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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

September 7, 2005
December 22, 2007
May 2003
August 2006   (final data collection date for primary outcome measure)
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 ]
To determine the impact of an educational intervention on the decision-making in women with DCIS.
Complete list of historical versions of study NCT00148655 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
Educational Interventions for Patients With DCIS
A Randomized Trial for Educational Interventions for Patients With DCIS Actually Making Treatment Decisions

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.

  • 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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
DCIS
Device: Decision Board
Decision board that explains the risks and benefits of treatment options
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2006
August 2006   (final data collection date for primary outcome measure)

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
Female
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00148655
02-331
Not Provided
Eric Winer, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Eric Winer, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP