- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00468468
Mentor Integration Study
Mentor Integration Project
This study will investigate the benefits of CHESS, a Human Cancer Mentor and the potential additional benefit of combining CHESS and a Cancer Mentor compared to Internet access for women diagnosed with breast cancer. Our goal is to advance interactive cancer communication systems, thus improving quality of life for patients and families facing cancer, especially underserved populations.
Primary Aims:
- Determine if the Internet, CHESS, a Cancer Mentor, or a combination of CHESS and the Cancer Mentor improve quality of life for women with breast cancer
- Determine which of the above conditions is most effective
- Determine which of the above conditions is most cost efficient
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06102
- Hartford Hospital
-
-
Texas
-
Houston, Texas, United States, 77030
- M.D. Anderson
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53706
- University Of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Eligibility for this protocol is as follows:
- All subjects must be within 2 months of their primary breast cancer diagnosis,
- All subjects must be at least 18 years of age,
- All subjects must be able to read and write English at the 6th-grade level
- Not homeless
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CHESS Condition
Subjects who receive the CHESS (Comprehensive Health Enhancement Support System)
|
computer based education and support
|
|
Experimental: Mentor Condition
Subjects who receive access to a Human Cancer Mentor only
|
computer based education and support
|
|
Experimental: CHESS + Mentor
Subjects who receive the CHESS system plus a Human Cancer Mentor
|
computer based education and support
|
|
No Intervention: Internet Only
Subjects receive routine care and nothing else
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient quality of life
Time Frame: throughout study
|
throughout study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self efficacy
Time Frame: throughout study
|
throughout study
|
|
Emotional well being
Time Frame: throughout study
|
throughout study
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Hawkins, PhD., University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2003-192
- 1P50CA09817-01A1 (National Cancer Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.