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Study Summary
No. 2005-0189:.......Breast......Cindy Carmack Taylor......Behavioral Science
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Study Summary Title
Study Summary
Number:
2005-0189
Study Title:Components and Couple Analysis of Cancer Communications
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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:BreastSupported By:N/A
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:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this psychosocial research study is to find out if women who are
newly diagnosed with breast cancer are helped by getting information, support,
and decision-making tools through a computer system called CHESS (the
Comprehensive Health Enhancement Support System).
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Study Objectives / Outcomes
CHESS (Comprehensive Health Enhancement Support System) is an innovative internet-based program demonstrated to improve the quality of life of cancer patients. This randomized controlled trial will examine whether cancer patient outcomes change as different types of conceptually distinct CHESS services (information, social support, and skills training) are systematically added to a patient's treatment resources. Analyses will identify specific CHESS effects responsible for improvement on the primary outcome of patient quality of life. Newly-diagnosed breast cancer patients will be randomly assigned to four intervention conditions: a control group receiving usual care plus internet access; CHESS providing information only (Inf); CHESS providing social support and information (InfS); and CHESS providing information, social support and skills training (InfSS). This research will help reveal the types of treatments that are most helpful to cancer patients and how they work.
Participants in this multi-site study will be recruited from The University of Wisconsin Comprehensive Cancer Center; Hartford Hospital; and The University of Texas M.D. Anderson Cancer Center. This study is one of three projects on a Center of Excellence in Cancer Communication Research grant, awarded to researchers at the University of Wisconsin (David Gustafson, Ph.D., Principal Investigator). The aims include:
  • To examine differences among the intervention components on the primary outcome measure of quality of life. To understand processes, we will also look for differences in intervention-specific, targeted outcomes such as variables reflecting affect and depressive symptoms, health services use and satisfaction, information competence, relationship quality, perceived support, and coping.
  • To examine differences among the intervention components on the secondary outcomes of knowledge, social support, relationship skills, and coping skills.
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Study Status Information
Study Activation / Registration Date:10/13/2005
IRB Review and Approval Date:04/20/2005
Study Type:Not Applicable
Recruitment Status:Closed
Projected Accrual:450 patients + 450 support persons
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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) Eligibility for patient - being within 2 months of a primary diagnosis of breast cancer, regardless of stage

2) Eligibility for patient - being 18 years of age or older

3) Eligibility for patient - being female

4) Eligibility for patient - being able to read and write English at the 6th grade (as shown by an ability to understand the informed consent) level

5) Eligibility for support persons: · being identified as a support person to a women diagnosed with breast cancer

6) Eligibility for support persons: · being able to read and write English at the 6th grade (as shown by an ability to understand the informed consent) level.

Exclusion Criteria:1) Eligibility for patient - being homeless

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Links
Registration Number: NCT00468741
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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