NCT00468468

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable

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

April 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

5 years

First QC Date

April 30, 2007

Last Update Submit

February 3, 2016

Conditions

CHESS and Cancer MentorCHESS OnlyMentor OnlyControl (Internet Only)

Keywords

breast cancerInternetcomputersupportinformationeducation

Outcome Measures

Primary Outcomes (1)

  • Patient quality of life

    throughout study

Secondary Outcomes (2)

  • Self efficacy

    throughout study

  • Emotional well being

    throughout study

Study Arms (4)

CHESS Condition

EXPERIMENTAL

Subjects who receive the CHESS (Comprehensive Health Enhancement Support System)

Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor

Mentor Condition

EXPERIMENTAL

Subjects who receive access to a Human Cancer Mentor only

Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor

CHESS + Mentor

EXPERIMENTAL

Subjects who receive the CHESS system plus a Human Cancer Mentor

Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor

Internet Only

NO INTERVENTION

Subjects receive routine care and nothing else

Interventions

CHESS (Comprehensive Health Enhancement Support System) and Human Cancer MentorBEHAVIORAL

computer based education and support

CHESS + MentorCHESS ConditionMentor Condition

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, 06102, United States

Location

M.D. Anderson

Houston, Texas, 77030, United States

Location

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Robert Hawkins, PhD.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2007

First Posted

May 2, 2007

Study Start

September 1, 2003

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

US(3)