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Component and Couple Analysis of Cancer Communications

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00468741
First received: May 1, 2007
Last updated: November 28, 2011
Last verified: November 2011
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Component and Couple Analysis of Cancer Communications

Resource links provided by NLM:

U.S. FDA Resources

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: December 2014
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
subjects receive internet access and computer
Experimental: 2
CHESS informational services only
 Behavioral: CHESS
informational services of CHESS available to subject
Experimental: 3
CHESS social support and informational services
 Behavioral: CHESS
CHESS informational services and social support available to subject
Experimental: 4
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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00468741     History of Changes
Other Study ID Numbers: 2003-193, 1P50CA09817-01A1
Study First Received: May 1, 2007
Last Updated: November 28, 2011
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013