Component and Couple Analysis of Cancer Communications

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00468741
First received: May 1, 2007
Last updated: February 27, 2014
Last verified: February 2014
  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:


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 ]

Enrollment: 338
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: February 27, 2014
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 September 18, 2014