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Moderating the Negative Impact of Abnormal Screening Mammograms

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Health Enhancement Support System (CHESS.)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring 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.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of WI Comprehensive Cancer Center and UW Health Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Intervention: Usual Care

Intervention

Arm Description

A group receiving usual care plus 5 reliable websites

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

Outcomes

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2010
Last Updated
February 27, 2014
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01153126
Brief Title
Moderating the Negative Impact of Abnormal Screening Mammograms
Official Title
Moderating the Negative Impact of Abnormal Screening Mammograms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Intervention: Usual Care
Arm Type
No Intervention
Arm Description
A group receiving usual care plus 5 reliable websites
Arm Title
Intervention
Arm Type
Experimental
Arm Description
A group using the Comprehensive Health Enhancement Support System (CHESS.)
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Health Enhancement Support System (CHESS.)
Intervention Description
Half of the participating women will be randomly assigned to usual care and half will be offered a fully CHESS.
Primary Outcome Measure Information:
Title
This design will allow us to compare the health information competence, psychological distress, and patient satisfaction with their doctor among the two groups.
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.
Time Frame
3 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of WI Comprehensive Cancer Center and UW Health Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53716
Country
United States

12. IPD Sharing Statement

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Moderating the Negative Impact of Abnormal Screening Mammograms

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