Clinical trial NCT00148655: Educational Interventions for Patients With DCIS
Official title: A Randomized Trial for Educational Interventions for Patients With DCIS Actually Making Treatment Decisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DCIS
Keywords: educational intervention
decision board
DCIS
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2005-09-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 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.

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 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

Primary outcomes:
measure: To determine the impact of an educational intervention on the decision-making in women with DCIS.
timeFrame: 3 years
Secondary outcomes:
measure: 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.
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Faulkner Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Eric Winer, MD
role: PRINCIPAL_INVESTIGATOR
References: