Moderating the Negative Impact of Abnormal Screening Mammograms

NCT ID: NCT01153126

Last Updated: 2014-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

No Intervention: Usual Care

A group receiving usual care plus 5 reliable websites

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type: EXPERIMENTAL

Comprehensive Health Enhancement Support System (CHESS.)

Intervention Type: BEHAVIORAL

Half of the participating women will be randomly assigned to usual care and half will be offered a fully CHESS.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Illiterate
• Homeless

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of WI Comprehensive Cancer Center and UW Health Clinics

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

5P50CA095817

Identifier Type: NIH

Identifier Source: secondary_id

View Link

XPO8110/2009-1092

Identifier Type: -

Identifier Source: org_study_id