CHESS: Human and Computer Mentors for Prostate Cancer Patients

October 23, 2018 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CHESS and Cancer Information Mentoring:

Researchers want to learn the best way to improve a man with prostate cancer's knowledge, coping skills, and satisfaction with decision-making and overall quality of life. This study will do this by comparing the following 3 methods of receiving information, social support, and skill training: using the CHESS system for 6 months, talking to a Cancer Information Mentor for 6 months, or using the CHESS system and talking to a Cancer Information Mentor for 6 months.

CHESS is an interactive, internet-based computer program that will provide information, social support, and skill-building techniques. CHESS provides the latest medical, social, and legal information about prostate cancer (such as information on symptoms and treatments). It also provides help in deciding what treatment to choose, advice on where participants can go for help, information on how participants can make the best use of health and human services, and a way for participants to share concerns with cancer information specialists and other survivors of prostate cancer. Participants who take part in the CHESS interactive services will not need to give their names. Participants can talk with other people by sending anonymous (your identity will be unknown) messages through the CHESS computer network.

Cancer Information Mentoring is provided by a person called a "cancer information mentor" that will give quality prostate cancer information and explain medical information and procedures. The cancer information mentor is a certified information specialist trained by the National Cancer Institute (NCI). This mentor will not provide medical advice or mental health counseling.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups. No matter which group you are assigned to, you will be loaned a computer with internet access to use in your own home (unless you have your own computer and would prefer to use it). The computer will be sent to your home, and you will be trained on how to use the computer and the CHESS system.

Participants in Group 1 will have access to the CHESS system. Participants in Group 2 will talk with a cancer information mentor. Participants in Group 3 will have access to the CHESS system and talk with a cancer information mentor.

Study Participation:

CHESS Participants in Group 1 and Group 3 who receive the CHESS internet-based program will have access to information, social support, and skill-building services. The CHESS system will keep a record of how often and for how long each part of CHESS is used. Information will also be gathered about anything you communicate in the CHESS interactions. This information will be used to figure out which parts of CHESS may be most useful. You will be provided a free 1-800 phone number for computer support if you need any help.

Cancer Information Mentoring:

Patients in Group 2 and Group 3 will have access to a cancer information mentor. The mentor will make regular telephone calls to the patient during the study. He will receive 10 calls in total (4 calls the first month, 2 calls the second month, and one call each in Months 3-6). Patients can also call the cancer information mentor whenever they wish during this period. Each call will last as long as the patient needs it to.

For patients in Group 3, the cancer information mentor will communicate with them through CHESS as well as by telephone.

Surveys:

All participants will fill out 5 surveys during this study. The surveys will include questions about health, treatment decisions, knowledge of prostate cancer, and quality of life. You will complete the first survey before you get the computer and again at 2 weeks, 6 weeks, 3 months, and 6 months after getting the computer. The surveys should take about 30 minutes to finish each time.

Length of Study:

This study will last up to a little over 6 months (about 24 weeks).

Up to 327 men and 327 support persons will take part in this multicenter study. Up to 127 participants and 127 support persons will be enrolled at M. D. Anderson.

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHESS System
CHESS System - Internet-based computer program for 6 months.
Behavioral: CHESS System
Internet-based computer program for 6 months.
Other Names:
  • 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
Behavioral: CHESS System
Internet-based computer program for 6 months.
Other Names:
  • Comprehensive Health Enhancement Support System
Behavioral: Cancer Information Mentor
Phone calls to the patient for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of three study conditions on Quality of Life
Time Frame: 6 Months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Cindy Carmack Taylor, PhD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2007

Primary Completion (Actual)

May 11, 2018

Study Completion (Actual)

May 11, 2018

Study Registration Dates

First Submitted

August 14, 2007

First Submitted That Met QC Criteria

August 14, 2007

First Posted (Estimate)

August 15, 2007

Study Record Updates

Last Update Posted (Actual)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0254
  • 1R01CA114539-01A2 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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