Component and Couple Analysis of Cancer Communications

November 14, 2019 updated by: University of Wisconsin, Madison

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

338

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
Behavioral: CHESS
CHESS informational services and social support available to subject
EXPERIMENTAL: 3
CHESS social support and informational services
Behavioral: CHESS
informational services of CHESS available to subject
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Quality of Life
Time Frame: monthly
monthly

Secondary Outcome Measures

Outcome Measure
Time Frame
Emotional Well-being
Time Frame: monthly
monthly
Self Efficacy
Time Frame: monthly
monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Timothy Baker, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

May 1, 2007

First Submitted That Met QC Criteria

May 2, 2007

First Posted (ESTIMATE)

May 3, 2007

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-193 (OTHER: Institutional Review Board)
  • A534253 (Other Identifier: UW- Madison)
  • SMPH/MEDICINE/MEDICINE (Other Identifier: UW Madison)
  • 1P50CA09817-01A1 (National Cancer Institute)
  • CC04318 (OTHER: University of Wisconsin, Madison)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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