Moderating the Negative Impact of Abnormal Screening Mammograms

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Comprehensive Health Enhancement Support System (CHESS.)

• Registration Number: NCT01153126
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Comprehensive Health Enhancement Support System (CHESS.)	A group using the Comprehensive Health Enhancement Support System (CHESS.)

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

University of WI Comprehensive Cancer Center and UW Health Clinics; 🇺🇸 Madison, Wisconsin, United States