Mentor Integration Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00468468
First received: April 30, 2007
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

Mentor Integration Project

This study will investigate the benefits of CHESS, a Human Cancer Mentor and the potential additional benefit of combining CHESS and a Cancer Mentor compared to Internet access for women diagnosed with breast cancer. Our goal is to advance interactive cancer communication systems, thus improving quality of life for patients and families facing cancer, especially underserved populations.

Primary Aims:

  • Determine if the Internet, CHESS, a Cancer Mentor, or a combination of CHESS and the Cancer Mentor improve quality of life for women with breast cancer
  • Determine which of the above conditions is most effective
  • Determine which of the above conditions is most cost efficient

Condition Intervention
CHESS and Cancer Mentor
CHESS Only
Mentor Only
Control (Internet Only)
Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Mentor Integration Study

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Patient quality of life [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self efficacy [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Emotional well being [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
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
Experimental: CHESS Condition
Subjects who receive the CHESS (Comprehensive Health Enhancement Support System)
Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor
computer based education and support
Experimental: Mentor Condition
Subjects who receive access to a Human Cancer Mentor only
Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor
computer based education and support
Experimental: CHESS + Mentor
Subjects who receive the CHESS system plus a Human Cancer Mentor
Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor
computer based education and support
No Intervention: Internet Only
Subjects receive routine care and nothing else

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468468

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Texas
M.D. Anderson
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Robert Hawkins, PhD. University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00468468     History of Changes
Other Study ID Numbers: 2003-192, 1P50CA09817-01A1
Study First Received: April 30, 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

ClinicalTrials.gov processed this record on April 17, 2014