Breast CancerNCT00468741
Component and Couple Analysis of Cancer Communications
A study testing CHESS (Comprehensive Health Enhancement Support System) and CHESS in people with Breast Cancer, run by University of Wisconsin, Madison at 3 sites in United States.
Trial summary
Component and Couple Analysis of Cancer Communication CHESS, the Comprehensive Health Enhancement Support System is an innovative technology that provides information, social support and skills training to women with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CHESS (Comprehensive Health Enhancement Support System) and CHESS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2003to Jun 2014
- 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
M. D. Anderson
Houston, Texas
University of Wisconsin
Madison, Wisconsin, 53706
About this study
Component and Couple Analysis of Cancer Communication
CHESS, the Comprehensive Health Enhancement Support System is an innovative technology that provides information, social support and skills training to women with breast cancer. Previous CHESS clinical trials found improved patient outcomes but little is known about what services in CHESS produce those results. This study will examine whether breast cancer patient outcomes change when conceptually distinct CHESS services (information, social support, and skills training) are systematically added to a patients treatment resources.
Read more
Primary Aims:
- Determine the relative efficacies of different types of cancer communication treatments when they are presented alone or in combination
- Determine routes or processes via which these elements work
- Determine for whom the different treatment types work best.
- Conditions
- Breast Cancer
- Being tested
- CHESS (Comprehensive Health Enhancement Support System), CHESS
- Keywords
- Breast Cancer, Internet, Computer, Support, Information, Education, Control Group: Usual care and Internet access, CHESS Information Services only, CHESS Social Support & Information Services, CHESS Information, Social Support & Skills Services
- 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)Behavioural
Full CHESS for subject use
CHESSBehavioural
informational services of CHESS available to subject
CHESSBehavioural
CHESS informational services and social support available to subject
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | subjects receive internet access and computer |
| 2 | Experimental | CHESS informational services only Receives: Behavioral: CHESS |
| 3 | Experimental | CHESS social support and informational services Receives: Behavioral: CHESS |
| 4 | Experimental | Full CHESS Receives: Behavioral: CHESS (Comprehensive Health Enhancement Support System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Quality of Life
Measured: monthly
Secondary outcomes (2)
Emotional Well-being
Measured: monthly
Self Efficacy
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study startSep 2003
- Primary completionDec 2008
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 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
- Timothy Baker, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468741
- Sponsor's protocol ID
- 2003-193
- Other IDs
- 1P50CA09817-01A1, CC04318, 2003-193, A534253, SMPH/MEDICINE/MEDICINE
- Status last verified
- Apr 2016
- First submitted
- 1 May 2007
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Component and Couple Analysis of Cancer Communications
- ClinicalTrials.gov ID
- NCT00468741
- Acronym / sponsor ID
- 2003-193
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Internet, Computer, Support, Information, Education, Control Group: Usual care and Internet access, CHESS Information Services only
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2003
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 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.
Component and Couple Analysis of Cancer Communication
CHESS, the Comprehensive Health Enhancement Support System is an innovative technology that provides information, social support and skills training to women with breast cancer. Previous CHESS clinical trials found improved patient outcomes but little is known about what services in CHESS produce those results. This study will examine whether breast cancer patient outcomes change when conceptually distinct CHESS services (information, social support, and skills training) are systematically added to a patients treatment resources.
Primary Aims:
- Determine the relative efficacies of different types of cancer communication treatments when they are presented alone or in combination
- Determine routes or processes via which these elements work
- Determine for whom the different treatment types work best.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –subjects receive internet access and computer |
| 2 | Experimental | Behavioral: CHESSCHESS informational services only |
| 3 | Experimental | Behavioral: CHESSCHESS social support and informational services |
| 4 | Experimental | Behavioral: CHESS (Comprehensive Health Enhancement Support System)Full CHESS |
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)Full CHESS for subject use | Behavioural | 4 |
| CHESSinformational services of CHESS available to subject | Behavioural | 2 |
| CHESSCHESS informational services and social support available to subject | Behavioural | 3 |
Primary outcome
Patient Quality of Life
Time frame: monthly
2 secondary outcomes
Emotional Well-being
Time frame: monthly
Self Efficacy
Time frame: monthly
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 18 Nov 2019.
- University of Wisconsin Carbone Cancer CenterLink 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.
Timothy Baker, 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 CHESS in people with Breast Cancer, 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 18 Nov 2019. 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: monthly). 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 18 Nov 2019.