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CHESS: Human and Computer Mentors for Prostate Cancer Patients

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHESS System
Cancer Information Mentor
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate Cancer, Quality of Life, Cancer Information Mentor, CHESS, the Comprehensive Health Enhancement Support System, Social support, Skill-building tools

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hartford Hospital
  • University of Texas MD Anderson Cancer Center
  • University of Wisconsin Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CHESS System

Cancer Information Mentor

CHESS System + Cancer Information Mentor

Arm Description

CHESS System - Internet-based computer program for 6 months.

Cancer Information Mentor - Phone calls to the patient for 6 months.

CHESS System + Cancer Information Mentor

Outcomes

Primary Outcome Measures

Effect of three study conditions on Quality of Life

Secondary Outcome Measures

Full Information

First Posted
August 14, 2007
Last Updated
October 23, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00516256
Brief Title
CHESS: Human and Computer Mentors for Prostate Cancer Patients
Official Title
CHESS: Human and Computer Mentors for Prostate Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 3, 2007 (Actual)
Primary Completion Date
May 11, 2018 (Actual)
Study Completion Date
May 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Quality of Life, Cancer Information Mentor, CHESS, the Comprehensive Health Enhancement Support System, Social support, Skill-building tools

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHESS System
Arm Type
Experimental
Arm Description
CHESS System - Internet-based computer program for 6 months.
Arm Title
Cancer Information Mentor
Arm Type
Experimental
Arm Description
Cancer Information Mentor - Phone calls to the patient for 6 months.
Arm Title
CHESS System + Cancer Information Mentor
Arm Type
Experimental
Arm Description
CHESS System + Cancer Information Mentor
Intervention Type
Behavioral
Intervention Name(s)
CHESS System
Other Intervention Name(s)
Comprehensive Health Enhancement Support System
Intervention Description
Internet-based computer program for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Cancer Information Mentor
Intervention Description
Phone calls to the patient for 6 months.
Primary Outcome Measure Information:
Title
Effect of three study conditions on Quality of Life
Time Frame
6 Months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy Carmack Taylor, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

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CHESS: Human and Computer Mentors for Prostate Cancer Patients

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