Moderating the Negative Impact of Abnormal Screening Mammograms

Breast Cancer Clinical Trial

Official title:

Moderating the Negative Impact of Abnormal Screening Mammograms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153126
• Other study ID #: XPO8110/2009-1092
• Secondary ID: 5P50CA095817
• Status: Completed
• Phase: N/A
• First received: June 28, 2010
• Last updated: February 27, 2014
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	University of WI Comprehensive Cancer Center and UW Health Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No