Component and Couple Analysis of Cancer Communications

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00468741
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 338
• Locations: 3
• Arms: 4
• Duration (Months): 129
• Patients Per Site: 112.7
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Behavioral: CHESS (Comprehensive Health Enhancement Support System); Behavioral: CHESS; Behavioral: CHESS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 338 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Component and Couple Analysis of Cancer Communications
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Patient Quality of Life [monthly]

Secondary Outcome Measures

1. Emotional Well-being [monthly]

2. Self Efficacy [monthly]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hartford Hospital	Hartford	Connecticut	United States
2	M. D. Anderson	Houston	Texas	United States
3	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Wisconsin Carbone Cancer Center

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00468741
• Other Study ID Numbers: 2003-193; 1P50CA09817-01A1; CC04318; 2003-193; A534253; SMPH/MEDICINE/MEDICINE
• First Posted: May 3, 2007
• Last Update Posted: Nov 18, 2019
• Last Verified: Apr 1, 2016

• 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

Study Results

No Results Posted as of Nov 18, 2019