CHESS: Human and Computer Mentors for Prostate Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00516256
First received: August 14, 2007
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

The aims include:

  1. To measure the effect of the three study conditions on Quality of Life (QOL).

    • CHESS and Cancer Information Mentor will not differ initially (6 weeks) or late in treatment (6 months) in QOL
    • CHESS +Cancer Information Mentor will have the largest impact on QOL (initially and late in treatment) and will be significantly better than either CHESS or Cancer Information Mentor alone.
  2. To measure potential intervening or mediating processes, so that we can determine how CHESS and the Cancer Information Mentor produce associated QOL benefits.
  3. To conduct exploratory use analyses examining which types of CHESS content, sequential patterns of content use, or other characteristics of use behavior are associated with greater pretest-posttest improvements in QOL.
  4. To conduct a secondary analysis exploring whether men whose partners have actively used CHESS do better than those whose partners did not use CHESS.

Condition Intervention
Prostate Cancer
Behavioral: CHESS System
Behavioral: Cancer Information Mentor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: CHESS: Human and Computer Mentors for Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Effect of three study conditions on Quality of Life [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 654
Study Start Date: July 2007
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHESS System
CHESS System - Internet-based computer program for 6 months.
Behavioral: CHESS System
Internet-based computer program for 6 months.
Other Name: Comprehensive Health Enhancement Support System
Experimental: Cancer Information Mentor
Cancer Information Mentor - Phone calls to the patient for 6 months.
Behavioral: Cancer Information Mentor
Phone calls to the patient for 6 months.
Experimental: CHESS System + Cancer Information Mentor
CHESS System + Cancer Information Mentor
Behavioral: CHESS System
Internet-based computer program for 6 months.
Other Name: Comprehensive Health Enhancement Support System
Behavioral: Cancer Information Mentor
Phone calls to the patient for 6 months.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Being within 9 weeks of a primary diagnosis of Stage 1 or Stage 2 prostate cancer
  2. Being 18 years of age or older
  3. Being able to read and write English at the 6th grade level (as shown by an ability to understand the informed consent)

Exclusion Criteria:

1. Being under 18 years of age.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516256

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Texas
UT MD . Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Cindy Carmack Taylor, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00516256     History of Changes
Other Study ID Numbers: 2007-0254, 1 R01 CA114539-01A2
Study First Received: August 14, 2007
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Quality of Life
Cancer Information Mentor
CHESS
the Comprehensive Health Enhancement Support System
Social support
Skill-building tools

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014