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


N/A
25 Years
N/A
Not Enrolling
Female
DCIS

Thank you

Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Eric Winer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

02-331

NCT ID:

NCT00148655

Start Date:

May 2003

Completion Date:

August 2006

Related Keywords:

  • DCIS
  • educational intervention
  • decision board
  • DCIS
  • Carcinoma, Intraductal, Noninfiltrating

Name

Location

Faulkner HospitalJamaica Plain, Massachusetts  02130
Dana-Farber Cancer CenterBoston, Massachusetts  02115