CHESS: Human and Computer Mentors for Prostate Cancer Patients
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00516256
First received: August 14, 2007
Last updated: September 26, 2012
Last verified: September 2012
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Purpose
The aims include:
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.
- To measure potential intervening or mediating processes, so that we can determine how CHESS and the Cancer Information Mentor produce associated QOL benefits.
- 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.
- 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 2014 (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:
- Being within 9 weeks of a primary diagnosis of Stage 1 or Stage 2 prostate cancer
- Being 18 years of age or older
- 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
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 |
| Study First Received: | August 14, 2007 |
| Last Updated: | September 26, 2012 |
| 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 May 23, 2013