Educational Interventions for Patients With DCIS - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00148655

Purpose

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	Intervention
DCIS	Device: Decision Board

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Randomized Trial for Educational Interventions for Patients With DCIS Actually Making Treatment Decisions

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the impact of an educational intervention on the decision-making in women with DCIS. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	May 2003
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Decision board that explains the risks and benefits of treatment options

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.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148655

Locations

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

Investigators

Principal Investigator:

Eric Winer, MD

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Eric Winer, MD )
Study ID Numbers:	02-331
Study First Received:	September 7, 2005
Last Updated:	December 22, 2007
ClinicalTrials.gov Identifier:	NCT00148655
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

educational intervention
decision board
DCIS

Study placed in the following topic categories:

Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on January 16, 2009