Breast CancerPhase 3NCT00201929
A Decision Aid for Women With Early Stage Breast Cancer
A Phase 3 study testing Standard Decision Board, Computer Decision Board and Paper Decision Board in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 9 sites in Canada.
Trial summary
To enhance information transfer and decision making for women with breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Standard Decision Board, Computer Decision Board and Paper Decision Board
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 9 sitesCanada
- Study dates
- Apr 2002to Nov 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Denise Schnider
Brantford, Ontario, N3R 1G8
Ken Reed
Guelph, Ontario, N1E 6L9
Susan Reid
Hamilton, Ontario, L8N 3Z5
Barbara Heller
Hamilton, Ontario, L8P 3A9
Ken Sanders
Hamilton, Ontario, L8V 4T9
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Nabih Mattar
Simcoe, Ontario, N3Y 1T4
Anna Kobylecky
St. Catharines, Ontario, L2S 3P1
Peter Koziarz
Welland, Ontario, L3B 5X9
About this study
Official title: Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer
To enhance information transfer and decision making for women with breast cancer.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Standard Decision Board, Computer Decision Board, Paper Decision Board
- Keywords
- breast cancer, decision aid, Decision Board, information transfer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Decision BoardProcedure or surgery
Computer Decision BoardProcedure or surgery
Paper Decision BoardProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comprehension
Patient satisfaction with information transfer
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2002
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, Supportive Cancer Care Research Unit
- Investigators
- Timothy Whelan, MD, Study chair, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201929
- Sponsor's protocol ID
- SCCR-Unit-Decision Board
- Other IDs
- DAMD17-98-1-8100
- Status last verified
- Jun 2007
- First submitted
- 13 Sep 2005
- Last updated
- 29 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Different Versions of the Decision Board for Early Breast Cancer
- ClinicalTrials.gov ID
- NCT00201929
- Acronym / sponsor ID
- SCCR-Unit-Decision Board
- Conditions
- Breast Cancer
- Keywords
- breast cancer, decision aid, Decision Board, information transfer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, Supportive Cancer Care Research Unit
- Study start
- Apr 2002
- Study completion
- Nov 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Female
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Decision Board | Procedure or surgery | – |
| Computer Decision Board | Procedure or surgery | – |
| Paper Decision Board | Procedure or surgery | – |
Primary outcome
Patient comprehension
Patient satisfaction with information transfer
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2007.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Whelan, MD study chair
Juravinski Cancer Centre
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard Decision Board, Computer Decision Board and Paper Decision Board in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient comprehension. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2007.