Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196781
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2005-09-12
Brief Title:
Treatment Decision Making in Early-Stage Prostate Cancer
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Treatment Decision Making in Early-Stage Prostate Cancer Evaluation of Computer Based Patient Education and an Interactive Decision Aid
Status:
COMPLETED
Status Verified Date:
2010-01
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:
We plan to test the effectiveness of a recently developed computer-based program that is designed to improve patient knowledge about prostate cancer treatments It is also designed to help men clarify their values using a computer-based decision aid A decision aid gives patients tools to help them understand their own values and how these values may be related to their choice of different forms of therapy for prostate cancer In order to test the effectiveness of the decision aid men will be assigned on a chance basis to receive either 1 the computer program that includes the information about prostate cancer treatments alone or 2 the computer program that contains both the information and the decision aid We expect that men in decision aid group will be more active in their treatment decision and will have improved knowledge quality of life and satisfaction with the treatment decision relative to men who only receive the information
Detailed Description:
Background There is a controversy in the medical community surrounding the utility of treatment options for clinically localized prostate cancer Although several options are available for management of localized prostate cancer no option is clearly superior to others The main therapeutic options for localized prostate cancer include radical prostatectomy RP radiation therapy RT external beam radiation or brachytherapy and expectant management EM or watchful waiting The American Urological Association after a structured review of the available literature concluded that there is insufficient evidence to clearly recommend RP RT or EM They recommended that factors such as life expectancy current health and patient preference for therapeutic options be considered in the treatment decision Since the survival benefits of the different management strategies are as of yet uncertain and mens preferences for outcomes of therapy may influence the decision regarding management choice men should be informed of potential outcomes and should be encouraged to examine their own values in deciding upon a management strategy for their prostate cancer
Objective The primary goal is to evaluate a method of patient education that is designed to provide treatment-related information and to help men clarify their preferences and values via a recently developed computer-based decision aid We expect that men randomized to the decision aid condition will be more active in their treatment decision and will have improved patient outcomes relative to men assigned to the Information only condition
Specific Aims The specific aims are 1 To evaluate the relative impact of providing newly diagnosed patients with computer-based prostate cancer treatment information vs providing patients with the information plus an interactive decision-aid on a shared decision-making practices and b patient outcomes decisional satisfaction quality of life knowledge 2 To explore the mechanisms by which the decision aid impacts on SDM and patient outcomes and 3 To identify men who are most and least likely to benefit from the education plus decision-aid intervention
Study Design Men will be accrued at the time of their biopsy and those with a positive biopsy result will receive the intervention following notification of the diagnosis but prior to their initial meeting with the urologist in which treatment options are discussed Participants will be followed at one six and twelve months post-intervention The primary outcomes include patient outcomes knowledge quality of life and decisional satisfaction and shared decision making SDM practices
Relevance In many areas of medicine including treatment of localized prostate cancer there has been a rapid expansion of research that has resulted in a growing number of diagnostic and treatment options that are available to physicians and patients In many cases there are several effective and viable treatment options but randomized clinical trials assessing treatment effectiveness have not yet been completed Although the availability of different options will undoubtedly be beneficial in the long run at present it creates a difficult decision for individuals and physicians who are faced with the choices for which no best answer is known The proposed study is designed to assist patient through this decision by providing information and helping them to consider their values
Objective The primary goal is to evaluate a method of patient education that is designed to provide treatment-related information and to help men clarify their preferences and values via a recently developed computer-based decision aid We expect that men randomized to the decision aid condition will be more active in their treatment decision and will have improved patient outcomes relative to men assigned to the Information only condition
Specific Aims The specific aims are 1 To evaluate the relative impact of providing newly diagnosed patients with computer-based prostate cancer treatment information vs providing patients with the information plus an interactive decision-aid on a shared decision-making practices and b patient outcomes decisional satisfaction quality of life knowledge 2 To explore the mechanisms by which the decision aid impacts on SDM and patient outcomes and 3 To identify men who are most and least likely to benefit from the education plus decision-aid intervention
Study Design Men will be accrued at the time of their biopsy and those with a positive biopsy result will receive the intervention following notification of the diagnosis but prior to their initial meeting with the urologist in which treatment options are discussed Participants will be followed at one six and twelve months post-intervention The primary outcomes include patient outcomes knowledge quality of life and decisional satisfaction and shared decision making SDM practices
Relevance In many areas of medicine including treatment of localized prostate cancer there has been a rapid expansion of research that has resulted in a growing number of diagnostic and treatment options that are available to physicians and patients In many cases there are several effective and viable treatment options but randomized clinical trials assessing treatment effectiveness have not yet been completed Although the availability of different options will undoubtedly be beneficial in the long run at present it creates a difficult decision for individuals and physicians who are faced with the choices for which no best answer is known The proposed study is designed to assist patient through this decision by providing information and helping them to consider their values
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