Moderating the Negative Impact of Abnormal Screening Mammograms

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01153126
First received: June 28, 2010
Last updated: February 27, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01153126     History of Changes
Other Study ID Numbers: XPO8110/2009-1092, 5P50CA095817
Study First Received: June 28, 2010
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

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.

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014