A Decision Aid for Women With Early Stage Breast Cancer
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00201929 |
|
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: June 29, 2007
|
Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborators:
U.S. Army Medical Research and Materiel Command
Supportive Cancer Care Research Unit
Information provided by:
Ontario Clinical Oncology Group (OCOG)
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
To enhance information transfer and decision making for women with breast cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Procedure: Standard Decision Board Procedure: Computer Decision Board Procedure: Paper Decision Board | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Official Title: | Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer |
| Study Start Date : | April 2002 |
| Actual Study Completion Date : | November 2006 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
U.S. FDA Resources
Primary Outcome Measures
:
- Patient comprehension
- Patient satisfaction with information transfer
Secondary Outcome Measures
:
- 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
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00201929
Locations
| Canada, Ontario | |
| Denise Schnider | |
| Brantford, Ontario, Canada, N3R 1G8 | |
| Ken Reed | |
| Guelph, Ontario, Canada, N1E 6L9 | |
| Susan Reid | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Barbara Heller | |
| Hamilton, Ontario, Canada, L8P 3A9 | |
| Ken Sanders | |
| Hamilton, Ontario, Canada, L8V 4T9 | |
| Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Nabih Mattar | |
| Simcoe, Ontario, Canada, N3Y 1T4 | |
| Anna Kobylecky | |
| St. Catharines, Ontario, Canada, L2S 3P1 | |
| Peter Koziarz | |
| Welland, Ontario, Canada, L3B 5X9 | |
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
U.S. Army Medical Research and Materiel Command
Supportive Cancer Care Research Unit
Investigators
| Study Chair: | Timothy Whelan, MD | Juravinski Cancer Centre |
| ClinicalTrials.gov Identifier: | NCT00201929 History of Changes |
| Other Study ID Numbers: |
SCCR-Unit-Decision Board DAMD17-98-1-8100 |
| First Posted: | September 20, 2005 Key Record Dates |
| Last Update Posted: | June 29, 2007 |
| Last Verified: | June 2007 |
Keywords provided by Ontario Clinical Oncology Group (OCOG):
|
breast cancer decision aid Decision Board information transfer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |