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Study Summary
No. 2005-0190:.......Breast......Cindy Carmack Taylor......Behavioral Science
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Study Summary Title
Study Summary
Number:
2005-0190
Study Title:Cancer Communications Systems - Expanding Use/Understanding: Mentor Integration Project
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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 the best way to
provide information, support, and skills-building tools to women with breast
cancer. Researchers will study this through participants' use of a computer
system called CHESS (the Comprehensive Health Enhancement Support System) and
use of human Cancer Mentors.
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Study Objectives / Outcomes
CHESS (Comprehensive Health Enhancement Support System), an innovative internet-based program providing information, social support, and skills training, has been demonstrated to improve the quality of life of cancer patients. This randomized controlled trial will examine the efficacy of a combined intervention using CHESS and a human Cancer Mentor, and compare it against a control condition in which patients are given access to the Internet only (rapidly becoming a de facto standard information care situation), CHESS alone, and the human Cancer Mentor alone. Participants will be followed for 56 weeks to assess quality of life, social support, affect, and cost of providing the interventions. We propose to measure the effect of these conditions on the primary outcome of patient quality of life. Secondary outcomes include social support, affect, and cost of providing the interventions. Additional analyses will examine mediating processes such as satisfaction with the medical system, health self-efficacy (including information competence), knowledge of their own condition, sense of expert watching over them (and trust in those experts) and information overload.
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 study conditions on the primary outcome measure of quality of life.
  • To measure a number of potential intervening processes, so that it can determine how CHESS and the Cancer Mentor produce associated quality-of-life benefits.
  • To determine the costs of providing each study condition.
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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: NCT00468468
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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