A Decision Aid for Women With Early Stage Breast Cancer

Study Overview
=================
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.

Official Title
-----------------
Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Standard Decision Board
* Procedure: Computer Decision Board
* Procedure: Paper Decision Board


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Standard Decision Board|nan|
|Procedure: Computer Decision Board|nan|
|Procedure: Paper Decision Board|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comprehension |  |  | 
| Patient satisfaction with information transfer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with decision making |  |  | 
| Physician satisfaction with information transfer |  |  | 
| Physician satisfaction with decision making |  |  | 
| Time required for administration of the instrument |  |  | 
| Patient preference for decision making |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, decision aid, Decision Board, information transfer