Clinical trial NCT01153126: Moderating the Negative Impact of Abnormal Screening Mammograms
Official title: Moderating the Negative Impact of Abnormal Screening Mammograms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: 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.
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-29
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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:

Exclusion Criteria:

* Illiterate
* Homeless

Primary outcomes:
measure: This design will allow us to compare the health information competence, psychological distress, and patient satisfaction with their doctor among the two groups.
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of WI Comprehensive Cancer Center and UW Health Clinics
state: Wisconsin
Study officials:
References: