Clinical trial NCT00201929: A Decision Aid for Women With Early Stage Breast Cancer
Official title: Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: breast cancer
decision aid
Decision Board
information transfer
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
name: Supportive Cancer Care Research Unit
First posted: 2005-09-20
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To enhance information transfer and decision making for women with breast cancer.

Detailed description: Our specific objectives are: (i) to develop computer and paper based versions of the Decision Boards for (a) chemotherapy for early stage breast cancer (chemotherapy versus no treatment), (b) mastectomy versus lumpectomy plus radiation and (ii) to compare the relative effectiveness of the computer and paper based versions with the standard Decision Board for patients with early breast cancer.

Eligibility criteria: Inclusion Criteria:

Chemotherapy Group:

* Female
* Histologically documented invasive carcinoma of the breast treated with modified radical mastectomy or lumpectomy
* Axillary node dissection
* Chemotherapy alone or in addition to tamoxifen as an appropriate treatment option

Surgery Group:

* Female
* Newly diagnosed carcinoma of the breast diagnosed either by cytology or pathological examination, OR if no biopsy, a strong clinical suspicion of malignancy
* Clinical stage I or II disease
* Candidate for breast conserving surgery

Exclusion Criteria:

Chemotherapy Group:

* Candidate for CEF chemotherapy
* Clinical evidence of metastatic disease
* Serious comorbidity that would preclude receiving chemotherapy treatment
* Unable to speak or read English fluently (including visual impairment)
* Mentally incompetent including any psychiatric or addictive disorders that would preclude shared decision-making

Surgery Group:

* Previous surgery for breast cancer
* Previous breast irradiation
* Pregnant
* Clinical suspicion of bilateral breast cancer
* Serious comorbidity that would preclude definitive surgery
* Unable to speak or read English fluently (including visual impairment)
* Mentally incompetent including any psychiatric or addictive disorder that would preclude shared decision making

Primary outcomes:
measure: Patient comprehension
measure: Patient satisfaction with information transfer
Secondary outcomes:
measure: Patient satisfaction with decision making
measure: Physician satisfaction with information transfer
measure: Physician satisfaction with decision making
measure: Time required for administration of the instrument
measure: Patient preference for decision making
Other outcomes:
Locations:
city: Brantford
country: Canada
facility: Denise Schnider
state: Ontario
city: Guelph
country: Canada
facility: Ken Reed
state: Ontario
city: Hamilton
country: Canada
facility: Susan Reid
state: Ontario
city: Hamilton
country: Canada
facility: Barbara Heller
state: Ontario
city: Hamilton
country: Canada
facility: Ken Sanders
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Simcoe
country: Canada
facility: Nabih Mattar
state: Ontario
city: St. Catharines
country: Canada
facility: Anna Kobylecky
state: Ontario
city: Welland
country: Canada
facility: Peter Koziarz
state: Ontario
Study officials:
affiliation: Juravinski Cancer Centre
name: Timothy Whelan, MD
role: STUDY_CHAIR
References: