Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Standard Reminder Postcard

Family Physician Reminder Letter

Alan Nichol, MD

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.

A Randomized Trial of Letters From Family Physicians to Encourage Screening Mammography in Overdue Women

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

Percentage of overdue women returning for screening mammography, measured from the date of randomization

Canadian Breast Cancer Foundation

British Columbia Cancer Agency

Radiation Oncologist

Control Arm

Mail

Standard Reminder Postcard

Family Physician Reminder Letter

Family Physician Reminder Letter Arm

Total

Age, Customized

Sex: Female, Male

Canada

Region of Enrollment

Total includes patients who were screened before randomization

Dr. Alan Nichol

Percentage of Overdue Women Returning for Screening Mammography

Overall Study

Breast Diseases

Skin Diseases

All non-adherent women were offered inpatient screening mammography during hospitalization

The purpose of the study was to evaluate the feasibility of securing inpatient breast cancer screening mammograms for non-adherent hospitalized women prior to hospital discharge.

Screening mammography

Waseem Khaliq, MD

The investigators propose to pilot a program that will evaluate the feasibility of an inpatient screening mammography for non-adherent and high risk hospitalized women age 52-74 admitted to the medicine services at Johns Hopkins Bayview Medical Center and Howard County General Hospital. The two key activities include: inpatient breast care education with educational handouts and offering inpatient screening mammography. Inpatient screening mammography will be offered to non-adherent (last screening mammogram more than 24 months ago) and high risk (Gail 5-year risk of breast cancer 1.6 or greater) women. This pilot program will thus evaluate the feasibility of an inpatient screening mammography as an innovative approach to increase breast cancer screening among non-adherent and high risk women.

women between 50 and 74 years of age who were non-adherent to breast screening guidelines (USPSTF recommendations)

Inpatient Screening Mammography for Non-adherent and High Risk Women

Screening mammography is done during hospitalization. Proportion of women that get the screening will be assessed.

Maryland Cigarette Restitution Fund

EQUIP (Excellence in Quality, Utilization of resources, Integration and Patient- centered Care)

Johns Hopkins University

Normal screening mammogram (BIRADS 1 or 2)

Abnormal screening mammogram (BIRADS 3 to 6)

Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.

BreathX test for breath VOCs

Michael Phillips, MD

Jonah Phillips, MBA

Peter Fasching, MD

Hanna Huebner

Marc Lobbes, MD

Alexandra Tenovici, MD

Alexandra Tenovici

To validate a breath test that predicts risk of breast cancer and an abnormal mammogram.

We will determine the accuracy of volatile organic compounds (VOCs) in the breath as predictors of risk of breast cancer and an abnormal mammogram. Breath samples will be collected using an ultra-clean collection bag and analyzed with gas chromatography surface acoustic wave detection (GC SAW)

The study will be performed in two phases:

Phase 1: Model-building phase (cross-sectional study): Breath VOCs will be employed to construct multivariate algorithms that distinguish between normal women and those with breast cancer and abnormal screening mammograms.

Phase 2: Model-testing phase (cross-sectional study): The predictive accuracy of these algorithms will be tested to predict outcomes in normal women and those with breast cancer and abnormal screening mammograms.

Breath Test to Predict Breast Cancer and Outcome of Mammography

Determination of the sensitivity, specificity, and positive and negative predictive values of a breath test for biomarkers that predict the risk of an abnormal mammogram.

Determination of the sensitivity, specificity, and positive and negative predictive values of a breath test for biomarkers that predict the risk of an biopsy-proven breast cancer

Mount Vernon Cancer Centre

Zuyderland Medical Centre

University of Erlangen-Nürnberg

Menssana Research, Inc.

Carcinoma

All Drugs and Chemicals

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Hormones

Aspirin

Participants provide bilateral screening mammogram taken prior to all cancer treatment and within 8 weeks prior to registration to A011502 and an annual bilateral mammogram as near as possible to 1 year post-registration to A011502 and as near as possible to 2 years post-registration to A011502. Participants also undergo collection of blood sample and menstrual cycle data within 2 weeks after registration and at 1 and 2 years after registration to A011502.

Screening Mammography

Biospecimen Collection

Marie Wood, MD

This phase III trial evaluates mammographic breast density in participants with hormone receptor-negative breast cancer enrolled on study A011502. High breast density has been shown to be a strong risk factor for developing breast cancer and decreasing breast density may decrease the risk for breast cancer. Participants treated with aspirin may show reduced breast density on a mammogram.

PRIMARY OBJECTIVES I. To compare the 1-year mammographic breast density in the contralateral (unaffected) breast between the aspirin and placebo arms in patients with hormone receptor negative or positive breast cancer enrolled in A011502.

SECONDARY OBJECTIVES I. To compare the 2-year mammographic breast density in the contralateral (unaffected) breast between the aspirin and placebo arms in patients with hormone receptor negative or positive breast cancer enrolled in A011502.

OUTLINE:

Participants provide bilateral screening mammogram taken prior to all cancer treatment and within 8 weeks prior to registration to A011502 and an annual bilateral mammogram as near as possible to 1 year post-registration to A011502 and as near as possible to 2 years post-registration to A011502. Participants also undergo collection of blood sample and menstrual cycle data within 2 weeks after registration and at 1 and 2 years after registration to A011502.

After completion of study, participants are followed up annually until 10 years from registration to study A011502.

Evaluation of Mammographic Breast Density in Participants With Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502

Evaluation of Mammographic Breast Density Effect of Aspirin: A Companion Study to Alliance Study A011502

The 1-year mammographic percent density (MPD) in the contralateral (unaffected) breast between the aspirin and placebo arms will be compared. Analysis of covariance (ANCOVA) adjusting for baseline MPD will be used to compare MPD at 1 year between the arms. After adjusting for the baseline MPD, it will be concluded that the 1-year MPD is statistically different between the two arms if the corresponding two-sided p-value is less than 0.05. If normality of the primary variable is questionable, then variable transformation or nonparametric Wilcoxon rank-sum test on simple change MPD values may be considered as alternative approaches. A subsequent exploratory analysis will include all patients with an MPD computed at baseline (regardless of that baseline value) and at 1-year post-baseline.

The 2-year mammographic breast density in the contralateral (unaffected) breast between the two arms for those patients with a baseline mammographic percent density (MPD) \>= 25% and a 2-year post-baseline MPD will be compared. ANCOVA will be used to compare MPD between the arms. The corresponding test for the between-arm difference in MPD at 2-years will also be carried out at the 0.05 significance level.

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard of care protocol.

Immediately following consent and completion of the baseline assessment, women in the intervention arm 1 will participate in a 20-30 minute educational session alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.

Immediately following consent and completion of the baseline assessment, women in the intervention arm will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.

Immediately following consent and completion of the baseline assessment, alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.

Mammography with Community Health Worker (individual)

Mammography with Community Health Worker (group)

Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard protocol.

Standard of Care Mammography

Lucy Spalluto, MD

Although there has been interval improvement in reducing disparity in mammography utilization in medically underserved communities since the 1990s, significant disparities persist and should be addressed. In the 40-65 year old age range, there is significant disparity in screening mammography utilization in Hispanic women compared to their white counterparts.

Culturally adapted patient-targeted healthcare interventions can help reduce ethnic inequalities in access to cancer screening programs. Promotoras, culturally appropriate patient navigators for the Hispanic community, have been shown to increase screening mammography rates in the Hispanic/Latino population.

However, there is little research exploring the interaction between these lay community health workers and community members. This proposal aims to assess this interaction by measuring the impact of a Promotora working with community members in either a group setting or individual setting. Understanding this interaction can lead to more effectively designed future community interventions. Primary outcomes in this study will include women's reported measures of interpersonal processes of care (communication and interpersonal style) during screening mammography care, trust in the healthcare system, and satisfaction with cancer screening care when compared to those receiving standard of care.

Promotora Navigator - Culturally Appropriate Patient Navigator

Assessing the Impact of a Community Health Worker on Hispanic Women's Reported Measures of Processes of Care in the Screening Mammography Setting

Selected scales (communication and interpersonal style) of the Interpersonal Processes of Care Survey will be the primary outcome. A total of 18 (corrected from orginal submission) questions will be administered. The questions are scored on a scale from 1-5 with higher scores indicating higher frequencies of the construct. The compiled scores will range from 5-90. Scales with negative associations (discrimination, hurried communication) will be reversed. Thus, higher scores for all items will indicate a more positive experience.

Distrust will be measured with the Revised Healthcare System Distrust Scale. This 9 question scale is divided into two subscales: competence and values. The questions are scored on a scale from 1-5. The total score will range 5-45, with higher scores indicating higher levels of trust. Baseline distrust measured at time of initial consent/screening. Post-intervention distrust measured at time of post-survey which took place approximately 2 weeks after screening (varied as to when patient could be reached for survey). Difference in distrust is subtracts the baseline score from the post score.

Satisfaction with care will be measured with the Patient Satisfaction with Cancer-Related Care (PSCC) Measure. This is an 18 question measure. The questions are scored on a scale from 1-5. The total score will range 5-90, higher scores indicate higher satisfaction with care.

Vanderbilt University Medical Center

Assistant Professor

Mammography With Community Health Worker (Individual)

Immediately following consent and completion of the baseline assessment, women in the intervention arm 2 will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.

Mammography With Community Health Worker (Group)

Age, Continuous

Ethnicity (NIH/OMB)

United States

Dr. Lucy Spalluto

Patient Reported Measures From Interpersonal Processes of Care Survey

Pre intervention

Post Intervention

Patient Reported Measures From the Distrust in the Healthcare System Scale. Reported at Baseline and Post Intervention. Also Reported as the Change Between Baseline and Intervention.

Patient Reported Measures From the Satisfaction With Cancer Related Care Scale.

Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard of care protocol.

Standard of Care Mammography: Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard protocol.

Women who meet criteria for supplemental screening MRI, but who are unable to have MRI for medical/access/cost reasons, will be invited to have screening with contrast-enhanced mammography. Women will also have standard-of-care mammography/tomosynthesis per usual clinical practice.

supplemental breast cancer screening with contrast-enhanced mammography

Contrast-enhanced mammography

Iodinated Contrast Media (ICM)

Wendie Berg, MD, PhD

There are women for whom a screening breast MRI is clinically recommended, but not feasible either due to patient factors (body habitus, pacemaker or other implant, claustrophobia) or access (cost, other constraints). Contrast-enhanced mammography (CEM) is a potential alternative to MRI for screening that uses updated standard mammography equipment to obtain low- and high-energy images after intravenous injection of iodinated contrast (as used in CT scanning). The investigators seek to validate screening CEM as an alternative to screening MRI.

This is a prospective study designed to evaluate the role of contrast enhanced mammography (CEM) in screening for breast cancer. The overarching goal of the research program is to improve cancer detection on screening, particularly in women with dense breasts. MRI depicts more cancers than other screening methods, including ultrasound. MRI is proven to both improve cancer detection and reduce clinically detected cancers ("interval cancers") after a negative screening mammogram in women with dense breasts. PA Senate Bill 595, signed into law June 30, 2020, requires insurance carriers to provide coverage for supplemental screening with MRI or ultrasound for a variety of indications. Relative to the number of women who may benefit from screening MRI, there is a shortage of equipment/capacity. Further, nearly half of women cannot have an MRI for medical or other reasons, such as claustrophobia, implanted devices, body habitus, or cost (deductible and copay apply even with the new legislation). Contrast-enhanced mammography (CEM) appears to have similar performance to MRI but has not been widely validated, particularly for screening. In order to lay the foundation for improved screening of women with dense breasts, the investigators seek to offer screening CEM as an alternative to MRI for women who meet guidelines for screening MRI but are unable to have MRI.

Screening Contrast-Enhanced Mammography as an Alternative to MRI

Images may be shared with secondary investigators, including commercial companies after removal of all identifiers. All patient identification (name, patient number, birth date) will be removed from the DICOM headers of the images.

To show significantly improved cancer detection with CEM compared to standard mammography/tomosynthesis

To show acceptably low false positive recall rates from CEM.

PA Breast Cancer Coalition

Wendie Berg

Professor, Department of Radiology, Breast Imaging Division

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.

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.

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.

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 Letter

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.

Reminder 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.

Counselor Call

Mary E Costanza, MD

Roger Luckmann, MD, MPH

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.

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

1. 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.
2. 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.
3. 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.

Promoting Breast Cancer Screening in Non-adherent Women

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Trial of Letters From Family Physicians to Encourage Screening Mammography in Overdue Women	NCT02660788	Breast Cancer	Standard Remind... Family Physicia...	51 Years - 73 Years	British Columbia Cancer Agency
Inpatient Screening Mammography for Non-adherent and High Risk Women	NCT04164251	Breast Cancer	Screening mammo...	50 Years - 74 Years	Johns Hopkins University
Breath Test to Predict Breast Cancer and Outcome of Mammography	NCT04755829	Breast Cancer Abnormal Mammog...	BreathX test fo...	18 Years -	Menssana Research, Inc.
Evaluation of Mammographic Breast Density in Participants With Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502	NCT03609021	Breast Carcinom... Estrogen Recept... Progesterone Re...	Screening Mammo... Biospecimen Col...	-	Alliance for Clinical Trials in Oncology
Promotora Navigator - Culturally Appropriate Patient Navigator	NCT03557801	Breast Cancer Screening Mammo... Community Healt...	Mammography wit... Mammography wit... Standard of Car...	40 Years - 64 Years	Vanderbilt University Medical Center
Promotora Navigator - Culturally Appropriate Patient Navigator	NCT03557801	Breast Cancer Screening Mammo... Community Healt...	Mammography wit... Mammography wit... Standard of Car...	40 Years - 64 Years	Vanderbilt University Medical Center
Screening Contrast-Enhanced Mammography as an Alternative to MRI	NCT04764292	Breast Cancer	Contrast-enhanc... Iodinated Contr...	30 Years - 75 Years	University of Pittsburgh
Breath Test to Predict Breast Cancer and Outcome of Mammography	NCT04755829	Breast Cancer Abnormal Mammog...	BreathX test fo...	18 Years -	Menssana Research, Inc.
Promoting Breast Cancer Screening in Non-adherent Women	NCT01332032	Breast Cancer	Reminder Letter Reminder Call Counselor Call	40 Years - 84 Years	University of Massachusetts, Worcester

Spots Global Cancer Trial Database for screening mammography