Moderating the Negative Impact of Abnormal Screening Mammograms
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Behavioral: Comprehensive Health Enhancement Support System (CHESS.) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Moderating the Negative Impact of Abnormal Screening Mammograms |
- 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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 130 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: No Intervention: Usual Care
A group receiving usual care plus 5 reliable websites
|
|
|
Experimental: Intervention
A group using the Comprehensive Health Enhancement Support System (CHESS.)
|
Behavioral: 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
Exclusion Criteria:
- Illiterate
- Homeless
Contacts and Locations| United States, Wisconsin | |
| University of WI Comprehensive Cancer Center and UW Health Clinics | Recruiting |
| Madison, Wisconsin, United States, 53716 | |
| Contact: Helene McDowell, M.S. 608.262.1753 helene.mcdowell@chess.wisc.edu | |
| Principal Investigator: Elizabeth Burnside, M.D., MPH., MS. | |
More Information
No publications provided
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT01153126 History of Changes |
| Other Study ID Numbers: | XPO8110/2009-1092, 5P50CA095817 |
| Study First Received: | June 28, 2010 |
| Last Updated: | November 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Wisconsin, Madison:
|
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. |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013