Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Lothar Lilge, PhD

The proposed pilot study is part of the design and development process of a final questionnaire that aims to gain insight on factors that influences acceptance and adoption of breast cancer risk assessment in women. Feedback on the questionnaire will help identify potential issues of clarity, comprehensibility, and reliability; and to identify possible biases that often accompany a designed questionnaire. Information gained from the large-scale study will provide directions for the development of educational strategies in the TIBS research program that could accompany increases in public awareness of risk factors, the availability of risk assessment tools and preventive lifestyle.

The development of risk assessment tools for preventive oncology aims to identify all members of a given at risk subpopulation to whom intervention strategies can be offered to reduce their risk. An ideal risk assessment tool should permit assessment of a woman's breast cancer risk in order to a) identify the needs for and potential benefits of risk reducing interventions; b) direct her to the most appropriate risk reducing interventions, and; c) monitor the efficacy of the intervention in actually reducing risk. Earlier implemented risk reduction interventions could potentially preclude needs for more drastic lifestyle and less desirable changes, such as chemoprevention and prophylactic surgeries, later in life. Currently, no such classification and monitoring technique has proven effective. Yet several candidate techniques are being investigated. While risk assessment tools may potentially provide future benefits, the effectiveness of current and new risk assessment tool developments certainly requires users to perceive these tools as potentially effective. It is this perception of potential effectiveness that would motivate them to adhere to risk assessment protocols the evaluation of which would help provide the evidence base for understanding true effectiveness. The investigators of this study are currently developing a Transillumination Breast Spectroscopy (TIBS) research program, consisting of ongoing studies of different types. As part of the technology assessment process for TIBS, and in part due to the further development of the research program, there is a need to address factors that may directly or indirectly influence willingness to participate in a breast cancer risk assessment. The primary goal of this pilot study is to determine the content validity of the investigator-designed draft questionnaire. The outcome measure of a final questionnaire is to assess general acceptability of breast cancer risk assessment and degree of acceptability based on a) knowledge and awareness of breast cancer, b) varying levels of involvement and invasiveness of a risk assessment procedure, and c) perceived potential effectiveness of risk reducing interventions. Acceptability of risk assessment, willingness to undergo therapy and follow through with recommendations is assessed independent of currently available and new developments of risk assessment procedures.The secondary goal of this study is to test the overall comprehensibility (e.g. language, clarity), question acceptability (e.g. appropriateness of response selection), and reliability of the questionnaire.Information gained from this pilot study will be considered in the development of a final questionnaire to be administered to a large population representative cohort. The results of the planned future study will provide directions for the development of educational strategies in the TIBS research program that should accompany increases in public awareness on risk factors, the availability of risk assessment tools and preventive lifestyle and insight into the extent of broad-based community education strategies required to initiate and sustain interest in assessment for breast cancer risk among women in the general public to facilitate informed decision-making related to breast health in these women. Critical gaps in knowledge of risk factors and preventive lifestyle changes identified in this subsequent study can provide a focus for the educational strategies, which may address: the costs of risk assessment (e.g. stress, financial, inconvenience) and the development of understandable and practical educational materials to ensure their accessibility to a broad range of audiences, including those women who may be candidates for risk reducing interventions but who are not yet aware of its availability. The ultimate hypothesis of a future large-scale study is:General knowledge and awareness of breast cancer, psychosocial factors such as perceived risk susceptibility and perceived costs of risk assessment (e.g. stress, financial, inconvenience), perceived effectiveness of intervention strategies, and socio-demographic position are determinants of accepting risk assessment.However, to help guide questionnaire design and development, a pilot study is required to identify issues of the questionnaire such as content validity, overall comprehensibility (e.g. language, clarity), question acceptability (e.g. appropriateness of response selection), and reliability. To achieve the goals of the pilot study, we intend to recruit 50 women between ages of 25 - 74 years (10 per age group, 25 - 34, 35 - 44, 45 - 54, 55 - 65, 65 - 74). A 26-item investigator-designed, self-administered questionnaire was designed with standard measures. The questionnaire consists of 7 sections covering the following topics: Breast Cancer Knowledge and Awareness, Susceptibility Perception, Likelihood of Undergoing Risk Assessment, Benefits and Barriers of Risk Assessment, Breast Cancer Risk Assessment, Risk Reduction Intervention, and Demographics

Psychosocial Study on Breast Cancer Risk Assessment

A Pilot Study: Psychosocial and Socio-Demographic Determinants of Accepting Breast Cancer Risk Assessment

University Health Network, Toronto

Symptoms and General Pathology

Virilism

Persons assigned female or intersex at birth who identify as TGD and are considering gender-affirming chest masculinization surgery.

Gail and IBIS Tools will be utilized to calculate mean lifetime breast cancer risk

Breast Cancer Risk Assessment

Chandler S Cortina

The population of transgender and gender-diverse (TGD) persons in Wisconsin and the U.S. is steadily increasing. As this population grows, the number of individuals seeking gender-affirming therapies, including gender-affirming operations and gender-affirming hormone therapy, is also growing. An example of gender-affirming surgery is chest masculinization surgery, in which most breast tissue is removed in a person assigned female or intersex at birth to allow the chest to appear masculine. Gender-affirming chest masculinization surgery is not generally considered equivalent to an oncologic mastectomy, which aims to removal all breast tissue for future breast cancer reduction or current breast cancer treatment.

The goals of this investigation are to 1) determine the percent of TGD persons considering chest masculinization surgery who have an elevated lifetime risk of breast cancer development and/or a pathogenic genetic mutation; 2) measure the percent who are at risk and choose to undergo risk-reducing mastectomies as part of chest masculinization surgery; and 3) assess and compare self-perceived breast cancer risk with calculated risk.

The results of this study will substantially inform TGD patients and surgeons on the utility of personalized breast cancer risk assessment prior to chest masculinization surgery and the accuracy of self-perceived breast cancer risk in TGD persons.

Persons who identify as transgender, nonbinary, and/or gender-diverse (TGD) who were assigned female and/or intersex at birth.

BC Risk Assessment Before Top Surgery

Assessing Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Persons

Validated breast cancer risk calculators (IBIS and Gail) will be used to determine lifetime breast cancer risk of participants enrolled into the study. Ranges and 95% CI will be made to estimate the percent of TGD persons at risk.

To determine whether those TGD persons at elevated risk of breast cancer development choose to undergo risk-reducing mastectomies as part of their chest masculinization surgery.

A visual analog scale from 0-100% will be used to compare and assess the self-perceived estimated breast cancer risk with calculated breast cancer risk. 13% is marked as the average cisgender women's risk of breast cancer and participants report their self-perceived risk as single whole integer (ex. 8%, 15%, 25%, etc.) on the scale from 0-100% where 0-12% represents below average risk person and 13-100% represent above average risk.

Medical College of Wisconsin

Assistant Professor of Surgery

Carcinoma

Hyperplasia

Carcinoma in Situ

Carcinoma, Lobular

Participants will self-administer FHIR-enhanced RealRisks with access to risk communication games, family history pedigree and modules on chemoprevention and genetics testing, if relevant to them based on their risk and family history. The investigators are interested in gaining short-term feedback on patient activation and other patient reported outcomes, which will be assessed before and within 2 weeks after using RealRisks.

RealRisks is a web-based patient-centered decision aid (DA) designed to improve: 1) accuracy of breast cancer risk perceptions; 2) chemoprevention knowledge, and 3) informed choice. The DA includes audio and modules about breast cancer risk (including interactive games on risk communication) and chemoprevention. Through RealRisks, the investigators will collect information on breast cancer risk factors to calculate a patient's BCSC breast cancer risk score and also factors that influenced decision-making about chemoprevention through the preference elicitation game. RealRisks generates an action plan for patients summarizing their personalized breast cancer risk profile and preference elicitation for chemoprevention. Of note, the tool is designed for patients with varying levels of health literacy and numeracy and is available in English and Spanish.

RealRisks

Rita Kukafka, DrPH, MA

Katherine Crew, MD, MS

Electronic health records (EHRs) are an increasingly common source for populating risk models, but whether used to populate validated risk assessment models or to de-facto build risk prediction models, EHR data presents several challenges. The purpose of this study is to assess how the integration of patient generated health data (PGHD) and EHR data can generate more accurate risk prediction models, advance personalized cancer prevention, improve digital access to health data in an equitable manner, and advance policy goals for Patient Generated Health Data (PGHD) and EHR interoperability.

While breast cancer (BC) mortality has declined, this decline has begun to plateau, particularly among racial/ethnic minorities. Women identified as high-risk for BC may benefit from chemoprevention, testing for BC susceptibility genes, screening, and other personalized risk reducing strategies; however, barriers exist including the time required to conduct risk assessment of each woman in a population. Electronic health records (EHRs), a common source for populating risk assessment models present challenges, including missing data, and data type more accurate when provided by patients compared to EHRs. The investigators previously extracted EHR data on age, race/ethnicity, family history of BC, benign breast disease, and breast density to calculate BC risk according to the Breast Cancer Surveillance Consortium (BCSC) model among 9,514 women. Comparing self-reported and EHR data, more women with a first-degree family history of BC (14.6% vs. 4.4%) and benign breast biopsies (21.3% vs. 11.3%) were identified with patient reported data, but EHR data identified more women with atypia or lobular carcinoma in situ (1.1% vs. 2.3%). The EHR had missing data on race/ethnicity for 26.8% of women and on first-degree family history of BC for 87.2%. Opportunely, Fast Healthcare Interoperability Resources (FHIR), application programming interfaces (APIs), and new legislation offer an elegant solution for automated BC risk assessment that integrates both patient-generated health data and EHR data to harness the strengths of each approach. In prior work, the investigators developed the RealRisks decision aid using an iterative design process to equitably maximize acceptability, and usability. RealRisks promotes understanding of BC risk and collects patient-entered data to calculate BC risk according to the Gail model, BCSC, and BRCAPRO. When FHIR became available, the investigators updated RealRisks to automatically populate information for BC risk calculation from the EHR, and designed a prototype interface that shows this data to patients with a request to review and modify data before running the risk assessments. The investigators recently conducted a feasibility study to demonstrate that EHR data from FHIR could be incorporated into automated BC risk calculation. To increase the likelihood of developing disseminatable and equitable strategies that integrate EHR and PGHD data for risk assessment and personalized BC risk-reduction, the focus is to refine and test our approach among diverse multiethnic women. The aims are: 1) conduct user evaluations to refine FHIR-enhanced RealRisks; 2) assess the effect of the FHIR-enhanced RealRisks on patient activation, risk perception, and usability in a pilot study of multiethnic high-risk women; and 3) identify multilevel barriers to implementing FHIR-enhanced RealRisks into clinical care. Given the mortality associated with BC, focused efforts are needed to provide accurate risk assessment and shared decision-making about risk-reducing strategies, especially in minority women who are more likely to be diagnosed with advanced stage BC. If successful, the approach tested in this application may provide a roadmap for broadly improving digital access to health data and reducing BC mortality in an equitable manner.

The investigators will conduct a pre-/post- feasibility study of 55 high-risk diverse multiethnic women with follow-up to assess accuracy of breast cancer risk perception (perceived lifetime risk minus actual risk according to the Gail model) and patient activation.

RealRisks is a patient-facing, web-based decision support tool that was developed using multiple design sessions, participatory workshops, and usability studies to arrive at guiding principles that focus on 1) personalized breast cancer risk calculation, 2) interactive games to communicate breast cancer risk, and 3) patient preferences elicitation to elicit values supporting breast cancer options. The FHIR enhanced-RealRisks functionality that this research focuses on will allow RealRisks to utilize a patient's electronic health record data to support accurate risk assessment.

FHIR-Enhanced RealRisks to Improve Accuracy of Breast Cancer Risk Assessments

Integrating EHR and Patient-generated Health Data for Breast Cancer Risk Assessment and Decision Support in a Diverse Multiethnic Population

Measured via the Perceived Health Web Site Usability Questionnaire (PHWSUQ), three separate sections to evaluate patient satisfaction (e.g., "It is easy to find specific information"), ease of use (e.g., "It was easy to understand how to get to EHR data"), and usefulness (e.g., "Using the FHIR-enhanced RealRisks will help me improve my understanding about my BC risk; what I can do to reduce my risk"). The PHWSUQ consists of 12 items on a 7-point Likert scale ranging from Very Unsatisfied (1) to Very Satisfied (7). Scores range from 12-84, with a higher scores indicating greater overall usability of the tool.

Validated 13-item Patient Activation Measure, which measures patient knowledge, skill, and confidence in self-management of health. Scores range from 0 to 100; higher scores indicate greater activation.

Difference between perceived numeric risk estimate and actual lifetime breast cancer risk score, according to the Gail or BCSC risk models, categorized as accurate if the difference between subjective and objective risk estimates are 10% in either direction, underestimate if \>10% below objective risk, and overestimate if \>10% above objective risk.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Psychosocial Study on Breast Cancer Risk Assessment	NCT00234715	Breast Cancer		25 Years - 74 Years	University Health Network, Toronto
BC Risk Assessment Before Top Surgery	NCT06239766	Breast Cancer Risk Reduction	Breast Cancer R...	18 Years -	Medical College of Wisconsin
FHIR-Enhanced RealRisks to Improve Accuracy of Breast Cancer Risk Assessments	NCT05810025	Breast Cancer	RealRisks	35 Years - 74 Years	Columbia University

Spots Global Cancer Trial Database for breast cancer risk assessment