Breast CancerNCT01148875
Mammography Reminders for Encouraging Women to Undergo Regular Mammography Screenings for Breast Cancer
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center.
Trial summary
RATIONALE: Mammography reminders may encourage women to undergo regular mammography screenings for breast cancer. PURPOSE: This randomized clinical trial is studying three different mammography reminder interventions to compare how well they work in encouraging women to undergo regular mammography screenings for… Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mammography appointment reminders; telephone counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,547 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Oct 2010
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women members of The North Carolina Teachers' and State Employees' Comprehensive Major Medical Plan (SHP) who are age 40-75. They must be enrolled with the SHP for at least 24 months, not covered by COBRA or Medicare primary. Based on claims data, women will have had their last mammogram 6-8 months ago.
Who may be able to join
- Women members of The North Carolina Teachers' and State Employees' Comprehensive Major Medical Plan (SHP)
- Age 40-75
- Enrolled with the SHP for at least 24 months, not covered by COBRA or Medicare primary
- Based on claims data, women will have had their last mammogram 6-8 months ago so reminders will arrive 2 months prior to due date for next mammogram.
Who cannot join
- Unable to speak and understand English. We lack the resources to adapt the intervention appropriate for non-English speakers. Moreover, we do not know if the interventions lend themselves to cultural translation. We regard this as a next logical research activity.
- Have breast cancer or have some other illness that precludes participation. Women diagnosed with breast cancer before the study are ineligible; their screening schedules are consistent with recommendations for the general population. However, if women develop breast cancer during the study, we would ask them a reduced set of questions.
- We selected age 75 as the upper limit, because there are too few women over age 75 to permit meaningful statistical analysis (<100 women in all). The SHP is largely a working population. We wish that it were possible both to include and analyze women older than age 75. This is a limitation of the population we have selected.
About this study
Official title: Finding the M.I.N.C. for Mammography Maintenance
RATIONALE: Mammography reminders may encourage women to undergo regular mammography screenings for breast cancer.
PURPOSE: This randomized clinical trial is studying three different mammography reminder interventions to compare how well they work in encouraging women to undergo regular mammography screenings for breast cancer.
Read the detailed description
OBJECTIVES:
- Compare the effectiveness of mammography reminder interventions using usual care reminder vs enhanced automated phone reminder vs enhanced letter reminder in increasing the proportion of women who undergo annual mammograms as recommended by medical organizations.
- Compare the impact of alternative delivery channels (mail vs automated phone reminders) and enhanced messages in facilitating maintenance of mammography in these participants.
- Determine the incremental benefit of adding a consequence elaboration component to barriers-specific telephone counseling in encouraging these participants to regain adherence to mammography.
- Determine the minimum intervention needed for change to ensure annual mammography and maintenance in participants.
OUTLINE: This is a randomized, controlled study. Participants are randomized to 1 of 3 arms.
- Arm I: Participants receive a usual care mammography reminder by telephone annually for 4 years.
- Arm II: Participants receive an enhanced automated phone mammography reminder annually for 4 years.
- Arm III: Participants receive an enhanced letter mammography reminder annually for 4 years.
Insurance claims reports and patients' self reports as to whether or not they subsequently underwent mammography are examined. Patients who do not undergo mammography within 6 months after receiving a reminder are further randomized to 1 of 4 arms.
- Arm I: Participants receive no further reminders until the next annual reminder.
- Arm II: Participants receive an enhanced Barriers-Specific Counseling Call (BarriConCall) annually for 4 years that focuses on positive consequences of undergoing mammography.
- Arm III: Participants receive an enhanced BarriConCall annually for 4 years that focuses on negative consequences of not undergoing mammography.
- Arm IV: Participants receive a standard barrier call (BarriCall) annually for 4 years.
PROJECTED ACCRUAL: A total of 4,040 participants (1,000 for usual care mammography reminder; 1,520 for enhanced automated phone mammography reminder; and 1,520 for enhanced letter mammography reminder) will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- Mammography appointment reminders; telephone counseling
- Keywords
- breast cancer screening, mammography adherence, non-adherent
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammography appointment reminders; telephone counselingBehavioural
Also called Usual Care Reminder(UCR), Enhanced Automated Phone Reminder (EAPR), Enhanced Letter Reminder (ELR), Priming Letter (PL)
Women randomly assigned to UCR, EAPR, ELR; repeated 4 times at yearly intervals. Using claims data, supplemented by self-report, verified if women had recent mammograms. Women who remained non-adherent after reminders received Barriers-Specific Telephone Counseling Call, or an enhanced call including focus on either positive or negative consequences of getting/not getting mammograms. Prior to calls, women in each of the three phone counseling groups received priming letters to prime them to process information in the call. Priming letters should prepare women to process information from subsequent counseling calls more deeply by focusing on the positive or negative consequences of getting/not getting mammograms or on identifying and overcoming their own barriers to being screened.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammography Adherence
The primary study objective was to identify the minimal intervention needed for sustained mammography adherence over 4 years. Average cumulative number of days non-adherent to mammography over 4 years based on annual screening guidelines. Claims data (monthly mammography claims information were reviewed to determine women's adherence status) and self-report (during annual telephone interviews, women were asked to confirm dates of their most recent and prior mammograms, based on claims data) were used to determine dates of screening.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startSep 2004
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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 UNC Lineberger Comprehensive Cancer CenterThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,547 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Barbara K. Rimer, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148875
- Sponsor's protocol ID
- UNC-03-2104
- Other IDs
- R01CA105786, P30CA016086, CDR0000438777
- Status last verified
- Jan 2016
- First submitted
- 21 Jun 2010
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lipkus, I.M., Klein, W.M.P., Skinner, C.S., Rimer, B.K. (2005) Breast Cancer Risk Perceptions and Breast Cancer Worry: What Predicts What? Journal of Risk Research, 8(5): 439-452.
Rimer BK, Gierisch JM. Public education and cancer control. Semin Oncol Nurs. 2005 Nov;21(4):286-95. doi: 10.1016/j.soncn.2005.06.003.
PubMed 16293517Rimer, B.K. and Kreuter, M.W. (2006). Advancing Tailored Health Communication: A Persuasion and Message Effects Perspective. Journal of Communication, (56): S184-S201.
Gierisch JM, Reiter PL, Rimer BK, Brewer NT. Standard definitions of adherence for infrequent yet repeated health behaviors. Am J Health Behav. 2010 Nov-Dec;34(6):669-79. doi: 10.5993/ajhb.34.6.4.
PubMed 20604693DeFrank JT, Bowling JM, Rimer BK, Gierisch JM, Skinner CS. Triangulating differential nonresponse by race in a telephone survey. Prev Chronic Dis. 2007 Jul;4(3):A60. Epub 2007 Jun 15.
PubMed 17572964O'Neill SC, Bowling JM, Brewer NT, Lipkus IM, Skinner CS, Strigo TS, Rimer BK. Intentions to maintain adherence to mammography. J Womens Health (Larchmt). 2008 Sep;17(7):1133-41. doi: 10.1089/jwh.2007.0600.
PubMed 18657041DeFrank JT, Rimer BK, Gierisch JM, Bowling JM, Farrell D, Skinner CS. Impact of mailed and automated telephone reminders on receipt of repeat mammograms: a randomized controlled trial. Am J Prev Med. 2009 Jun;36(6):459-67. doi: 10.1016/j.amepre.2009.01.032. Epub 2009 Apr 11.
PubMed 19362800Gierisch JM, O'Neill SC, Rimer BK, DeFrank JT, Bowling JM, Skinner CS. Factors associated with annual-interval mammography for women in their 40s. Cancer Epidemiol. 2009 Jul;33(1):72-8. doi: 10.1016/j.cdp.2009.03.001. Epub 2009 May 29.
PubMed 19481879Gierisch JM, DeFrank JT, Bowling JM, Rimer BK, Matuszewski JM, Farrell D, Skinner CS. Finding the minimal intervention needed for sustained mammography adherence. Am J Prev Med. 2010 Oct;39(4):334-44. doi: 10.1016/j.amepre.2010.05.020.
PubMed 20837284Gierisch JM, Earp JA, Brewer NT, Rimer BK. Longitudinal predictors of nonadherence to maintenance of mammography. Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1103-11. doi: 10.1158/1055-9965.EPI-09-1120. Epub 2010 Mar 30.
PubMed 20354125Mier N, Ory MG, Toobert DJ, Smith ML, Osuna D, McKay JR, Villarreal EK, DiClemente RJ, Rimer BK. A qualitative case study examining intervention tailoring for minorities. Am J Health Behav. 2010 Nov-Dec;34(6):822-32.
PubMed 20604705O'Neill SC, Lipkus IM, Gierisch JM, Rimer BK, Bowling JM. It's the amount of thought that counts: when ambivalence contributes to mammography screening delay. Womens Health Issues. 2012 Mar;22(2):e189-94. doi: 10.1016/j.whi.2011.08.008. Epub 2011 Nov 3.
PubMed 22055988
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding the M.I.N.C. for Mammography Maintenance
- ClinicalTrials.gov ID
- NCT01148875
- Acronym / sponsor ID
- UNC-03-2104
- Conditions
- Breast Cancer
- Keywords
- breast cancer screening, mammography adherence, non-adherent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,547 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2004
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 22 Jun 2010 (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.
RATIONALE: Mammography reminders may encourage women to undergo regular mammography screenings for breast cancer.
PURPOSE: This randomized clinical trial is studying three different mammography reminder interventions to compare how well they work in encouraging women to undergo regular mammography screenings for breast cancer.
Detailed description
OBJECTIVES:
- Compare the effectiveness of mammography reminder interventions using usual care reminder vs enhanced automated phone reminder vs enhanced letter reminder in increasing the proportion of women who undergo annual mammograms as recommended by medical organizations.
- Compare the impact of alternative delivery channels (mail vs automated phone reminders) and enhanced messages in facilitating maintenance of mammography in these participants.
- Determine the incremental benefit of adding a consequence elaboration component to barriers-specific telephone counseling in encouraging these participants to regain adherence to mammography.
- Determine the minimum intervention needed for change to ensure annual mammography and maintenance in participants.
OUTLINE: This is a randomized, controlled study. Participants are randomized to 1 of 3 arms.
- Arm I: Participants receive a usual care mammography reminder by telephone annually for 4 years.
- Arm II: Participants receive an enhanced automated phone mammography reminder annually for 4 years.
- Arm III: Participants receive an enhanced letter mammography reminder annually for 4 years.
Insurance claims reports and patients' self reports as to whether or not they subsequently underwent mammography are examined. Patients who do not undergo mammography within 6 months after receiving a reminder are further randomized to 1 of 4 arms.
- Arm I: Participants receive no further reminders until the next annual reminder.
- Arm II: Participants receive an enhanced Barriers-Specific Counseling Call (BarriConCall) annually for 4 years that focuses on positive consequences of undergoing mammography.
- Arm III: Participants receive an enhanced BarriConCall annually for 4 years that focuses on negative consequences of not undergoing mammography.
- Arm IV: Participants receive a standard barrier call (BarriCall) annually for 4 years.
PROJECTED ACCRUAL: A total of 4,040 participants (1,000 for usual care mammography reminder; 1,520 for enhanced automated phone mammography reminder; and 1,520 for enhanced letter mammography reminder) will be accrued for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women members of The North Carolina Teachers' and State Employees' Comprehensive Major Medical Plan (SHP) who are age 40-75. They must be enrolled with the SHP for at least 24 months, not covered by COBRA or Medicare primary. Based on claims data, women will have had their last mammogram 6-8 months ago.
Key inclusion criteria (4 listed)
- Women members of The North Carolina Teachers' and State Employees' Comprehensive Major Medical Plan (SHP)
- Age 40-75
- Enrolled with the SHP for at least 24 months, not covered by COBRA or Medicare primary
- Based on claims data, women will have had their last mammogram 6-8 months ago so reminders will arrive 2 months prior to due date for next mammogram.
Key exclusion criteria (3 listed)
- Unable to speak and understand English. We lack the resources to adapt the intervention appropriate for non-English speakers. Moreover, we do not know if the interventions lend themselves to cultural translation. We regard this as a next logical research activity.
- Have breast cancer or have some other illness that precludes participation. Women diagnosed with breast cancer before the study are ineligible; their screening schedules are consistent with recommendations for the general population. However, if women develop breast cancer during the study, we would ask them a reduced set of questions.
- We selected age 75 as the upper limit, because there are too few women over age 75 to permit meaningful statistical analysis (<100 women in all). The SHP is largely a working population. We wish that it were possible both to include and analyze women older than age 75. This is a limitation of the population we have selected.
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 |
|---|---|---|
| Mammography appointment reminders; telephone counselingAlso: Usual Care Reminder(UCR), Enhanced Automated Phone Reminder (EAPR), Enhanced Letter Reminder (ELR), Priming Letter (PL)Women randomly assigned to UCR, EAPR, ELR; repeated 4 times at yearly intervals. Using claims data, supplemented by self-report, verified if women had recent mammograms. Women who remained non-adherent after reminders received Barriers-Specific Telephone Counseling Call, or an enhanced call including focus on either positive or negative consequences of getting/not getting mammograms. Prior to calls, women in each of the three phone counseling groups received priming letters to prime them to process information in the call. Priming letters should prepare women to process information from subsequent counseling calls more deeply by focusing on the positive or negative consequences of getting/not getting mammograms or on identifying and overcoming their own barriers to being screened. | Behavioural | – |
Primary outcome
Mammography Adherence
Time frame: 12 months
The primary study objective was to identify the minimal intervention needed for sustained mammography adherence over 4 years. Average cumulative number of days non-adherent to mammography over 4 years based on annual screening guidelines. Claims data (monthly mammography claims information were reviewed to determine women's adherence status) and self-report (during annual telephone interviews, women were asked to confirm dates of their most recent and prior mammograms, based on claims data) were used to determine dates of screening.
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 20 Jan 2016.
- BackgroundLipkus, I.M., Klein, W.M.P., Skinner, C.S., Rimer, B.K. (2005) Breast Cancer Risk Perceptions and Breast Cancer Worry: What Predicts What? Journal of Risk Research, 8(5): 439-452.
- Background: PubMed 16293517Rimer BK, Gierisch JM. Public education and cancer control. Semin Oncol Nurs. 2005 Nov;21(4):286-95. doi: 10.1016/j.soncn.2005.06.003.
- BackgroundRimer, B.K. and Kreuter, M.W. (2006). Advancing Tailored Health Communication: A Persuasion and Message Effects Perspective. Journal of Communication, (56): S184-S201.
- Background: PubMed 20604693Gierisch JM, Reiter PL, Rimer BK, Brewer NT. Standard definitions of adherence for infrequent yet repeated health behaviors. Am J Health Behav. 2010 Nov-Dec;34(6):669-79. doi: 10.5993/ajhb.34.6.4.
- Results publication: PubMed 17572964DeFrank JT, Bowling JM, Rimer BK, Gierisch JM, Skinner CS. Triangulating differential nonresponse by race in a telephone survey. Prev Chronic Dis. 2007 Jul;4(3):A60. Epub 2007 Jun 15.
- Results publication: PubMed 18657041O'Neill SC, Bowling JM, Brewer NT, Lipkus IM, Skinner CS, Strigo TS, Rimer BK. Intentions to maintain adherence to mammography. J Womens Health (Larchmt). 2008 Sep;17(7):1133-41. doi: 10.1089/jwh.2007.0600.
- Results publication: PubMed 19362800DeFrank JT, Rimer BK, Gierisch JM, Bowling JM, Farrell D, Skinner CS. Impact of mailed and automated telephone reminders on receipt of repeat mammograms: a randomized controlled trial. Am J Prev Med. 2009 Jun;36(6):459-67. doi: 10.1016/j.amepre.2009.01.032. Epub 2009 Apr 11.
- Results publication: PubMed 19481879Gierisch JM, O'Neill SC, Rimer BK, DeFrank JT, Bowling JM, Skinner CS. Factors associated with annual-interval mammography for women in their 40s. Cancer Epidemiol. 2009 Jul;33(1):72-8. doi: 10.1016/j.cdp.2009.03.001. Epub 2009 May 29.
- Results publication: PubMed 20837284Gierisch JM, DeFrank JT, Bowling JM, Rimer BK, Matuszewski JM, Farrell D, Skinner CS. Finding the minimal intervention needed for sustained mammography adherence. Am J Prev Med. 2010 Oct;39(4):334-44. doi: 10.1016/j.amepre.2010.05.020.
- Results publication: PubMed 20354125Gierisch JM, Earp JA, Brewer NT, Rimer BK. Longitudinal predictors of nonadherence to maintenance of mammography. Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1103-11. doi: 10.1158/1055-9965.EPI-09-1120. Epub 2010 Mar 30.
- Results publication: PubMed 20604705Mier N, Ory MG, Toobert DJ, Smith ML, Osuna D, McKay JR, Villarreal EK, DiClemente RJ, Rimer BK. A qualitative case study examining intervention tailoring for minorities. Am J Health Behav. 2010 Nov-Dec;34(6):822-32.
- Results publication: PubMed 22055988O'Neill SC, Lipkus IM, Gierisch JM, Rimer BK, Bowling JM. It's the amount of thought that counts: when ambivalence contributes to mammography screening delay. Womens Health Issues. 2012 Mar;22(2):e189-94. doi: 10.1016/j.whi.2011.08.008. Epub 2011 Nov 3.
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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.
Barbara K. Rimer, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center.
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 3 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Mammography Adherence (time frame: 12 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 NCT01148875, which also lists 12 linked publications.
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 20 Jan 2016.