to allow a patient participate in the study at the time of biopsy Men will be recruited from 4 VA hospitals Ann Arbor Durham Pittsburgh and San Francisco and randomized to receive one of two decision aid booklets plain language vs conventional
Major variables and sources of data All survey data will be collected from either face-to-face or phone interviews The surveys include measures of literacy numeracy anxiety preference for shared decision making knowledge treatment preferences risk perceptions perception of patient-physician communication and confidence and satisfaction with the decision making process All survey questions were read aloud and responses recorded
Status Recruitment began in September 2008 and concluded in May of 2012
1552 men were approached to participate in the study with 1028 agreeing 1023 completed the Time 1 interview Of the 334 subjects eligible to continue with study activities 285 subjects completed the Time 2 interview biopsy results visit and 244 completed the Time 3 phone interview
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None