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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
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
May 1, 2007
Last Updated
November 14, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
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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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