Educational Interventions for Patients With DCIS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148655
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : December 28, 2007
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute

Brief Summary:
The purpose of this study is to determine whether adding an educational intervention, in the form of a decision board, which outlines the risks and benefits of treatment options for DCIS, at the time of the first surgical consultation will improve decision making for women with DCIS.

Condition or disease Intervention/treatment Phase
DCIS Device: Decision Board Not Applicable

Detailed Description:
  • The decision board explains the risks and benefits of mastectomy, excision and radiation, excision, radiation, and tamoxifen, excision alone, and excision without radiation and tamoxifen for women with DCIS.
  • Patients will receive a decision board to take home for review. Two fifteen-minute telephone interviews will be conducted, one approximately one week after enrollment and one 2 months after enrollment.
  • In the phone interviews, patients will asked to complete a brief survey. This survey will ask abou DCIS in general, the patient's treatment decisions, their feelings, as well as their experience with the decision board.
  • This study will take about 2 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Randomized Trial for Educational Interventions for Patients With DCIS Actually Making Treatment Decisions
Study Start Date : May 2003
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Intervention Details:
  • Device: Decision Board
    Decision board that explains the risks and benefits of treatment options

Primary Outcome Measures :
  1. To determine the impact of an educational intervention on the decision-making in women with DCIS. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To assess the effect of an intervention on 1)satisfaction with decision-making, 2)knowledge of treatment options, 3)risk assessment, 4)treatment choice, 5)factors motivating treatment choice and 6)anxiety related to diagnosis. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eligible patients will include women over the age of 25 with newly-diagnosed DCIS who are candidates for breast conserving therapy.
  • Pathologic confirmation of DCIS without evidence of invasive breast cancer and mammograms showing a single suspicious focus without mammographic or clinical evidence of multicentricity.
  • Patients that have not made a decision regarding management of DCIS
  • Eligible for radiotherapy to breast
  • Oral and written knowledge of English

Exclusion Criteria:

  • Patients that have undergone mastectomy
  • History of prior radiotherapy to the breast, scleroderma or systemic lupus erythematosus
  • Clinically palpable disease in the axilla or contralateral breast cancer
  • Co-morbidities that would render them ineligible for general anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00148655

United States, Massachusetts
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115
Faulkner Hospital
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Eric Winer, MD Dana-Farber Cancer Institute

Responsible Party: Eric Winer, MD, Dana-Farber Cancer Institute Identifier: NCT00148655     History of Changes
Other Study ID Numbers: 02-331
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007

Keywords provided by Dana-Farber Cancer Institute:
educational intervention
decision board