CHESS and Cancer MentorNCT00468468
Mentor Integration Study
A study testing CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor in people with CHESS and Cancer Mentor and CHESS Only, run by University of Wisconsin, Madison at 3 sites in United States.
Trial summary
Mentor Integration Project This study will investigate the benefits of CHESS, a Human Cancer Mentor and the potential additional benefit of combining CHESS and a Cancer Mentor compared to Internet access for women diagnosed with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- CHESS and Cancer Mentor, CHESS Only, Mentor Only
- What is being tested?
- CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2003to Sep 2008
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility for this protocol is as follows:
- All subjects must be within 2 months of their primary breast cancer diagnosis,
- All subjects must be at least 18 years of age,
- All subjects must be able to read and write English at the 6th-grade level
- Not homeless
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hartford Hospital
Hartford, Connecticut, 06102
M.D. Anderson
Houston, Texas, 77030
University of Wisconsin
Madison, Wisconsin, 53706
About this study
Mentor Integration Project
This study will investigate the benefits of CHESS, a Human Cancer Mentor and the potential additional benefit of combining CHESS and a Cancer Mentor compared to Internet access for women diagnosed with breast cancer. Our goal is to advance interactive cancer communication systems, thus improving quality of life for patients and families facing cancer, especially underserved populations.
Primary Aims:
- Determine if the Internet, CHESS, a Cancer Mentor, or a combination of CHESS and the Cancer Mentor improve quality of life for women with breast cancer
- Determine which of the above conditions is most effective
- Determine which of the above conditions is most cost efficient
- Being tested
- CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor
- Keywords
- breast cancer, Internet, computer, support, information, education
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHESS (Comprehensive Health Enhancement Support System) and Human Cancer MentorBehavioural
computer based education and support
| Study group | Role | What they receive |
|---|---|---|
| CHESS Condition | Experimental | Subjects who receive the CHESS (Comprehensive Health Enhancement Support System) Receives: Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor |
| Mentor Condition | Experimental | Subjects who receive access to a Human Cancer Mentor only Receives: Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor |
| CHESS + Mentor | Experimental | Subjects who receive the CHESS system plus a Human Cancer Mentor Receives: Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer Mentor |
| Internet Only | No intervention | Subjects receive routine care and nothing else |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient quality of life
Measured: throughout study
Secondary outcomes (2)
Self efficacy
Measured: throughout study
Emotional well being
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2007 (estimated)
- Study startSep 2003
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHESS and Cancer MentorStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert Hawkins, PhD., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468468
- Sponsor's protocol ID
- 2003-192
- Other IDs
- 1P50CA09817-01A1
- Status last verified
- Feb 2016
- First submitted
- 30 Apr 2007
- Last updated
- 5 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mentor Integration Study
- ClinicalTrials.gov ID
- NCT00468468
- Acronym / sponsor ID
- 2003-192
- Keywords
- breast cancer, Internet, computer, support, information, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 2 May 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.
Mentor Integration Project
This study will investigate the benefits of CHESS, a Human Cancer Mentor and the potential additional benefit of combining CHESS and a Cancer Mentor compared to Internet access for women diagnosed with breast cancer. Our goal is to advance interactive cancer communication systems, thus improving quality of life for patients and families facing cancer, especially underserved populations.
Primary Aims:
- Determine if the Internet, CHESS, a Cancer Mentor, or a combination of CHESS and the Cancer Mentor improve quality of life for women with breast cancer
- Determine which of the above conditions is most effective
- Determine which of the above conditions is most cost efficient
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CHESS Condition | Experimental | Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer MentorSubjects who receive the CHESS (Comprehensive Health Enhancement Support System) |
| Mentor Condition | Experimental | Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer MentorSubjects who receive access to a Human Cancer Mentor only |
| CHESS + Mentor | Experimental | Behavioral: CHESS (Comprehensive Health Enhancement Support System) and Human Cancer MentorSubjects who receive the CHESS system plus a Human Cancer Mentor |
| Internet Only | No intervention | –Subjects receive routine care and nothing else |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All subjects must be within 2 months of their primary breast cancer diagnosis,
- All subjects must be at least 18 years of age,
- All subjects must be able to read and write English at the 6th-grade level
- Not homeless
Key exclusion criteria (0 listed)
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 (Comprehensive Health Enhancement Support System) and Human Cancer Mentorcomputer based education and support | Behavioural | CHESS + Mentor, CHESS Condition, Mentor Condition |
Primary outcome
Patient quality of life
Time frame: throughout study
2 secondary outcomes
Self efficacy
Time frame: throughout study
Emotional well being
Time frame: throughout study
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 5 Feb 2016.
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.
Robert Hawkins, PhD. principal investigator
University of Wisconsin, Madison
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 (Comprehensive Health Enhancement Support System) and Human Cancer Mentor in people with CHESS and Cancer Mentor and CHESS Only, run by University of Wisconsin, Madison 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 5 inclusion and 0 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 5 Feb 2016. 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?
Patient quality of life (time frame: throughout study). 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 5 Feb 2016.