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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
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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 
Overall Participants Analyzed 
[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