Component and Couple Analysis of Cancer Communications
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHESS (Comprehensive Health Enhancement Support System)
CHESS
CHESS
Sponsored by

About this trial
This is an interventional other trial for Breast Cancer focused on measuring Breast Cancer, Internet, Computer, Support, Information, Education, Control Group: Usual care and Internet access, CHESS Information Services only, CHESS Social Support & Information Services, CHESS Information, Social Support & Skills Services
Eligibility Criteria
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
Sites / Locations
- Hartford Hospital
- M. D. Anderson
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
subjects receive internet access and computer
CHESS informational services only
CHESS social support and informational services
Full CHESS
Outcomes
Primary Outcome Measures
Patient Quality of Life
Secondary Outcome Measures
Emotional Well-being
Self Efficacy
Full Information
NCT ID
NCT00468741
First Posted
May 1, 2007
Last Updated
November 14, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00468741
Brief Title
Component and Couple Analysis of Cancer Communications
Official Title
Component and Couple Analysis of Cancer Communications
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Component and Couple Analysis of Cancer Communication
CHESS, the Comprehensive Health Enhancement Support System is an innovative technology that provides information, social support and skills training to women with breast cancer. Previous CHESS clinical trials found improved patient outcomes but little is known about what services in CHESS produce those results. This study will examine whether breast cancer patient outcomes change when conceptually distinct CHESS services (information, social support, and skills training) are systematically added to a patients treatment resources.
Primary Aims:
Determine the relative efficacies of different types of cancer communication treatments when they are presented alone or in combination
Determine routes or processes via which these elements work
Determine for whom the different treatment types work best.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Internet, Computer, Support, Information, Education, Control Group: Usual care and Internet access, CHESS Information Services only, CHESS Social Support & Information Services, CHESS Information, Social Support & Skills Services
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
338 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
subjects receive internet access and computer
Arm Title
2
Arm Type
Experimental
Arm Description
CHESS informational services only
Arm Title
3
Arm Type
Experimental
Arm Description
CHESS social support and informational services
Arm Title
4
Arm Type
Experimental
Arm Description
Full CHESS
Intervention Type
Behavioral
Intervention Name(s)
CHESS (Comprehensive Health Enhancement Support System)
Intervention Description
Full CHESS for subject use
Intervention Type
Behavioral
Intervention Name(s)
CHESS
Intervention Description
informational services of CHESS available to subject
Intervention Type
Behavioral
Intervention Name(s)
CHESS
Intervention Description
CHESS informational services and social support available to subject
Primary Outcome Measure Information:
Title
Patient Quality of Life
Time Frame
monthly
Secondary Outcome Measure Information:
Title
Emotional Well-being
Time Frame
monthly
Title
Self Efficacy
Time Frame
monthly
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Baker, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
M. D. Anderson
City
Houston
State/Province
Texas
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States
12. IPD Sharing Statement
Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center
Learn more about this trial
Component and Couple Analysis of Cancer Communications
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