Breast CancerNCT02660788
A Randomized Trial of Letters From Family Physicians to Encourage Screening Mammography in Overdue Women
A study testing Standard Reminder Postcard and Family Physician Reminder Letter in people with Breast Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
A randomized, double-blinded study conducted in British Columbia, Canada, where there is a publicly funded, organized screening program and screening mammography is recommended at 24-month intervals. Read more about this study
- Who is it for?
- Ages 51 to 73 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Standard Reminder Postcard and Family Physician Reminder Letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,498 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 51 to 73 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active family physicians (family physicians, general practitioners or primary care physicians) who have overdue women in their practice that meet the following criteria:
- Previously been enrolled in the SMPBC and had a previous normal screening mammogram.
- Have agreed to being contacted for research on the SMPBC questionnaire
- Are 6-24 months overdue from their last screening mammogram
- Live in BC
- Have listed an active family physician as the contact to receive their mammography results
Who cannot join
- Family physicians who do not work in primary care
- Family physicians who do not have overdue women in their practice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Study of Screening Mammography Return Rates in Overdue Women Due to Standard Screening Mammography Program of British Columbia (Smpbc) Reminders Versus Reminder Letters Signed by Women's Family Physicians
A randomized, double-blinded study conducted in British Columbia, Canada, where there is a publicly funded, organized screening program and screening mammography is recommended at 24-month intervals. Eligible women aged 51-73 years old and overdue for their screening mammogram by 6-24 months are identified in the database of the Screening Mammography Program of BC (SMPBC). Family physicians are recruited by mail and asked to sign letters to the overdue women in their practices. The overdue women are randomized and mailed either the signed reminder letter and the standard reminder postcard, or the standard reminder postcard alone. The primary endpoint is the proportion of overdue women attending a screening mammogram appointment 6 months after the mailing.
- Conditions
- Breast Cancer
- Being tested
- Standard Reminder Postcard, Family Physician Reminder Letter
- Keywords
- 6-24 months overdue, screening mammography
- 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 Reminder PostcardOther
Family Physician Reminder LetterOther
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Mail Receives: Other: Standard Reminder Postcard |
| Family Physician Reminder Letter Arm | Experimental | Mail Receives: Other: Standard Reminder Postcard; Other: Family Physician Reminder Letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Overdue Women Returning for Screening Mammography
Percentage of overdue women returning for screening mammography, measured from the date of randomization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 5,498 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Responsible party
- Principal investigator, Alan Nichol, British Columbia Cancer Agency
- Investigators
- Alan Nichol, MD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660788
- Sponsor's protocol ID
- H12-02832
- Status last verified
- Sep 2021
- First submitted
- 18 Jan 2016
- Last updated
- 30 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chan EK, Wilson C, Tyldesley S, Olivotto IA, Lai A, Sam J, Harry R, Nichol A. Signed family physician reminder letters to women overdue for screening mammography: A randomized clinical trial. J Med Screen. 2018 Sep;25(3):149-154. doi: 10.1177/0969141317719921. Epub 2017 Nov 20.
PubMed 29157121
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study of Screening Mammography Return Rates in Overdue Women Due to Standard Screening Mammography Program of British Columbia (Smpbc) Reminders Versus Reminder Letters Signed by Women's Family Physicians
- ClinicalTrials.gov ID
- NCT02660788
- Acronym / sponsor ID
- H12-02832
- Conditions
- Breast Cancer
- Keywords
- 6-24 months overdue, screening mammography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,498 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Posted 2 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blinded study conducted in British Columbia, Canada, where there is a publicly funded, organized screening program and screening mammography is recommended at 24-month intervals. Eligible women aged 51-73 years old and overdue for their screening mammogram by 6-24 months are identified in the database of the Screening Mammography Program of BC (SMPBC). Family physicians are recruited by mail and asked to sign letters to the overdue women in their practices. The overdue women are randomized and mailed either the signed reminder letter and the standard reminder postcard, or the standard reminder postcard alone. The primary endpoint is the proportion of overdue women attending a screening mammogram appointment 6 months after the mailing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: Standard Reminder PostcardMail |
| Family Physician Reminder Letter Arm | Experimental | Other: Standard Reminder Postcard, Other: Family Physician Reminder LetterMail |
Who may qualify
- Ages
- 51 to 73 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Active family physicians (family physicians, general practitioners or primary care physicians) who have overdue women in their practice that meet the following criteria:
- Previously been enrolled in the SMPBC and had a previous normal screening mammogram.
- Have agreed to being contacted for research on the SMPBC questionnaire
- Are 6-24 months overdue from their last screening mammogram
- Live in BC
Key exclusion criteria (2 listed)
- Family physicians who do not work in primary care
- Family physicians who do not have overdue women in their practice
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 Reminder Postcard | Other | Control Arm, Family Physician Reminder Letter Arm |
| Family Physician Reminder Letter | Other | Family Physician Reminder Letter Arm |
Primary outcome
Percentage of Overdue Women Returning for Screening Mammography
Time frame: 6 months
Percentage of overdue women returning for screening mammography, measured from the date of randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29157121Chan EK, Wilson C, Tyldesley S, Olivotto IA, Lai A, Sam J, Harry R, Nichol A. Signed family physician reminder letters to women overdue for screening mammography: A randomized clinical trial. J Med Screen. 2018 Sep;25(3):149-154. doi: 10.1177/0969141317719921. Epub 2017 Nov 20.
- Individual participant dataSharing planned: No
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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.
Alan Nichol, MD principal investigator
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Reminder Postcard and Family Physician Reminder Letter in people with Breast Cancer, run by British Columbia Cancer Agency at 1 site 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 6 inclusion and 2 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 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Overdue Women Returning for Screening Mammography (time frame: 6 months). 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 NCT02660788, 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 30 Sep 2021.