H-6019: Efficacy Study of an Educational Program for Decision Support for Breast Cancer

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00473096
• Collaborator: U.S. Army Medical Research and Development Command (U.S. Fed)
• Enrollment: 100
• Location: 1
• Duration (Months): 72
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The purpose of this study is to develop and test an informative computer-based program to help women in making good choices among options for treating early stage breast cancer. Women who are exposed to the computerized program will, when compared to women who receive standard of care offered at the hospital: (a) be more knowledgeable about treatment options,(b) be more satisfied with their treatment decision, and (c) be more assured about their treatment choice.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Behavioral: Informed breast cancer surgical treatment	N/A

Detailed Description

The purpose of this project is to develop and test a computer-based decision support system on breast cancer for low-income women who speak English or Spanish. This project is designed to respond to the under utilization of breast conserving surgery by women with early stage breast cancer, as indicated by both national and local data on treatment choices. The literature suggests that underuse of BCS by women for whom it is the recommended therapy may relate to inadequacies in efforts to educate them about treatment options. The program was designed to convey information to women with varying levels of reading ability. This was done through multimedia approaches which include voice-over narrative in simple English or Spanish, and use of photo novella and/or "soap opera" presentation of situational material that allows women to explore possible consequences associated with different decisions.

Comparison(s): Women exposed to the computer-based decision support program on breast cancer treatment, receiving standard care and education offered at two public hospitals, compared to women exposed to standard care and education at the same public hospitals.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Assessing the Efficacy of a CDSS for Breast Cancer
• Study Start Date: Oct 1, 2000
• Actual Primary Completion Date: Oct 1, 2006
• Actual Study Completion Date: Oct 1, 2006

Outcome Measures

Primary Outcome Measures

1. Treatment decisions more consistent with preferences (utilities)at pre-operation []

2. Breast cancer treatment knowledge at 6 month and 1 year []

3. Certainty about treatment choice at pre-operation []

Secondary Outcome Measures

1. Satisfaction with decision at the pre-operation, 6 month and 1 year []

2. Preferences for decision making at pre-operation []

3. Satisfaction with the decision making process at pre-operation, 6 month and 1 year []

4. Functional status at 6 month and 1 year []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female

• Breast cancer diagnosis in stages I, IIA, IIB, or IIIA

• Candidates for surgery

• Speak English or Spanish

Exclusion Criteria:

• Breast cancer diagnosis in stages 0, IIIB, or IV

• Recurrent breast cancer or inflammatory breast carcinoma

• Not eligible for lumpectomy with radiation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor College of Medicine	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine
• U.S. Army Medical Research and Development Command

Investigators

• Principal Investigator: Maria L Jibaja Weiss, EdD, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria Jibaja Weiss, Associate Professor, Duncan Cancer Center, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT00473096
• Other Study ID Numbers: DAMD17-98-1-8022
• First Posted: May 14, 2007
• Last Update Posted: Feb 28, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Maria Jibaja Weiss, Associate Professor, Duncan Cancer Center, Baylor College of Medicine: Decision making; Patient Education; Indigency; Minority group
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Feb 28, 2020