Moderating the Negative Impact of Abnormal Screening Mammograms

NCT01153126 | Completed DMC

• 2 other identifiers: XPO8110/2009-10925P50CA095817
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

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.

Outcome Measures

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.

  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.

  3 weeks

Study Arms (2)

No Intervention: Usual Care

NO INTERVENTION

A group receiving usual care plus 5 reliable websites

Intervention

EXPERIMENTAL

A group using the Comprehensive Health Enhancement Support System (CHESS.)

Behavioral: Comprehensive Health Enhancement Support System (CHESS.)

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Illiterate
• Homeless

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of WI Comprehensive Cancer Center and UW Health Clinics

Madison, Wisconsin, 53716, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 29, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 3, 2014

Record last verified: 2014-02

Locations

US (1)