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Moderating the Negative Impact of Abnormal Screening Mammograms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01153126
First Posted: June 29, 2010
Last Update Posted: March 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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.

Condition Intervention
Breast Cancer Behavioral: Comprehensive Health Enhancement Support System (CHESS.)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Moderating the Negative Impact of Abnormal Screening Mammograms

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • This design will allow us to compare the health information competence, psychological distress, and patient satisfaction with their doctor among the two groups. [ Time Frame: 3 weeks ]
    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.


Enrollment: 130
Study Start Date: May 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Intervention: Usual Care
A group receiving usual care plus 5 reliable websites
Experimental: Intervention
A group using the Comprehensive Health Enhancement Support System (CHESS.)
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153126


Locations
United States, Wisconsin
University of WI Comprehensive Cancer Center and UW Health Clinics
Madison, Wisconsin, United States, 53716
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01153126     History of Changes
Other Study ID Numbers: XPO8110/2009-1092
5P50CA095817 ( U.S. NIH Grant/Contract )
First Submitted: June 28, 2010
First Posted: June 29, 2010
Last Update Posted: March 3, 2014
Last Verified: February 2014

Keywords provided by University of Wisconsin, Madison:
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.