Breast CancerNCT01332032
Promoting Breast Cancer Screening in Non-adherent Women
An observational study of Breast Cancer, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
This randomized study compares the effectiveness and cost-effectiveness of 3 proven methods of reaching out to women who are coming due for or who are overdue for a mammogram. The study originally embedded in a community healthcare plan and an associated community clinic, now accepts patients using the community… Read more about this study
- Who is it for?
- Ages 40 to 84 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Reminder Letter, Reminder Call and Counselor Call
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36,348 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to May 2015
- Phase
- Observational
- 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 40 to 84 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged 40 to 84 who have life expectancy of five years, have at least one breast, and who have been cared for by Fallon Community Health Plan and currently cared for by Reliant Medical Group (formerly called Fallon Clinic) PCP. Interventions directed at women who are at least 18 months from prior mammogram. Since July 2012, patients with a current Reliant Medical Group PCP who have been enrolled in Blue Cross/Bluse Shield, Harvard Pilgrim or Tufts health plans for 18 months may be eligible for enrollment.
Who may be able to join
- women aged 40 through 84 years old
- in the Fallon Community Health Plan, Blue Cross, Tufts or Harvard Pilgrim health plans for 18 or more months
- has a current Reliant Medical Group (formerly called Fallon Clinic) primary care provider
- has working telephone
Who cannot join
- significant cognitive impairment
- serious illness, precluding screening
- bilateral mastectomy
- life expectancy less than 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Reliant Medical Group
Worcester, Massachusetts, 01605
About this study
This randomized study compares the effectiveness and cost-effectiveness of 3 proven methods of reaching out to women who are coming due for or who are overdue for a mammogram. The study originally embedded in a community healthcare plan and an associated community clinic, now accepts patients using the community clinic and 3 other health care plans. The study makes use of a complex computer driven reminder system.
The study also will examine ways to improve the efficiency and sequencing of the interventions by identifying patient factors associated with intervention effectiveness.
Read the detailed description
The randomized study compares three interventions. All eligible women are randomly assigned to 1 of 3 interventions. If they become 18 or more months from a prior mammogram, they will receive the intervention to which they were assigned.
The 3 arms are
- RL ARM: (reminder letter) a control arm which consists of a reminder letter only that states when the last mammogram was, contains a standard recommendation from her primary care provider (PCP), and requests that the woman call a special number for help scheduling a mammogram.
- RC ARM: (reminder call) a reminder letter as above, followed, if no response, by a reminder call from a study scheduler who offers to help schedule a mammogram.
- ETTC ARM: (enhanced tailored telephone counseling call) a reminder letter as above, followed, if no response by a second letter, a mammography educational booklet and a second request to call a special number to schedule a mammogram. If no response, a study counselor/educator will call.
A complex computer-based tracking system identifies women coming due for a mammogram or those overdue for a mammogram. The system interfaces with the clinic database systems and stores information re age, telephone number, address, prior screening dates, primary care provider name, scheduling dates, etc. The system can generate reminder letters as appropriate.
The tracking system also interfaces with computer-assisted telephone script systems(CATI) which prompt the study scheduler or the study counselor to follow the protocol that is tailored to the individual patient.
The CATI system captures data from all calls, including how ready a woman is to schedule, the answers to a brief socio-demographic survey and in the counselor call script barriers and misinformation about mammography.
The computer system also interfaces with the radiology scheduling system so that study personnel can assist women in scheduling a mammogram during the phone call.
The primary outcome is the number of women in each arm getting a mammogram. This data will come from the clinic data base and the healthcare plan billing system.
Secondary outcomes include evaluation of the effect of booster or repeat interventions in women failing to respond to prior request for mammogram.
- Conditions
- Breast Cancer
- Being tested
- Reminder Letter, Reminder Call, Counselor Call
- Keywords
- cost effectiveness, screening mammography, repeat mammography, telephone counseling, computerized reminders, compliance
- Medical subject headings
- Breast Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminder LetterBehavioural
Also called mammography reminder letter.
A letter sent to women reminding them that they are coming due or overdue for a mammogram. It contains a reminder that their doctor recommends mammography screening every 1-2 years; urges them to call a special number to a study scheduler to get assistance scheduling a mammogram and is signed electronically by their primary care provider. For women in the reminder letter only arm, who did not complete a mammogram within 12 months of the first reminder, a booster intervention (I.E. reminder letter) will be sent. The letter requests that a woman call in to schedule a mammogram, and reminds her that her PCP recommends she get one. Booster letters will be sent up to three times at annual intervals for those failing to get a mammogram
Reminder CallBehavioural
Also called mammography phone call
A reminder letter (as in the 1st group) is sent. If a woman does not call in to schedule a letter, 2 weeks later, a study scheduler will call her, remind her she is coming or is overdue, remind her that her PCP recommends screening every 1-2 years and offers to schedule a mammogram for her. For women in the reminder letter arm who did not complete a mammogram within 12 months of the first reminder, a booster intervention ( I.E.a reminder letter will be sent requesting that they call in to schedule a mammogram. The letter reminds her that her PCP recommends she get a mammogram. Those who do not respond within 7 days, will receive a scheduler call) will be repeated as necessary for up to 3 times.
Counselor CallBehavioural
Also called educator call
Reminder letter s as above is sent. If subject does not call in to schedule within 2 weeks, second letter is sent with mammography educational booklet. Second letter reiterates reminder that PCP recommends screening. Has number to call to schedule. If subject does not schedule within 2 weeks, counselor will call. Protocol script includes tailored barriers counseling, correction of misinformation and motivational interviewing techniques. For those who did not complete a mammogram within 12 months of the first reminder, a booster intervention will be repeated annually for up to 3 times as necessary.Booster is reminder letter with pamphlet stressing the 4 reasons why women need regular mammograms.
| Study group | Role | What they receive |
|---|---|---|
| Reminder Letter | A letter sent to women reminding them that are coming due or overdue for a mammogram. It contains a reminder that their primary care provider (PCP) recommends mammography screening every 1-2 years. It urges them to call a special number to a study scheduler to get assistance scheduling a mammogram and is signed electronically by their primary care provider. Repeat "Booster" letters will be sent in subsequent years to those failing to get a mammogram. Receives: Behavioral: Reminder Letter | |
| Reminder Call | A reminder letter (as in the 1st group) is sent. If a woman does not call in to schedule a mammogram within 2 weeks, a study scheduler will call her, remind her she is coming or is overdue, remind her that her PCP recommends screening every 1-2 years and offer to schedule a mammogram for her. Repeat "Booster" letters will be sent and repeat scheduler calls made in subsequent years to those failing to get a mammogram. Receives: Behavioral: Reminder Call | |
| Counselor Call | A reminder letter as above is sent first. If a woman does not call in to schedule a mammogram within 2 weeks, a second letter is sent along with a mammography educational booklet. The second letter also reiterates a reminder that her PCP recommends screening every 1-2 years, and offers a special number to call to schedule. If a woman does not schedule within 8-10 days, a counselor will call. The protocol script included tailored barriers counseling, correction of misinformation and motivational interviewing. Repeat "booster" letters will be sent and repeat counselors calls made in subsequent years to those failing to get a mammogram. techniques. Average calls last 20-30 minutes. Receives: Behavioral: Counselor Call |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of women in each arm who complete a mammogram in the prior 24 months
The outcome will be determined for each of the 4 years of intervention. But the main interest will be the outcome measured in the final intervention year because we believe this best illustrates the magnitude of intervention effect that could be achieved in future years.
Measured: 4 years
Secondary outcomes (3)
A comparison of the number of interventions required per arm
We anticipate that fewer women who receive the ETTC call (Counselor call) will need repeat interventions compared with the women in the reminder call arm or the women in the reminder letter arm.
Measured: 4 years
The percent of women in each arm receiving an intervention who will complete a scheduled mammogram
We anticipate that women who received a counselor (ETTC) call and who scheduled a mammogram on the call will have the highest completion rate compared to women who received a reminder call or a reminder letter.
Measured: 4 years
Evaluation of the effectiveness of booster or repeat interventions in women failing to respond to request for getting a mammogram
The relative effectiveness and cost effectiveness of repeating reminders (letters, calls vs. counseling calls) in women who have not responded to a prior request(s) for completing a mammogram will be studied.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startJul 2009
- Primary completionOct 2014
- Study completionMay 2015
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.
- More trials run by University of Massachusetts, WorcesterThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 36,348 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Reliant Medical Group, Fallon Community Health Plan, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mary E. Costanza, University of Massachusetts, Worcester
- Investigators
- Mary E Costanza, MD, Principal investigator, UMass Medical School and Reliant Medical Group (formerly called Fallon Clinic)Roger Luckmann, MD, MPH, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332032
- Sponsor's protocol ID
- FCM001
- Other IDs
- R01CA132935
- Status last verified
- May 2015
- First submitted
- 7 Apr 2011
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Costanza ME, Luckmann R, White MJ, Rosal MC, Cranos C, Reed G, Clark R, Sama S, Yood R. Design and methods for a randomized clinical trial comparing three outreach efforts to improve screening mammography adherence. BMC Health Serv Res. 2011 Jun 3;11:145. doi: 10.1186/1472-6963-11-145.
PubMed 21639900
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Breast Cancer Screening in Non-adherent Women
- ClinicalTrials.gov ID
- NCT01332032
- Acronym / sponsor ID
- FCM001
- Conditions
- Breast Cancer
- Keywords
- cost effectiveness, screening mammography, repeat mammography, telephone counseling, computerized reminders, compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36,348 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Reliant Medical Group, Fallon Community Health Plan, National Cancer Institute (NCI)
- Study start
- Jul 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 Apr 2011 (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.
This randomized study compares the effectiveness and cost-effectiveness of 3 proven methods of reaching out to women who are coming due for or who are overdue for a mammogram. The study originally embedded in a community healthcare plan and an associated community clinic, now accepts patients using the community clinic and 3 other health care plans. The study makes use of a complex computer driven reminder system.
The study also will examine ways to improve the efficiency and sequencing of the interventions by identifying patient factors associated with intervention effectiveness.
Detailed description
The randomized study compares three interventions. All eligible women are randomly assigned to 1 of 3 interventions. If they become 18 or more months from a prior mammogram, they will receive the intervention to which they were assigned.
The 3 arms are
- RL ARM: (reminder letter) a control arm which consists of a reminder letter only that states when the last mammogram was, contains a standard recommendation from her primary care provider (PCP), and requests that the woman call a special number for help scheduling a mammogram.
- RC ARM: (reminder call) a reminder letter as above, followed, if no response, by a reminder call from a study scheduler who offers to help schedule a mammogram.
- ETTC ARM: (enhanced tailored telephone counseling call) a reminder letter as above, followed, if no response by a second letter, a mammography educational booklet and a second request to call a special number to schedule a mammogram. If no response, a study counselor/educator will call.
A complex computer-based tracking system identifies women coming due for a mammogram or those overdue for a mammogram. The system interfaces with the clinic database systems and stores information re age, telephone number, address, prior screening dates, primary care provider name, scheduling dates, etc. The system can generate reminder letters as appropriate.
The tracking system also interfaces with computer-assisted telephone script systems(CATI) which prompt the study scheduler or the study counselor to follow the protocol that is tailored to the individual patient.
The CATI system captures data from all calls, including how ready a woman is to schedule, the answers to a brief socio-demographic survey and in the counselor call script barriers and misinformation about mammography.
The computer system also interfaces with the radiology scheduling system so that study personnel can assist women in scheduling a mammogram during the phone call.
The primary outcome is the number of women in each arm getting a mammogram. This data will come from the clinic data base and the healthcare plan billing system.
Secondary outcomes include evaluation of the effect of booster or repeat interventions in women failing to respond to prior request for mammogram.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reminder Letter | – | Behavioral: Reminder LetterA letter sent to women reminding them that are coming due or overdue for a mammogram. It contains a reminder that their primary care provider (PCP) recommends mammography screening every 1-2 years. It urges them to call a special number to a study scheduler to get assistance scheduling a mammogram and is signed electronically by their primary care provider. Repeat "Booster" letters will be sent in subsequent years to those failing to get a mammogram. |
| Reminder Call | – | Behavioral: Reminder CallA reminder letter (as in the 1st group) is sent. If a woman does not call in to schedule a mammogram within 2 weeks, a study scheduler will call her, remind her she is coming or is overdue, remind her that her PCP recommends screening every 1-2 years and offer to schedule a mammogram for her. Repeat "Booster" letters will be sent and repeat scheduler calls made in subsequent years to those failing to get a mammogram. |
| Counselor Call | – | Behavioral: Counselor CallA reminder letter as above is sent first. If a woman does not call in to schedule a mammogram within 2 weeks, a second letter is sent along with a mammography educational booklet. The second letter also reiterates a reminder that her PCP recommends screening every 1-2 years, and offers a special number to call to schedule. If a woman does not schedule within 8-10 days, a counselor will call. The protocol script included tailored barriers counseling, correction of misinformation and motivational interviewing. Repeat "booster" letters will be sent and repeat counselors calls made in subsequent years to those failing to get a mammogram. techniques. Average calls last 20-30 minutes. |
Who may qualify
- Ages
- 40 to 84 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 40 to 84 who have life expectancy of five years, have at least one breast, and who have been cared for by Fallon Community Health Plan and currently cared for by Reliant Medical Group (formerly called Fallon Clinic) PCP. Interventions directed at women who are at least 18 months from prior mammogram. Since July 2012, patients with a current Reliant Medical Group PCP who have been enrolled in Blue Cross/Bluse Shield, Harvard Pilgrim or Tufts health plans for 18 months may be eligible for enrollment.
Key inclusion criteria (4 listed)
- women aged 40 through 84 years old
- in the Fallon Community Health Plan, Blue Cross, Tufts or Harvard Pilgrim health plans for 18 or more months
- has a current Reliant Medical Group (formerly called Fallon Clinic) primary care provider
- has working telephone
Key exclusion criteria (4 listed)
- significant cognitive impairment
- serious illness, precluding screening
- bilateral mastectomy
- life expectancy less than 5 years
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 |
|---|---|---|
| Reminder LetterAlso: mammography reminder letter.A letter sent to women reminding them that they are coming due or overdue for a mammogram. It contains a reminder that their doctor recommends mammography screening every 1-2 years; urges them to call a special number to a study scheduler to get assistance scheduling a mammogram and is signed electronically by their primary care provider. For women in the reminder letter only arm, who did not complete a mammogram within 12 months of the first reminder, a booster intervention (I.E. reminder letter) will be sent. The letter requests that a woman call in to schedule a mammogram, and reminds her that her PCP recommends she get one. Booster letters will be sent up to three times at annual intervals for those failing to get a mammogram | Behavioural | Reminder Letter |
| Reminder CallAlso: mammography phone callA reminder letter (as in the 1st group) is sent. If a woman does not call in to schedule a letter, 2 weeks later, a study scheduler will call her, remind her she is coming or is overdue, remind her that her PCP recommends screening every 1-2 years and offers to schedule a mammogram for her. For women in the reminder letter arm who did not complete a mammogram within 12 months of the first reminder, a booster intervention ( I.E.a reminder letter will be sent requesting that they call in to schedule a mammogram. The letter reminds her that her PCP recommends she get a mammogram. Those who do not respond within 7 days, will receive a scheduler call) will be repeated as necessary for up to 3 times. | Behavioural | Reminder Call |
| Counselor CallAlso: educator callReminder letter s as above is sent. If subject does not call in to schedule within 2 weeks, second letter is sent with mammography educational booklet. Second letter reiterates reminder that PCP recommends screening. Has number to call to schedule. If subject does not schedule within 2 weeks, counselor will call. Protocol script includes tailored barriers counseling, correction of misinformation and motivational interviewing techniques. For those who did not complete a mammogram within 12 months of the first reminder, a booster intervention will be repeated annually for up to 3 times as necessary.Booster is reminder letter with pamphlet stressing the 4 reasons why women need regular mammograms. | Behavioural | Counselor Call |
Primary outcome
The proportion of women in each arm who complete a mammogram in the prior 24 months
Time frame: 4 years
The outcome will be determined for each of the 4 years of intervention. But the main interest will be the outcome measured in the final intervention year because we believe this best illustrates the magnitude of intervention effect that could be achieved in future years.
3 secondary outcomes
A comparison of the number of interventions required per arm
Time frame: 4 years
The percent of women in each arm receiving an intervention who will complete a scheduled mammogram
Time frame: 4 years
Evaluation of the effectiveness of booster or repeat interventions in women failing to respond to request for getting a mammogram
Time frame: 4 years
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 1 Jun 2015.
- Background: PubMed 21639900Costanza ME, Luckmann R, White MJ, Rosal MC, Cranos C, Reed G, Clark R, Sama S, Yood R. Design and methods for a randomized clinical trial comparing three outreach efforts to improve screening mammography adherence. BMC Health Serv Res. 2011 Jun 3;11:145. doi: 10.1186/1472-6963-11-145.
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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.
Mary E Costanza, MD principal investigator
UMass Medical School and Reliant Medical Group (formerly called Fallon Clinic)
Roger Luckmann, MD, MPH principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Massachusetts, Worcester at 1 site in United States.
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 4 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 1 Jun 2015. 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 United States. 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?
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?
The proportion of women in each arm who complete a mammogram in the prior 24 months (time frame: 4 years). 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 NCT01332032, 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 1 Jun 2015.