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Educational Interventions for Patients With DCIS

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00148655
First received: September 7, 2005
Last updated: December 22, 2007
Last verified: December 2007
History of Changes
  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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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:
    Device: Decision Board
    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

No publications provided

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

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

Additional relevant MeSH terms:
Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on May 19, 2013