Primary Breast CancerNCT01033162
Effectiveness of the CHESS eHealth Cancer Support Intervention in Population-based Care
A study testing Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.) in people with Primary Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The study's aim is to provide information about the clinical and business cases for comprehensive interactive cancer communication systems (ICCS) in the context of real world use for cancer care. This study will be conducted within the Kaiser Permanente Northwest (KPNW) healthcare system. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Breast Cancer
- What is being tested?
- Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Aug 2013
- 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
- All subjects must be within 2 months of their primary breast cancer diagnosis,
- All subjects must be at least 18 years of age
Who cannot join
- Illiterate
- Homeless
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Technology to Enhance Cancer Communication and Improve Clinical Outcome: Effectiveness of the CHESS Ehealth Cancer Support Intervention in Population-Based Care Study
The study's aim is to provide information about the clinical and business cases for comprehensive interactive cancer communication systems (ICCS) in the context of real world use for cancer care.
This study will be conducted within the Kaiser Permanente Northwest (KPNW) healthcare system. Outcomes for this study include amount of ICCS use and women's ratings of cancer information competence, perceived social support, and emotional well being. Secondary outcomes will include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare visits.
- Conditions
- Primary Breast Cancer
- Being tested
- Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.)Behavioural
Half of the participating women will be randomly assigned to use an informative but static website (Basic ICCS), and half will be offered a fully interactive CHESS (Enhanced ICCS + the Basic ICCS). Study outcome data will be gathered from patients, clinicians, and the healthcare system (i.e., from the electronic medical record: EMR) for at least 8 months after study entry. We propose that the Enhanced ICCS relative to the Basic ICCS, will:
- Improve patients' sense of cancer information competence (perceived ability to obtain and use relevant information)
- Reduce patients' negative affect and increase their emotional well being
- Improve patients' sense of social support
- Improve patients' health self-efficacy
- Improve patients' ratings of experience with cancer specialty care services
- Improve patients' health related quality of life (HRQL)
- Improve clinicians' ratings of quality of patient contacts
- Reduce healthcare utilization and costs (obtained via the EMR)
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | A group using a Basic ICCS provided by KPNW |
| Intervention | Experimental | A group using an enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.) Receives: Behavioral: Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of ICCS use and women's ratings of cancer information competence, perceived social support, and emotional well being. Secondary outcomes will include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare visits.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 368 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, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033162
- Sponsor's protocol ID
- H-2008-0222
- Other IDs
- 5P50CA095817, XP08323, NCI-2013-01101, A534253, SMPH/MEDICINE/MEDICINE*G
- Status last verified
- Feb 2016
- First submitted
- 14 Dec 2009
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
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
- Using Technology to Enhance Cancer Communication and Improve Clinical Outcome: Effectiveness of the CHESS Ehealth Cancer Support Intervention in Population-Based Care Study
- ClinicalTrials.gov ID
- NCT01033162
- Acronym / sponsor ID
- H-2008-0222
- Conditions
- Primary Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Dec 2009 (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 study's aim is to provide information about the clinical and business cases for comprehensive interactive cancer communication systems (ICCS) in the context of real world use for cancer care.
This study will be conducted within the Kaiser Permanente Northwest (KPNW) healthcare system. Outcomes for this study include amount of ICCS use and women's ratings of cancer information competence, perceived social support, and emotional well being. Secondary outcomes will include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare visits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –A group using a Basic ICCS provided by KPNW |
| Intervention | Experimental | Behavioral: Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.)A group using an enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All subjects must be within 2 months of their primary breast cancer diagnosis,
- All subjects must be at least 18 years of age
Key exclusion criteria (2 listed)
- Illiterate
- Homeless
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 |
|---|---|---|
| Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.)Half of the participating women will be randomly assigned to use an informative but static website (Basic ICCS), and half will be offered a fully interactive CHESS (Enhanced ICCS + the Basic ICCS). Study outcome data will be gathered from patients, clinicians, and the healthcare system (i.e., from the electronic medical record: EMR) for at least 8 months after study entry. We propose that the Enhanced ICCS relative to the Basic ICCS, will: * Improve patients' sense of cancer information competence (perceived ability to obtain and use relevant information) * Reduce patients' negative affect and increase their emotional well being * Improve patients' sense of social support * Improve patients' health self-efficacy * Improve patients' ratings of experience with cancer specialty care services * Improve patients' health related quality of life (HRQL) * Improve clinicians' ratings of quality of patient contacts * Reduce healthcare utilization and costs (obtained via the EMR) | Behavioural | Intervention |
Primary outcome
Amount of ICCS use and women's ratings of cancer information competence, perceived social support, and emotional well being. Secondary outcomes will include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare visits.
Time frame: 12 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 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 principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.) in people with Primary Breast Cancer, run by University of Wisconsin, Madison at 1 site 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 2 inclusion and 2 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 1 site 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?
Amount of ICCS use and women's ratings of cancer information competence, perceived social support, and emotional well being. Secondary outcomes will include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare visits. (time frame: 12 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 18 Nov 2019.