Breast CancerPhase 4NCT00156039
Randomized Trial of Follow-up Strategies in Breast Cancer
A Phase 4 study testing Follow-up Strategy for Breast Cancer in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 5 sites in Canada.
Trial summary
The purpose of this study is to determine whether family physician 'routine follow-up care' of women with breast cancer in remission is an acceptable alternative to the existing system of specialist follow-up. Primary outcome measure are event rates of oncological catastrophes and quality of life. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Follow-up Strategy for Breast Cancer
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 968 participants
- Where
- 5 sitesCanada
- Study dates
- Jan 1997to Jun 2003
- Phase
- Phase 4
- 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
- Women with breast cancer on well follow-up at regional cancer centres in Ontario and Manitoba
- Diagnosed at least 12 months previously (range 9-15 months)
- Without evidence of active disease (i.e., stages IIIB and IV excluded)
- Free from any primary treatment complications
Who cannot join
- Primary treatment at least 3 months previously, except for continued use of tamoxifen
- Still experiencing complications of primary treatment (patients will become eligible once complications resolve provided they are within the 6 month window)
- Unable to identify an acceptable family physician to provide follow-up
- Language or literacy skills inconsistent with completing questionnaires
- Unable to comply with study protocol including completion of questionnaires
- Previously enrolled in a study which requires continued follow-up in specialist or peripheral clinics
- Actively followed at a cancer centre for another primary cancer
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Kingston Regional Cancer Centre
Kingston, Ontario, K7M 4J2
Ottawa Hospital - Integrate Cancer Program
Ottawa, Ontario, K1H 8L6
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Toronto Sunnybrook Hospital
Toronto, Ontario, M4N 3M5
About this study
Official title: A Randomized Trial of Follow-up Strategies in Breast Cancer
The purpose of this study is to determine whether family physician 'routine follow-up care' of women with breast cancer in remission is an acceptable alternative to the existing system of specialist follow-up. Primary outcome measure are event rates of oncological catastrophes and quality of life.
Read the detailed description
see above
- Conditions
- Breast Cancer
- Being tested
- Follow-up Strategy for Breast Cancer
- Keywords
- Breast Cancer, Follow-up Strategy, Follow-up Care, Family Physician, Oncologist
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up Strategy for Breast CancerBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinically catastrophic events
Measured: Up to 5 yrs after randomization
Rate of Karnofsky performance status < 70
Measured: Up to 5 yrs after randomization
Psychosocial well being of patients in remission
Measured: Up to 5 yrs after randomization
Secondary outcomes (3)
Health Related Quality of Life after recurrence
Measured: Up to 5 yrs after randomization
Survival
Measured: Up to 5 yrs after randomization
Economic evaluation
Measured: Up to 5 yrs after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 1997
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 968 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Initiative
- Investigators
- Eva Grunfeld, MD, Study chair, Cancer Care Nova ScotiaMark Levine, MD, Principal investigator, Ontario Clinical Oncology Group (OCOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156039
- Sponsor's protocol ID
- OCOG-1997-FUP
- Other IDs
- CBCRI-grant-010413
- Status last verified
- Jul 2009
- First submitted
- 8 Sep 2005
- Last updated
- 28 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Grunfeld E, Levine MN, Julian JA, Coyle D, Szechtman B, Mirsky D, Verma S, Dent S, Sawka C, Pritchard KI, Ginsburg D, Wood M, Whelan T. Randomized trial of long-term follow-up for early-stage breast cancer: a comparison of family physician versus specialist care. J Clin Oncol. 2006 Feb 20;24(6):848-55. doi: 10.1200/JCO.2005.03.2235. Epub 2006 Jan 17.
PubMed 16418496
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Follow-up Strategies in Breast Cancer
- ClinicalTrials.gov ID
- NCT00156039
- Acronym / sponsor ID
- OCOG-1997-FUP
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Follow-up Strategy, Follow-up Care, Family Physician, Oncologist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 968 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Canadian Breast Cancer Initiative
- Study start
- Jan 1997
- Study completion
- Jun 2003 (actual)
- First posted
- 12 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.
The purpose of this study is to determine whether family physician 'routine follow-up care' of women with breast cancer in remission is an acceptable alternative to the existing system of specialist follow-up. Primary outcome measure are event rates of oncological catastrophes and quality of life.
Detailed description
see above
Study design
- Primary purpose
- Prevention
- 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 (4 listed)
- Women with breast cancer on well follow-up at regional cancer centres in Ontario and Manitoba
- Diagnosed at least 12 months previously (range 9-15 months)
- Without evidence of active disease (i.e., stages IIIB and IV excluded)
- Free from any primary treatment complications
Key exclusion criteria (7 listed)
- Primary treatment at least 3 months previously, except for continued use of tamoxifen
- Still experiencing complications of primary treatment (patients will become eligible once complications resolve provided they are within the 6 month window)
- Unable to identify an acceptable family physician to provide follow-up
- Language or literacy skills inconsistent with completing questionnaires
- Unable to comply with study protocol including completion of questionnaires
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 |
|---|---|---|
| Follow-up Strategy for Breast Cancer | Behavioural | – |
Primary outcome
Rate of clinically catastrophic events
Time frame: Up to 5 yrs after randomization
Rate of Karnofsky performance status < 70
Time frame: Up to 5 yrs after randomization
Psychosocial well being of patients in remission
Time frame: Up to 5 yrs after randomization
3 secondary outcomes
Health Related Quality of Life after recurrence
Time frame: Up to 5 yrs after randomization
Survival
Time frame: Up to 5 yrs after randomization
Economic evaluation
Time frame: Up to 5 yrs after randomization
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 28 Jul 2009.
- Results publication: PubMed 16418496Grunfeld E, Levine MN, Julian JA, Coyle D, Szechtman B, Mirsky D, Verma S, Dent S, Sawka C, Pritchard KI, Ginsburg D, Wood M, Whelan T. Randomized trial of long-term follow-up for early-stage breast cancer: a comparison of family physician versus specialist care. J Clin Oncol. 2006 Feb 20;24(6):848-55. doi: 10.1200/JCO.2005.03.2235. Epub 2006 Jan 17.
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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.
Eva Grunfeld, MD study chair
Cancer Care Nova Scotia
Mark Levine, MD principal investigator
Ontario Clinical Oncology Group (OCOG)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Follow-up Strategy for Breast Cancer in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 5 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 4 inclusion and 7 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 28 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Rate of clinically catastrophic events (time frame: Up to 5 yrs after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00156039, which also lists 1 linked publication.
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 28 Jul 2009.