Moderating the Negative Impact of Abnormal Screening Mammograms

University of Wisconsin (UW)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Comprehensive Health Enhancement Support System (CHESS.)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01153126

XPO8110/2009-1092

5P50CA095817 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

No Intervention: Usual Care

No Intervention group

Description:

A group receiving usual care plus 5 reliable websites

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Comprehensive Health Enhancement Support System (CHESS.)