Component and Couple Analysis of Cancer Communications - Full Text View

Sponsors and Collaborators:	University of Wisconsin, Madison National Cancer Institute (NCI)
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00468741

Purpose

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.

Condition	Intervention
Breast Cancer	Behavioral: CHESS (Comprehensive Health Enhancement Support System) Behavioral: CHESS

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Component and Couple Analysis of Cancer Communications

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Patient Quality of Life [ Time Frame: monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Emotional Well-being [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
Self Efficacy [ Time Frame: monthly ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	September 2003
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention subjects receive internet access and computer
2: Experimental CHESS informational services only	Behavioral: CHESS informational services of CHESS available to subject
3: Experimental CHESS social support and informational services	Behavioral: CHESS CHESS informational services and social support available to subject
4: Experimental Full CHESS	Behavioral: CHESS (Comprehensive Health Enhancement Support System) Full CHESS for subject use

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468741

Locations

United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States
United States, Texas
M. D. Anderson
Houston, Texas, United States
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53706

Sponsors and Collaborators

University of Wisconsin, Madison

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Timothy Baker, PhD

University of Wisconsin, Madison

More Information

Responsible Party:	University of Wisconsin ( Timothy Baker, PhD )
Study ID Numbers:	2003-193, 1P50CA09817-01A1
Study First Received:	May 1, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00468741
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

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

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009