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OpenTrials
Completed

NCT Number: NCT00148655

Educational Interventions for Patients With DCIS

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.

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Key information

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Center, Boston, Massachusetts, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Decision Board

Device

Decision board that explains the risks and benefits of treatment options

Primary outcomes

  1. To determine the impact of an educational intervention on the decision-making in women with DCIS.

    Time frame: 3 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Official study title

A Randomized Trial for Educational Interventions for Patients With DCIS Actually Making Treatment Decisions

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 8, 2005
Registry last updated
Dec 28, 2007

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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