NCT00468741

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 18, 2019

Status Verified

April 1, 2016

Enrollment Period

5.3 years

First QC Date

May 1, 2007

Last Update Submit

November 14, 2019

Conditions

Breast Cancer

Keywords

Breast CancerInternetComputerSupportInformationEducationControl Group: Usual care and Internet accessCHESS Information Services onlyCHESS Social Support & Information ServicesCHESS Information, Social Support & Skills Services

Outcome Measures

Primary Outcomes (1)

  • Patient Quality of Life

    monthly

Secondary Outcomes (2)

  • Emotional Well-being

    monthly

  • Self Efficacy

    monthly

Study Arms (4)

1

NO INTERVENTION

subjects receive internet access and computer

2

EXPERIMENTAL

CHESS informational services only

Behavioral: CHESS

3

EXPERIMENTAL

CHESS social support and informational services

Behavioral: CHESS

4

EXPERIMENTAL

Full CHESS

Behavioral: CHESS (Comprehensive Health Enhancement Support System)

Interventions

CHESS (Comprehensive Health Enhancement Support System)BEHAVIORAL

Full CHESS for subject use

4
CHESSBEHAVIORAL

informational services of CHESS available to subject

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hartford Hospital

Hartford, Connecticut, United States

Location

M. D. Anderson

Houston, Texas, United States

Location

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Timothy Baker, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2007

First Posted

May 3, 2007

Study Start

September 1, 2003

Primary Completion

December 1, 2008

Study Completion

June 1, 2014

Last Updated

November 18, 2019

Record last verified: 2016-04

Locations

US(3)