Skip to main content
OpenTrials
Completed

NCT Number: NCT01153126

Moderating the Negative Impact of Abnormal Screening Mammograms

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of WI Comprehensive Cancer Center and UW Health Clinics

Madison, Wisconsin, 53716, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Health Enhancement Support System (CHESS.)

Behavioral

Half of the participating women will be randomly assigned to usual care and half will be offered a fully CHESS.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 29, 2010
Registry last updated
Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.