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OpenTrials
Completed

NCT Number: NCT00473096

Efficacy Study of an Educational Program for Decision Support for Breast Cancer

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Informed breast cancer surgical treatment

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • U.S. Army Medical Research and Development Command

Registry information

Official study title

Assessing the Efficacy of a CDSS for Breast Cancer

Acronym: H-6019

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
May 14, 2007
Registry last updated
Feb 28, 2020

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.

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