Prostate CancerNCT00516256
CHESS: Human and Computer Mentors for Prostate Cancer Patients
A study testing CHESS System and Cancer Information Mentor in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- CHESS System and Cancer Information Mentor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jul 2007to 11 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 1. Being under 18 years of age.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hartford Hospital
Hartford, Connecticut, 06102
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
About this study
The aims include:
- To measure the effect of the three study conditions on Quality of Life (QOL).
Read more
- 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- CHESS System, Cancer Information Mentor
- Keywords
- Prostate Cancer, Quality of Life, Cancer Information Mentor, CHESS, the Comprehensive Health Enhancement Support System, Social support, Skill-building tools
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHESS SystemBehavioural
Also called Comprehensive Health Enhancement Support System
Internet-based computer program for 6 months.
Cancer Information MentorBehavioural
Phone calls to the patient for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| CHESS System | Experimental | CHESS System - Internet-based computer program for 6 months. Receives: Behavioral: CHESS System |
| Cancer Information Mentor | Experimental | Cancer Information Mentor - Phone calls to the patient for 6 months. Receives: Behavioral: Cancer Information Mentor |
| CHESS System + Cancer Information Mentor | Experimental | CHESS System + Cancer Information Mentor Receives: Behavioral: CHESS System; Behavioral: Cancer Information Mentor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of three study conditions on Quality of Life
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study start3 Jul 2007
- Primary completion11 May 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Cindy Carmack Taylor, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516256
- Sponsor's protocol ID
- 2007-0254
- Other IDs
- 1R01CA114539-01A2
- Status last verified
- Oct 2018
- First submitted
- 14 Aug 2007
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHESS: Human and Computer Mentors for Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT00516256
- Acronym / sponsor ID
- 2007-0254
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Quality of Life, Cancer Information Mentor, CHESS, the Comprehensive Health Enhancement Support System, Social support, Skill-building tools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Jul 2007 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 15 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHESS System | Experimental | Behavioral: CHESS SystemCHESS System - Internet-based computer program for 6 months. |
| Cancer Information Mentor | Experimental | Behavioral: Cancer Information MentorCancer Information Mentor - Phone calls to the patient for 6 months. |
| CHESS System + Cancer Information Mentor | Experimental | Behavioral: CHESS System, Behavioral: Cancer Information MentorCHESS System + Cancer Information Mentor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- 1. Being under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHESS SystemAlso: Comprehensive Health Enhancement Support SystemInternet-based computer program for 6 months. | Behavioural | CHESS System, CHESS System + Cancer Information Mentor |
| Cancer Information MentorPhone calls to the patient for 6 months. | Behavioural | CHESS System + Cancer Information Mentor, Cancer Information Mentor |
Primary outcome
Effect of three study conditions on Quality of Life
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy Carmack Taylor, PhD principal investigator
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHESS System and Cancer Information Mentor in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of three study conditions on Quality of Life (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.