Moderating the Negative Impact of Abnormal Screening Mammograms

Study Overview
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Brief Summary
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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
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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.

Official Title
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Moderating the Negative Impact of Abnormal Screening Mammograms

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Comprehensive Health Enhancement Support System (CHESS.)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Intervention: Usual Care<br>A group receiving usual care plus 5 reliable websites | |
| Experimental: Intervention<br>A group using the Comprehensive Health Enhancement Support System (CHESS.) | Behavioral: Comprehensive Health Enhancement Support System (CHESS.)<br>* Half of the participating women will be randomly assigned to usual care and half will be offered a fully CHESS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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.