A Decision Aid for Women With Early Stage Breast Cancer | NCT00201929

Studies
A Decision Aid for Women With Early Stage Breast Cancer

NCT00201929

Sponsor

Ontario Clinical Oncology Group (OCOG)

Status

Completed

Last Update Posted

Jun 29, 2007Estimated

Enrollment

300

Phase

Phase 3

Conditions

Breast Cancer

Interventions

Standard Decision Board
Computer Decision Board
Paper Decision Board

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DAMD17-98-1-8100

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2002

Primary Completion Date

Not provided

Completion Date

Nov 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2007

Last Update Posted Date

Jun 29, 2007Estimated

Name	Class
U.S. Army Medical Research and Development Command	FED
Supportive Cancer Care Research Unit	UNKNOWN

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Measure	Description	Time Frame
Patient comprehension
Patient satisfaction with information transfer

Measure	Description	Time Frame
Patient satisfaction with decision making
Physician satisfaction with information transfer
Physician satisfaction with decision making

Facility	Status	City	State	ZIP	Country	Contacts
Denise Schnider		Brantford	Ontario	N3R 1G8	Canada
Ken Reed

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Name	Type	Description	Arm Group Labels	Other Names
Standard Decision Board	Procedure
Computer Decision Board	Procedure
Paper Decision Board	Procedure