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Study Summary
No. 2007-0254:.......Prostate......Cindy Carmack Taylor......Behavioral Science
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Study Summary Title
Study Summary
Number:
2007-0254
Study Title:Human and Computer Mentors for Prostate Cancer Patients
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Physician New Patient Referral
Name:Cindy Carmack TaylorPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Behavioral ScienceReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3582
Contact us about clinical trials
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General Information
Disease Group:ProstateSupported By:National Cancer Institute
Phase of Study:N/AReturn
Visit:
No visits are required as this psychosocial intervention is delivered over the
internet, which participants will access from their homes.
Treatment
Agents:
PsychosocialHome Care:Participants will access their assigned study conditions on the internet using
either their own home computer or one provided to them by the study.
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this research study is to try to find an effective way to provide
information, social support, and skill-building tools to men with prostate
cancer. Researchers will study participants' use of the Comprehensive Health
Enhancement Support System (CHESS) and "cancer information mentoring" to see if
these may be effective ways to provide information, social support, and
skill-building tools to these men.
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Study Objectives / Outcomes
Prostate cancer patients and their families face the problems typical of all cancers as well as some that make their situation unique. Besides how the disease and its treatments affect quality of life (QOL) for patients and their partners, the open-ended uncertainty can further degrade QOL. Reducing that degradation and speeding the process of regaining control requires multiple complimentary resources: information about treatment options and side effects, skills for dealing with information and clinical systems, access to experiences and support of others in similar situations, and help dealing with the disease as a couple instead of as an individual. A web-based system of information, support and tools to aid prostate cancer patients known as CHESS (the Comprehensive Health Enhancement Support System) has been created. In addition, a human Cancer Information Mentor (based on the CIS Information Specialist role) may enhance the efficacy of CHESS by providing a continuing information-supportive relationship with a patient.
Newly-diagnosed patients will be randomly assigned to one of three conditions, all containing Internet access and lasting 6 months: 1) access to a human Cancer Information Mentor, 2) access to the full CHESS system and 3) CHESS and Mentor combined. We will test the relative efficacy of CHESS and a human Cancer Information Mentor against each other, and test the benefits of the two combined against the benefits of either alone. A total of 327 prostate cancer patients will be enrolled in this multi-site study: 105 will be recruited from University of Wisconsin Comprehensive Cancer Center (UWCCC), with 84 participants completing the study (20% drop out rate); 95 will be recruited from Hartford Hospital with 76 completing study; and 127 will be recruited from M.D. Anderson with 102 completing study. Participants will complete questionnaires prior to the intervention (baseline), 2, 6, 12, and 24 weeks post-baseline. Further, partners who wish to use CHESS and who provide their consent will also be enrolled. The aims include:
1) To measure the effect of the three study conditions on QOL.
· CHESS and Cancer Information Mentor will not differ initially (6 weeks) or late in treatment (6 months) in QOL
· CHESS +Cancer Information Mentor will have the largest impact on QOL (initially and late in treatment) and will be significantly better than either CHESS or Cancer Information Mentor alone.
2) To measure potential intervening or mediating processes, so that we can determine how CHESS and the Cancer Information Mentor produce associated QOL benefits.
3) To conduct exploratory use analyses examining which types of CHESS content, sequential patterns of content use, or other characteristics of use behavior are associated with greater pretest-posttest improvements in QOL.
4) To conduct a secondary analysis exploring whether men whose partners have actively used CHESS do better than those whose partners did not use CHESS.
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Study Status Information
Study Activation / Registration Date:07/03/2007
IRB Review and Approval Date:07/03/2007
Study Type:Other
Recruitment Status:Closed
Projected Accrual:654
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) being within 9 weeks of a primary diagnosis of Stage 1 or Stage 2 prostate cancer

2) being 18 years of age or older

3) being able to read and write English at the 6th grade level (as shown by an ability to understand the informed consent)

Exclusion Criteria:N/A

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Links
Registration Number: NCT00516256
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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