Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks

Empowerment

Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks

Education

Yamile Molina, PhD

The participatory-based project will quantify the 'added benefit' of an empowerment intervention relative to an education intervention for 150 Latinas on the following outcomes: women's adherence to breast cancer screening guidelines; women's psychosocial facilitators (self-efficacy, norms, support, and knowledge); and women's dissemination of breast health messages throughout their social network. The empowerment intervention will train Latinas in how to discuss breast health with their family and friends and volunteer in local breast health promotion programs. Academic, clinician, and community partners will work together throughout intervention development and evaluation.

Latinas suffer disproportionately from breast cancer relative to non-Latina Whites (NLWs), including late stage detection. While there have been controversies in breast cancer screening, non-adherence to guideline-concordant screening continues to be a major modifiable determinant of breast cancer outcome disparities. Thus, increasing participation in breast cancer screening among Latinas, especially care that corresponds with clinical and academic guidelines, is a public health priority. Participatory approaches are popular methods to improve screening within this group and have included approaches that 1) deliver education to non-adherent Latinas and 2) train community health advocates (community health workers, breast cancer survivors) to engage in breast health promotion. The second approach (empowerment interventions) concerns training participants to engage in social outreach (e.g., having conversations with family and friends about breast health) and volunteering (e.g., helping in health fairs, engaging in civic campaigns about breast cancer programs). Patient activation and volunteerism literature suggest that empowerment interventions may have 'added value' for participants themselves over delivering education in terms of preventive health psychosocial factors and practices. Relative to education interventions, empowerment interventions may also affect women's networks, as they may be more likely to disseminate evidence-based breast health promotion among their family and friends. To date, little research has compared interventions' effects on individual-level outcomes or used formal social network analysis to examine network effects. The proposed work adds to the literature through empirically comparing two approaches (education versus empowerment) on three sets of outcomes: 1) women's own screening, 2) women's own self-efficacy, norms, support, knowledge; and 3) women's networks (measured by egocentric analysis). I will lead this work and will benefit from the collective expertise and resources of my mentors (Drs. Ferrans, Mermelstein, Geller) and collaborators (Dr. Schneider, The Resurrection Project, Metropolitan Chicago Breast Cancer Task Force, Sinai Urban Health Institute, University of Illinois Cancer Center). Aim 1 intervention development will be accomplished through continuous stakeholder engagement and specifically through meetings and focus groups with a bilingual, bicultural community advisory engagement board (CEAB), UICC radiologists and target participants (non-adherent Latinas). We have already begun this process and are obtaining formative data. After we develop intervention materials, a pilot trial will be conducted with an area-level treatment control group design in Chicago. Participants will be 150 Latinas with no history of health volunteerism, residence in one of two targeted areas, and non-adherence to US Preventive Services Task Force screening guidelines. Aim 1 intervention evaluation will involve an analysis to compare differences in receipt of a medical record-confirmed screening within six months of participating in the study. Aim 2 will be an analysis to compare interventions' effects on self-efficacy, norms, support, knowledge across three time points - pre-intervention, immediately post-intervention, and six months post-intervention. Aim 3 will be a social network analysis, specifically egocentric, to compare interventions' effects on breast health, network size, and network density as well as will number of peers referred to the study.

Empowering Latinas to Obtain Breast Cancer Screenings

After major study findings have been accepted for publication, Dr. Molina will develop an anonymized data set (i.e., no personally identifiable information) available to qualified scientists upon request. Data will only be made available to scientists who complete a data-sharing agreement that indicates: 1) commitment to using the data only for research purposes and not to identify any individual participant; 2) commitment to securing data using appropriate computer technology; and 3) commitment to destroying or returning the data after analyses are completed.

Total scores/ranges are used. No subscales used. Knowledge - 5 items (Williams et al., 2011). Range for the change scores (baseline to 6-months) is -5 to 5. Higher scores represent a better outcome.

Cultural beliefs - Ferrans cultural beliefs scale (Ferrans et al., 2007). Range for the change scores (baseline to 6-months) is -17 to 17. Higher scores represent a worse outcome.

Breast cancer-specific self-efficacy - Mammography-Specific Self-Efficacy Scale (Champion, Skinner, \& Menon, 2005). Range for the change scores (baseline to 6-months) is -26 to 26. Higher scores represent a better outcome.

Positive breast cancer screening norms - 6 items ( Molina et al., 2015). Range for the change scores (baseline to 6-months) is -12 to 12. Higher scores represent a better outcome.

Breast cancer supportive social network size questions comprised an 8-item version of Berkman-Syme index. Range for the change scores (baseline to 6-months) is -25 to 25. Higher scores represent a better outcome.

This was an open-ended questionnaire, based on the Burt Social Network Instrument. Higher numbers represent better outcomes.

Receipt of mammogram based on medical records and self report within 6 months of baseline survey (Yes or No)

The Resurrection Project

Juan Diego Centro Comunitario

National Cancer Institute (NCI)

University of Illinois at Chicago

Assistant Professor

We used standard definitions of adverse and serious adverse events.

Behavior: Empowerment

Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks

Behavior: Education

Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Insurance

Mammogram 4+ years ago

Mammography intention within next year

There are several limitations to this study, including a small sample, use of non-probability based sampling strategies, and non-randomization.

Dr. Yamile Molina

We conducted logistic regressions, clustering by cohort, given both interventions used a group format, and adjusting for age, education, income, insurance status, baseline mammography history, and baseline mammography intention. The null hypothesis was there would be no study arm differences. A priori power analysis suggested that a sample size of 150, assuming alpha = .05, power = .80 would lead us to detect medium/large effects (OR = 2.8).

Complete case analysis used - only participants who were retained until 6 month follow-up.

Number of Participants Who Have Obtained Breast Cancer Screening

Analyses were conducted using GEE with an exchangeable correlation structure and a gamma distribution with log link. All models included study arm, time, and the study arm\*time. Covariates included age, education, and mammography history. With 150 Latinas, alpha = 0.05, power = 0.80, ICC = 0.0-0.05, we expected to detect small/medium interaction effects.

Knowledge

Cultural Beliefs

Self-Efficacy

Social Norms

Supportive Network size

This is a complete case analysis for outcome data, with all available data being used for participants who completed the 6-month follow-up.

Changes in Psychosocial Facilitators of Screening Survey Measures

We used ordinal regression, given the non-normal distribution revealed by preliminary analyses. Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size. Power analyses suggested that with 150 Latinas, alpha = .05, power = .80, we would be able to detect a small effect (Cohen's f = 0.05).

Complete case analysis used, wherein we focus on participants who completed the 6-month follow-up surveys.

Number of Individuals to Whom Participants Exchanged Information About Breast Cancer Screening.

Overall Study

Same questionnaire for all three arms except validated question "Stage of decision making" followed by question about participation in screening or not when invited at age 50.

This is not an intervention but a survey study with three different versions of the questionnaire.

Same questionnaire for all three arms except text and question presenting breast cancer screening as a choice (between screening and alternative of no screening) followed by question about participation in screening or not when invited at age 50.

This is not an intervention but a survey study with three different versions of the questionnaire.

Same questionnaire for all three arms except text and question presenting breast cancer screening as an opportunity (no presentation of alternative) followed by question about participation in screening or not when invited at age 50.

This is not an intervention but a survey study with three different versions of the questionnaire.

Investigating preferences and attitudes towards breast cancer screening information, invitation, and decision making as well as barriers for breast cancer decision making. This will be done by using different framing of information (choice framing vs. opportunity framing), question about stage of decision making, and general questions about screening information and invitation.

Stage of Decision Making

Choice framing

Opportunity Framing

The aim is to investigate potential barriers to informed decision making in a breast cancer screening context. This is a necessary step prior to developing and investigating improved information or decision aids in a Danish breast cancer screening context.

In this study, preferences and attitudes towards breast cancer screening, invitation, and decision making among Danish women will be investigated. The aim is to gain knowledge about barriers for (informed) decision making in a Danish breast cancer screening context. The study will be conducted by sending out an online questionnaire to women aged 44-49 in Denmark. The questionnaire will be sent out using the official digital mail system, e-Boks, with an invitation, link, and login information to access the online questionnaire. The questionnaire will consist of background questions about the participants, questions related to the current information material and invitation to the Danish breast cancer screening program, and questions about decision making and informed choice. Women will be randomized to one of three questionnaires: 1) Questionnaire with "Stage of Decision Making" to investigate women's decision making process regarding participation in screening, 2) Questionnaire with choice framing (presentation of a choice between participation in breast cancer screening or no screening), or 3) Questionnaire with opportunity framing (only presentation of screening, no alternative) to investigate decision making process and impact of different framing. The main hypothesis for this study is that 80% of Danish women have already made their decision about screening participation when presented to the opportunity framing and 70% when presented to the choice framing.

1000 women will be invited to each group in this study and thus 3000 in total, as this is the minimum number satisfying the requirements for both the main hypothesis and secondary aims (not described in detail here). No similar studies were found, therefore, this sample size calculation is based on proportions of 50% to have enough power in our study. With a desired standard error no larger than 2.5%, 400 women are required (SE of a binomial random variable). Assuming 40% participation, a study population of 1000 women in each group is required.

Next, questionnaire data will be linked to register data on sociodemographic factors from Statistics Denmark.

The study is registered at Aarhus University's internal records: 2016-051-000001, 2563.

Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context

The main hypothesis for this study is that 80% of Danish women have already made their decision about screening participation when presented to the opportunity framing and 70% when presented to the choice framing. Further, a question about being more or less willing to participate after reading screening information will also provide information for this hypothesis.

This will be investigated by comparing the choice vs. opportunity framing, with questions about reading health information in general and about having read the information about breast cancer screening in this questionnaire. In addition, this will be investigated with questions about being more or less positive/negative about screening and more or less willing to participate after reading the screening information.

This will be investigated using two statements about seeing the participation as an individual choice or as a recommendation from health authorities to comply with.

This will be investigated with different statements about preferences regarding who should make the screening decision (the individual women or health authorities).

University of Aarhus

Subjects enrolled in this group will receive a full field digital mammogram, digital breast tomosynthesis exam and an automated whole breast ultrasound exam as part of their visit.

Digital Breast Tomosynthesis

Automated Whole Breast Ultrasound

Full Field Digital Mammography

This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis

Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts

Abnormal interpretation rates for each modality (FFDM and DBT+V-Preview, with and without ABUS+V-Preview).

Sensitivity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS

Specificity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS

Cancer Rate will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS

Positive Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS

Negative Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS

GE Healthcare

Conventional mammography screening (standard of care)

Screen exam will be analysed with an AI system (Transpara, ScreenPoint, Nijmegen, The Netherlands) that assigns exams with a cancer-risk score from 1 to 10, as well as presenting CAD-marks at suspicious findings. Exams with risk score 1-9 will be single read and exam with score 10 will be double read. Risk scores and CAD-marks are provided to the reader(s). The reader(s) will decide whether to recall the woman for work-up or not (as per standard of care). In addition, exams with the highest 1% risk will by default be recalled with the exception of obvious false positives.

AI screening modality

Screen exams will be read by two radiologists without the support of AI.

Conventional screening modality

Kristina Lång, MD PhD

The purpose of this randomized controlled trial is to assess whether AI can improve the efficacy of mammography screening, by adapting single and double reading based on AI derived cancer-risk scores and to use AI as a decision support in the screen reading, compared with conventional mammography screening (double reading without AI).

European guidelines recommend that mammography exams in breast cancer screening are read by two breast radiologists to ensure a high sensitivity. Double reading is, however, resource demanding and still results in missed cancers. Computer-aided detection based on AI has been shown to have similar accuracy as an average breast radiologist. AI can be used as decision support by highlighting suspicious findings in the image as well as a means to triage screen exams according to risk of malignancy.

Eligible women will be randomized (1:1) to the intervention (AI-integrated mammography screening) or control arm (conventional mammography screening). In the intervention arm, exams will be analysed with AI and triaged into two groups based on risk of malignancy. Low risk exams will be single read and high risk exams will be double read. The high risk group will contain appx. 10% of the screening population. Within the high-risk group, exams with the highest 1% risk will by default be recalled by the readers with the exception of obvious false positives. AI risk scores and Computer-Aided Detection (CAD)-marks of suspicious calcifications and masses are provided to the reader(s). In the control arm, screen exams are double read without AI (standard of care). Considering the interplay of number of interval cancers and workload, the study will be considered successful if the interval-cancer rate in the intervention arm is not more than 20% larger than in the control arm. If the interval-cancer rate is statistically and clinically significantly lower in the intervention arm than in the control arm, AI-integrated mammography screening will be considered superior to conventional mammography screening.

Participants have the possibility to opt-out. If they do not opt-out, neither the participant nor the nurse performing the screen exam will know to what study arm the participant was allocated. The radiologist reading the screen exam will however not be blinded to allocation information.

Mammography Screening With Artificial Intelligence (MASAI)

A Randomized, Single-blinded, Controlled Trial on the Efficacy of Mammography Screening With Artificial Intelligence - the MASAI Study

IPD could be considered to be shared in future collaborations.

Women with interval cancer per 1000 screens

Women with screen-detected cancer per 1000 screens

Women with false positive per 1000 screens

Screen detection of cancer in relation to cancer type, size and stage

Characterization of interval cancers per type, size and stage

Number of screen-readings and number of consensus meetings

The incremental cost-effectiveness ratio for AI-integrated mammography screening versus standard of care

Unilabs

Cancer Registry of Norway

Region Skane

Women without breast implants participating in the mammography screening program.

Women with breast implants participating in the mammography screening program.

Breast screening mammograms use X-rays to look for cancers that are too small to see or feel.

Mammography screening

Emma Hansson, MD,PhD

Emma Hansson, PhD

The purpose of the study is to survey how many women have breast implants in the mammography screening population and the effect of implants on the number and type of examinations and on costs.

Biological women included in the mammography screening program.

Effect of Breast Implants om Mammography Screening

Health economic analysis of the effects of implants on mammography screening

Prevalence of breast implants in a mammography screening population.

Survey of if breast implants infer extra examinations (mammography, ultrasounds, biopsies, diagnostic operations) in connection with screening mammography.

Vastra Gotaland Region

This group will receive their standard of care mammogram only. Participants in this arm will not receive the FAST MRI.

Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram.

Patients in this group will receive Breast MRI and annual mammography. Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram. The intervention is the addition of the FAST Breast MRI.

Patients in this group will receive Breast MRI and annual mammography. Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram.

FAST MRI and mammography screening

Jean Seely, MD FRCPC

Breast Magnetic Resonance Imaging (MRI) has been shown to be the most accurate test for detecting breast cancer however, MRI is not always reliable because it can indicate the presence of cancer when in reality, there is none; this is called a 'false positive' result. A history of breast carcinoma alone does not qualify a patient for ongoing monitoring with breast MRI. This study is being done to assess a new technique called FAST breast MRI. A FAST breast MRI is different than a traditional breast MRI because it has much fewer sequences and takes approximately 3 minutes for the scan. MRI sequences are combinations of magnetic pulses that collect information about the tissues. There is no radiation associated with an MRI.

The purpose of this study is to determine the impact on patient health when a FAST breast MRI is used as a screening technique in women with a personal history of cancer. It has been shown that FAST breast MRI is similar to routine breast MRI in the detection of breast cancer, but it has not been proven that FAST breast MRI will help women who have a personal history for breast cancer. Currently, routine breast MRI is not part of the standard of care in screening for breast cancer in women who have a prior personal history of breast cancer. By evaluating FAST MRI the investigators are able to study the effects of this short MRI on cancer detection in women with a personal history of breast cancer, and on the impact on overall health. The investigators estimate that 300 participants will be enrolled in the study from The Ottawa Hospital Cancer Centre at The Ottawa Hospital, General Campus and the Women's Breast Health Centre at The Ottawa Hospital, Civic Campus. All of the participants have had a history of breast carcinoma.

Given the demand for breast MRI screening by breast cancer survivors and oncologists, we plan to perform a randomized controlled trial in a select patient population of breast cancer survivors who would not normally be eligible for breast MRI screening. This study will determine whether using FAST MRI in addition to mammography will reduce anxiety in patients compared to the current standard of care: mammography alone. If it turns out to reduce anxiety, the next step would be to conduct a large-scale multi-centre randomized control trial (RCT) to evaluate whether FAST MRI is more sensitive and whether the increased sensitivity leads to improved clinical outcomes.

The purpose of our study is to determine the impact on patient anxiety of FAST Breast MRI as a surveillance technique in women with a personal history of breast cancer.

FAST MRI Study in Breast Cancer Survivors

Planning on submitting preliminary results to RSNA 2017 and full publication by Oct 2018.

Ottawa Hospital Research Institute

Dr. Jean Seely

Decision aid

Heather Davey, B.Psych, MPH

Nehmat Houssami, MBBS, PhD

Erin Mathieu, B.Ed, MPH

Andrew Page, BA (Hons)

Richard Taylor, MBBS, PhD

Sian Smith, BSc (Hons)

Phyllis Butow, MPH, PhD

The purpose of the study is to develop and evaluate a decision aid to assist women aged 70 years and over to make an informed choice about whether to continue screening mammography.

The primary aims of the study are to assess the impact of the decision aid on (1) the proportion of women who make an informed choice about whether to continue screening mammography, and (2) the participation rates of screening among women aged 70 years and older.

There are two secondary aims of the study. First, to measure the effect of the decision support tool on women's decisional conflict, anxiety, and knowledge about the issues involved in screening mammography. Second, to compare relationships between a woman's objective and perceived risk of breast cancer with her decision to continue or stop screening mammography.

Screening mammography is recommended for women aged 50-69 years but there is no recommendation for women aged 70 years and older. Therefore the decision to continue or stop having screening mammograms are largely dependent on the importance women place on the perceived benefits and harms of screening.

The decision aid is a paper workbook and worksheet containing information on the outcomes of screening mammography for women aged 70 years and older (based on a published model- Barratt et al. 2005), steps to decision making and values clarification exercise. Currently it is not known if a decision aid with information about the benefits and risks of screening mammography can help women aged 70 years and older to make an informed choice. In addition to delivering benefits to individual women in assisting them to to make an informed choice the decision aid may lead to benefits for service providers such as improved efficiency and cost-effectiveness of screening women in this age group. Thus the impact of a decision aid in the efficiency and cost-effectiveness of screening mammography is an important but untested hypothesis.

Australian Screening Mammography Decision Aid Trial (ASMDAT)

An Evaluation of a Decision Aid for Women Aged Over 70 Considering Whether to Stop or Continue Having Mammography Screening.

University of Sydney

Symptoms and General Pathology

Body Weight

Weight Loss

Body Weight Changes

12 week program with additional follow up at 24 weeks.

Waitlist control. No intervention for first 12 weeks. Participants given the option to participate in the program after 24 weeks.

1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision.

CONECT

Maria D Thomson, PhD

The objective of this protocol is to adapt and pilot test an existing lifestyle modification intervention for weight loss for women with overweight or obesity who have had a recent false positive mammography screen. The purpose of this pilot trial is to establish feasibility of Connect Online to Engage Change Tool (CONECT) to promote weight loss through increased physical activity and diet change.

Addressing Modifiable Breast Cancer Risk Factors With Project CONECT

Addressing Modifiable Breast Cancer Risk Factors With Project CONECT [Connect Online to Engage Change Tool]

waist circumference measured at 12 and 24 weeks.

for intervention group only, percent weight loss at 24 weeks

recruitment of 30 participants with 70% retention at 12 weeks

Completion of 80% of intention components including wearing Fitbit tracker, completed of the weekly weightings, answering emails, attending intervention sessions

participants will be asked to use the Fitbit Heart Rate (HR) Physical Activity Monitor to track daily steps and minutes of physical activity.

assessed by 7 day Physical Activity Recall Scale (PAR)

assessed by Automated Self-Administered (ASA) 24

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Empowering Latinas to Obtain Breast Cancer Screenings	NCT02964234	Breastcancer Breast Diseases	Empowerment Education	52 Years - 75 Years	University of Illinois at Chicago
Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context	NCT05444725	Breast Cancer F... Mammography Scr... Decision Making Information See...	Stage of Decisi... Choice framing Opportunity Fra...	44 Years - 49 Years	University of Aarhus
Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts	NCT02042456	Breast Cancer	Digital Breast ... Automated Whole... Full Field Digi...	18 Years -	GE Healthcare
Mammography Screening With Artificial Intelligence (MASAI)	NCT04838756	Breast Cancer	AI screening mo... Conventional sc...	40 Years - 74 Years	Region Skane
Effect of Breast Implants om Mammography Screening	NCT05222100	Breast Cancer	Mammography scr...	40 Years - 75 Years	Vastra Gotaland Region
FAST MRI Study in Breast Cancer Survivors	NCT02244593	Breast Cancer	FAST MRI and ma...	18 Years -	Ottawa Hospital Research Institute
Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context	NCT05444725	Breast Cancer F... Mammography Scr... Decision Making Information See...	Stage of Decisi... Choice framing Opportunity Fra...	44 Years - 49 Years	University of Aarhus
Australian Screening Mammography Decision Aid Trial (ASMDAT)	NCT00247442	Breast Neoplasm...	Decision aid	70 Years -	University of Sydney
Australian Screening Mammography Decision Aid Trial (ASMDAT)	NCT00247442	Breast Neoplasm...	Decision aid	70 Years -	University of Sydney
Addressing Modifiable Breast Cancer Risk Factors With Project CONECT	NCT02871388	Weight Loss Breast Cancer R...	CONECT	40 Years - 65 Years	Virginia Commonwealth University
Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context	NCT05444725	Breast Cancer F... Mammography Scr... Decision Making Information See...	Stage of Decisi... Choice framing Opportunity Fra...	44 Years - 49 Years	University of Aarhus
Empowering Latinas to Obtain Breast Cancer Screenings	NCT02964234	Breastcancer Breast Diseases	Empowerment Education	52 Years - 75 Years	University of Illinois at Chicago

Spots Global Cancer Trial Database for mammography screening