Testing the Helpfulness of 2 Decision Aids for Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00432601
First received: February 6, 2007
Last updated: March 7, 2016
Last verified: March 2016
Results First Received: March 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Prostate Cancer
Intervention: Behavioral: type of decision aid

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1 - MCC

Patients will receive Michigan Cancer Consortium decision aid.

type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.

Arm 2 - NCCN

Patients will receive National Comprehensive Cancer Network decision aid.

type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.


Participant Flow for 2 periods

Period 1:   Time 1 to Time 2
    Arm 1 - MCC     Arm 2 - NCCN  
STARTED     510     512  
COMPLETED     141 [1]   144 [1]
NOT COMPLETED     369     368  
[1] There is large drop-off as only one-third of subjects enrolled were eligible to continue the study

Period 2:   Time 2 to Time 3
    Arm 1 - MCC     Arm 2 - NCCN  
STARTED     141     144  
COMPLETED     122     122  
NOT COMPLETED     19     22  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Arm 1

Patients will receive Michigan Cancer Consortium decision aid.

type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.

Arm 2

Patients will receive National Comprehensive Cancer Network decision aid.

type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  510     512     1022  
Age  
[units: years]
Mean (Standard Deviation)
  63.41  (5.86)     63.14  (6.02)     63.28  (5.94)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     510     512     1022  



  Outcome Measures

1.  Primary:   Knowledge   [ Time Frame: Results visit (Time 2 - approximately 7-10 days after Time 1) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Angela Fagerlin
Organization: VA HSRD
phone: 801-587-1694
e-mail: angie.fagerlin@hsc.utah.edu


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00432601     History of Changes
Other Study ID Numbers: IIR 05-283
Study First Received: February 6, 2007
Results First Received: March 19, 2015
Last Updated: March 7, 2016
Health Authority: United States: Federal Government