Breast CancerNCT01153126
Moderating the Negative Impact of Abnormal Screening Mammograms
A study testing Comprehensive Health Enhancement Support System (CHESS.) in people with Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This project evaluates the impact of CHESS-Mammo by assessing participants' health information competence, psychological distress, and satisfaction with their doctor as measured by previously validated survey questionnaires. 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?
- 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
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 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
- To be eligible for the study, subjects must:
- Be females at least 18 years of age,
- Have had their screening mammogram performed at the UW Breast Center,
- Be able to read and write English at the 6th grade level (as shown by their, ability to understand the informed consent),
- Have access to a computer with internet capability.
Who cannot join
- Illiterate
- Homeless
Trial locations and contacts
1 site in 1 country.
United States1 site
University of WI Comprehensive Cancer Center and UW Health Clinics
Madison, Wisconsin, 53716
About this study
This project evaluates the impact of CHESS-Mammo by assessing participants' health information competence, psychological distress, and satisfaction with their doctor as measured by previously validated survey questionnaires.
Read the detailed description
The study consists of two parts. Part 1 (focus groups) interviewed 11 women in total (6 diagnosed with breast cancer and 5 diagnosed with benign breast disease) reinforced the need for online information during the breast diagnostic process. The focus group reviewed online CHESS-Mammo module and suggested minor changes to content. Part 2 (Evaluation) will enroll 130 women in study and compare one group (65 participants) who receives access to CHESS-Mammo to another group of women (65 participants) who receive an email message containing screening mammography information. Both groups in Part 2 will be evaluated for health information competence, psychological distress, and patient satisfaction with physician through questionnaires. An evaluation of the group that accesses the CHESS-Mammo website will be done. The reason for conducting part 2 of this study is to allow greater insight into the clinical application of a novel Interactive Cancer Communication Systems (CHESS-Mammo) early in the diagnostic workup of breast cancer. By doing this project, we may achieve an important new way of implementing CHESS-Mammo in the clinic.
- Conditions
- Breast Cancer
- Being tested
- Comprehensive Health Enhancement Support System (CHESS.)
- Keywords
- Diagnostic Imaging, Breast Screening, Breast Cancer, To be eligible for the study, subjects must:, Be females at least 18 years of age,, Have had their screening mammogram performed at the UW Breast Center,, Be able to read and write English at the 6th grade level (as shown by their, ability to understand the informed consent),, Have access to a computer with internet capability.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Health Enhancement Support System (CHESS.)Behavioural
Half of the participating women will be randomly assigned to usual care and half will be offered a fully CHESS.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Usual Care | No intervention | A group receiving usual care plus 5 reliable websites |
| Intervention | Experimental | A group using the Comprehensive Health Enhancement Support System (CHESS.) Receives: Behavioral: Comprehensive Health Enhancement Support System (CHESS.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
This design will allow us to compare the health information competence, psychological distress, and patient satisfaction with their doctor among the two groups.
This is a randomized controlled trial in which half of the participants will receive access to CHESS-Mammo during their diagnostic workup of an abnormal screening mammogram, and the other half will receive basic information in addition to usual care. This design will allow us to compare the health information competence, psychological distress, and patient satisfaction with their doctor among the two groups.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2013
- Study completionDec 2013
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153126
- Sponsor's protocol ID
- XPO8110/2009-1092
- Other IDs
- 5P50CA095817
- Status last verified
- Feb 2014
- First submitted
- 28 Jun 2010
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderating the Negative Impact of Abnormal Screening Mammograms
- ClinicalTrials.gov ID
- NCT01153126
- Acronym / sponsor ID
- XPO8110/2009-1092
- Conditions
- Breast Cancer
- Keywords
- Diagnostic Imaging, Breast Screening, Breast Cancer, To be eligible for the study, subjects must:, Be females at least 18 years of age,, Have had their screening mammogram performed at the UW Breast Center,, Be able to read and write English at the 6th grade level (as shown by their, ability to understand the informed consent),, Have access to a computer with internet capability.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jun 2010 (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.
This project evaluates the impact of CHESS-Mammo by assessing participants' health information competence, psychological distress, and satisfaction with their doctor as measured by previously validated survey questionnaires.
Detailed description
The study consists of two parts. Part 1 (focus groups) interviewed 11 women in total (6 diagnosed with breast cancer and 5 diagnosed with benign breast disease) reinforced the need for online information during the breast diagnostic process. The focus group reviewed online CHESS-Mammo module and suggested minor changes to content. Part 2 (Evaluation) will enroll 130 women in study and compare one group (65 participants) who receives access to CHESS-Mammo to another group of women (65 participants) who receive an email message containing screening mammography information. Both groups in Part 2 will be evaluated for health information competence, psychological distress, and patient satisfaction with physician through questionnaires. An evaluation of the group that accesses the CHESS-Mammo website will be done. The reason for conducting part 2 of this study is to allow greater insight into the clinical application of a novel Interactive Cancer Communication Systems (CHESS-Mammo) early in the diagnostic workup of breast cancer. By doing this project, we may achieve an important new way of implementing CHESS-Mammo in the clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Usual Care | No intervention | –A group receiving usual care plus 5 reliable websites |
| Intervention | Experimental | Behavioral: Comprehensive Health Enhancement Support System (CHESS.)A group using 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 (5 listed)
- Be females at least 18 years of age,
- Have had their screening mammogram performed at the UW Breast Center,
- Be able to read and write English at the 6th grade level (as shown by their, ability to understand the informed consent),
- Have access to a computer with internet capability.
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 |
|---|---|---|
| Comprehensive Health Enhancement Support System (CHESS.)Half of the participating women will be randomly assigned to usual care and half will be offered a fully CHESS. | Behavioural | Intervention |
Primary outcome
This design will allow us to compare the health information competence, psychological distress, and patient satisfaction with their doctor among the two groups.
Time frame: 3 weeks
This is a randomized controlled trial in which half of the participants will receive access to CHESS-Mammo during their diagnostic workup of an abnormal screening mammogram, and the other half will receive basic information in addition to usual care. This design will allow us to compare the health information competence, psychological distress, and patient satisfaction with their doctor among the two groups.
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 3 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Health Enhancement Support System (CHESS.) in people with 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 5 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 3 Mar 2014. 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?
This design will allow us to compare the health information competence, psychological distress, and patient satisfaction with their doctor among the two groups. (time frame: 3 weeks). 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 3 Mar 2014.