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Moderating the Negative Impact of Abnormal Screening Mammograms


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Moderating the Negative Impact of Abnormal Screening Mammograms


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

This design will allow us to compare the health information competence, psychological distress, and patient satisfaction with their doctor among the two groups.

Outcome Description:

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.

Outcome Time Frame:

3 weeks

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

XPO8110/2009-1092

NCT ID:

NCT01153126

Start Date:

May 2010

Completion Date:

December 2011

Related Keywords:

  • Breast Cancer
  • 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.
  • Breast Neoplasms

Name

Location

University of WI Comprehensive Cancer Center and UW Health ClinicsMadison, Wisconsin  53716