Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Women who screen as eligible for BRCA genetic counseling will receive the education and decision support tool, RealRisks, along with standard educational material and a high-risk message. The high-risk status of the women will also be flagged in the online tool used by the hospital to visualize electronic health record data (iNYP).

The enrolled health care providers of these women will be given access to BNAV, which summarizes their enrolled patients' breast cancer risk profiles and provides educational resources on genetic testing and prevention options. Before their clinical encounter with an enrolled patient, these providers will also be sent the personalized breast cancer risk summary that is created by data the patient entered into RealRisks.

Women who screen as eligible for BRCA genetic counseling will receive standard educational material and a high-risk message. The high-risk status of the women will also be flagged in the online tool used by the hospital to visualize electronic health record data (iNYP).

RealRisks is a web-based patient decision aid with modules on risk assessment, family history and breast cancer, genetic testing, and prevention options. Participants enter family history data into RealRisks, and RealRisks calculates 5-year breast cancer risk, lifetime breast cancer risk, and the probability of carrying a BRCA mutation. This information is then interactively presented to the participant. RealRisks facilitates the participant in identifying their intention to undergo BRCA genetic testing and the factors that are important to the participant in making this decision. RealRisks produces a summary of all of this information that the participant can print and take with her to a health care appointment.

RealRisks

BNAV is a web-based decision support tool for healthcare providers with educational modules on genetic testing, chemoprevention, patient-centered care, and screening. BNAV also provides providers with a table outlining their enrolled patients' breast cancer risk, eligibility for genetic testing, and stated preferences.

BNAV

Enrolled patients will have their eligibility for BRCA genetic testing flagged in iNYP, the hospital's portal for visualizing EHR data (standard practice).

iNYP

Enrolled patient participants will be sent standard educational brochures on genes and breast cancer and the CUMC breast cancer prevention clinic

Standard Educational Material

Enrolled patient participants will receive a letter that informs them that they meet eligibility criteria for BRCA genetic testing, outlines prevention options, and recommends discussing genetic counseling referral with their health care provider (standard practice).

High-Risk Message

Rita Kukafka, DrPH, MA

The objective of this study is to expand genetic testing for hereditary breast and ovarian cancer syndrome to a broader population of high-risk women by prompting appropriate referrals from the primary care setting with the use of an electronic health record-embedded breast cancer risk navigation (BNAV) tool. To address patient-related barriers to genetic testing, the investigators developed a web-based decision aid, RealRisks, which is designed to improve genetic testing knowledge, accuracy of breast cancer risk perceptions, and self-efficacy to engage in a collaborative dialogue about genetic testing.

The study design is a randomized controlled trial of patient educational materials and provider electronic health record (EHR) notice alone (control arm) or in combination with RealRisks and BNAV (intervention arm). The investigators hypothesize that combining the patient-centered RealRisks with the provider-centered BNAV will increase appropriate uptake of genetic counseling. The investigators also hypothesize that genetic counseling decisions will be more informed, and result in less decision conflict and improved shared decision making.

Hereditary breast and ovarian cancer syndrome (HBOC) is an inherited condition that is most commonly associated with mutations in the BRCA1 and BRCA2 genes. Mutation carriers have lifetime risks of breast and ovarian cancer of 60-80% and 20-40%, respectively. Risk management options include intensive breast cancer screening, risk-reducing surgeries, and chemoprevention, which have been shown to improve early detection and reduce cancer incidence and mortality. In particular, prophylactic bilateral salpingo-oophorectomy has been associated with a 60-77%reduction in all-cause mortality among BRCA mutation carriers. Based upon U.S. Preventive Services Task Force guidelines, an estimated 5%-10% of women unaffected with breast cancer are eligible for genetic testing for HBOC, but only 14% of those eligible were referred and 4% had BRCA genetic testing. Many women may be unaware of their high-risk status due to our inability to adequately screen them in the primary care setting. Other reasons for low uptake include inadequate time for counseling and insufficient knowledge about risk-reducing strategies. Women from racial/ethnic minorities are less likely to seek genetic testing for HBOC, contributing to poorer clinical outcomes in these populations compared to non-Hispanic whites. Alternatively, decreasing inappropriate genetics referrals is also important for reducing anxiety and allowing genetic services to be used more efficiently. More research is needed to develop optimal strategies for engaging high-risk women in informed decision-making about genetic testing for HBOC.

The objective of this study is to expand genetic testing for hereditary breast and ovarian cancer syndrome to a broader population of high-risk women by prompting appropriate referrals from the primary care setting with the use of an electronic health record-embedded breast cancer risk navigation (BNAV) tool. To address patient-related barriers to genetic testing, the investigators developed a web-based decision aid, RealRisks, which is designed to improve genetic testing knowledge, accuracy of breast cancer risk perceptions, and self-efficacy to engage in a collaborative dialogue about genetic testing.

The study design is a randomized controlled trial of patient educational materials and provider EHR notice alone (control arm) or in combination with RealRisks and BNAV (intervention arm). The investigators hypothesize that combining the patient-centered RealRisks with the provider-centered BNAV will increase appropriate uptake of genetic counseling. The investigators also hypothesize that genetic counseling decisions will be more informed, and result in less decision conflict and improved shared decision making.

A cluster randomization in which both a provider and his/her enrolled patients will be enrolled in either the intervention or control arm.

Decision Support for BRCA Testing in Ethnically Diverse Women

Change in the accuracy of risk perception among patient participants. Perception will be assessed by comparing a patients perceived risk with their actual risk, and to compare between intervention and control group will be assessed at baseline, after receiving intervention or control materials, after the clinic encounter, and at 6 months. Perceived risk will be measured by Likert and numerical scales and actual risk will be determined by a model.

Likert Scale: Eight 6-point items measuring perceived ability to perform mathematical tasks and preferences for receiving word-based or number-based information.

Analysis: Question 7 reverse coded, then find mean of all 8 item scores. Score 1 = least accurate risk perception, Score 6= most accurate risk perception. A higher score indicates a better outcome.

Likert Scale measuring breast cancer worry among patient participants. To compare between intervention and control group at baseline, after receiving intervention or control materials, after the clinic encounter, and at 6 months Two 7-point items measuring how often patient worries about developing cancer and how much this worry interferes with everyday life. 1="none of the time"; 4="Some of the time"; 7="All of the time". Scores summed.Higher score indicates more worry and more interference with everyday life. Lower score indicates a better outcome.

True false scale measuring knowledge of breast cancer and HBOC among patient participants. To compare between intervention and control group at baseline, after receiving intervention or control materials, after the clinic encounter, and at 6 months 11 true/false items Analysis: Sum # correct; 50%-100% correct is considered good knowledge and indicates better outcome, 0-49% correct is considered poor knowledge.

Likert scale measuring patient attitudes towards BRCA genetic testing. To compare between intervention and control group at baseline, after receiving intervention or control materials, after the clinic encounter, and at 6 months Four 7-point Likert scale items, which are summed; 22 as cut-point for positive/negative items. 22 and above considered positive attitudes. A positive attitude is indicative of a better outcome. 21 and below considered negative attitudes. Up to one missing item will be imputed using the average of the remaining three item scores.

Likert scale measuring degree of self efficacy in making a genetic testing decision among patient participants. To compare between intervention and control group at baseline, after receiving intervention or control materials, after the clinic encounter, and at 6 months 11 5-point Likert scale items (0=not at all confident - 4=very confident) Analysis: items are summed, divided by 11, and multiplied by 25. Scores range from 0 (extremely low efficacy) to 100 (extremely high efficacy). A higher score indicates a better outcome.

Likert scale measuring measuring the extent to which a patient regrets the decision to undergo or not undergo genetic counseling. To compare between intervention and control groups after the clinic encounter and at 6 months Low-literacy option: five 5-point Likert scale items (1=Strongly Agree - 5=Strongly Disagree) measuring whether regret was felt to be present, whether the decision was the right one, whether the patient would make the same decision again, whether the decision was a wise one, and whether the decision had resulted in harm.

Analysis: Reverse code Regret_2 and Regret_4. Subtract 1 from each item score and multiply by 25. Mean scores of items Regret_1-Regret_5; A score of 0 means no regret, while a score of 100 means high regret. A lower score indicates a better outcome.

Likert scale measuring confidence in managing patients with a family history of breast/ovarian cancer among health care provider participants. To compare between intervention and control group at baseline and six months Three questions ascertaining respondents' perceived level of confidence in their knowledge of medical statistics, ability to effectively communicate medical statistics to patients and/or families, and ability to help patients and/or families understand information about probabilities or risks.

6-point Likert scale: "Not at all" to "Extremely" confident. Analysis: mean scores, 0= "Not at all" confident - 5= "Extremely" Confident. A higher score indicates a better outcome.

Three "Agree/Disagree" statement and two multiple choice questions measuring BRCA genetic testing knowledge among health care provider participants. To compare between intervention and control group at baseline and 6 months.

Analysis: Number of multiple choice items answered correctly ( 0, 1, or 2 items answered correctly). Score range from 0-2. The higher the score, the greater the provider knowledge. A higher score indicates a better outcome.

Likert scale measuring attitudes held by health care provider participants regarding BRCA genetic testing. To compare between intervention and control group at baseline and 6 months.

One statement, 7 point Likert scale: 0="strongly disagree" - 6= "strongly agree" Analysis: High scores indicate stronger intention, perception of stronger social pressure, and perception of greater control. A higher score indicates a better outcome.

Likert scale measuring the extent to which a respondent believes that patients desire information and should be part of decision making process. Among health care provider participants. To compare between intervention and control group at baseline and 6 months.

9-item scale measuring the extent to which a respondent believes that patients desire information and should be part of the decision making process.

6-point Likert Scale: 0= "Strongly Disagree" - 5= "Strongly Agree" Analysis: Total score, score ranging from 0-45, lower score= patient centered, higher score= doctor-centered. The greater the change in orientation towards shared decision making, the better the outcome.

Likert scale measuring extent to which providers believe others would expect them to refer patients to BRCA genetic testing. For health care provider participants. To compare between intervention and control group at baseline and 6 months.

7 point item: 0= "Strongly disagree" - 6= "Strongly agree" Analysis: High scores indicate perception of stronger social pressure and indicates a better outcome.

Likert scale measuring extent to which providers believe they are able to refer patients to BRCA genetic testing. For provider participants. To compare between intervention and control group at baseline and 6 months.

7 point item: 0= "very difficult" - 6 = "very easy" Analysis: High scores indicate perception of greater control. A higher score indicates a better outcome.

Multiple choice measuring a providers intention to refer a patient to BRCA genetic testing. For health care provider participants. To compare between intervention and control group at baseline and 6 months.

7 point item: e.g. 0= very difficult - 6= very easy Analysis: High scores indicate stronger intention and better outcome.

The primary endpoint is to determine the uptake of genetic counseling for HBOC syndrome by 6 months in the intervention arm (RealRisks Decision Aid and BNAV toolbox) compared to the control arm (Standard educational materials)

The decisional conflict scale (DCS) measures personal perceptions of: uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.

It includes 10 yes/no items (0=yes, 2=unsure, 4=no). Analysis: Item scores are summed, divided by 10, and multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). A lower score indicates a better outcome.

The Shared Decision Making (SDM) questionnaire collects information on the process in which clinicians and patients work together to make decisions and select tests, treatments and care plans based on clinical evidence that balances risks and expected outcomes with patient preferences and values. It consists of 9 items with each item scored on a 6-point Likert scale (0=completely disagree to 5=Complete Agree) from the SDM-Q-9.

Analysis: A raw total score between 0 and 45 calculated by summing the scores of all items. If required, imputation of up to two missing items using the mean of the items that made up the raw score. For the standardization of the raw score, a linear transformation into a scale ranging from 0 to 100 (multiplication of the raw score by 20/9), with zero indicating the lowest level of perceived SDM and 100 indicating the highest level of perceived SDM (better outcome).

The degree to which a decision is based on relevant, good quality information, and reflects the decision-maker's values. To compare between the intervention and control group at 6 months. To be an informed choice, a patient needs a good knowledge score and a decision that is consistent with their attitude score. Analysis: Informed Choice= Good knowledge (score 50% and above) AND Positive Attitude (score 22 and above) AND positive decision ("I decided to get genetic testing" or "I was already tested"), OR Good knowledge AND Negative attitude (score 21 and below) AND negative decision ("I decided not to get genetic testing") Uninformed Choice: Poor knowledge, OR Good knowledge, but uptake inconsistent with attitudes Analysis: Uninformed Choice= Good knowledge (score 50% and above) AND Negative attitude AND positive decision OR Good knowledge AND Negative Attitude Score AND positive decision, OR Poor knowledge (49% and below).

American Cancer Society, Inc.

Columbia University

Breast Diseases

Skin Diseases

Women at high risk for developing breast cancer will use a decision support tool, RealRisks, that facilitates discussion of breast cancer risk with their providers who will have access to the BNAV provider clinical decision support tool.

Women at high risk for developing breast cancer will receive standard breast health education brochures.

RealRisks is a web-based patient decision aid with modules that present information about risk assessment and chemoprevention.

Breast Cancer Risk Navigation (BNAV) tool is a web-based decision support tool with modules that present pertinent information for primary care providers regarding breast cancer risk assessment and preventative measures for their patients.

Katherine D Crew, MD, MS

The purpose of this randomized controlled trial (RCT) is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer prevention options. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. The investigators hypothesize that improving accuracy of breast cancer risk perception and understanding of the risks and benefits of breast cancer risk lowering drugs, also known as chemoprevention, will increase the uptake of chemoprevention in the primary care setting.

Breast cancer is the most common malignancy among women in the U.S. and the primary prevention of this disease is a major public health issue. The U.S. Preventive Services Task Force and other professional organizations recommend that clinicians discuss chemoprevention with high-risk women. Breast cancer chemoprevention with anti-estrogens, such as tamoxifen, raloxifene, exemestane, and anastrozole, is under-utilized, despite several randomized controlled trials demonstrating a 40-65% decrease in breast cancer incidence among high-risk women. Compounding this underutilization is the fact that a large proportion of women may be unaware of their high-risk status due to the investigators' inability to adequately screen them in the primary care setting. Further research is needed to determine how knowledge about breast cancer, actual/perceived risk, and risks/benefits of chemoprevention are best communicated to women in order to promote breast cancer prevention strategies.

The investigators hypothesize that combining a patient-centered decision aid with a physician-centered decision support tool integrated into clinic workflow will improve accuracy of breast cancer risk perception, facilitate referrals for specialized risk counseling, and increase chemoprevention uptake. We anticipate that the BNAV tool will facilitate referrals to the breast clinic by primary care providers (PCPs) and that the RealRisks decision aid will prime high-risk women to seek these referrals. The primary endpoint is uptake of a selective estrogen receptor modulator (SERM) or Aromatase inhibitor (AI) for breast cancer chemoprevention at 6 months (after the next primary care appointment) in the active arm compared to usual care.

Study of Web-based Decision Aids for Increasing Breast Cancer Chemoprevention in the Primary Care Setting

Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Randomized Controlled Trial

To measure the patient's accuracy of perceived breast cancer risk before and after exposure to the RealRisks decision aid compared to those patients in the control group receiving usual care. Perception will be assessed by comparing the difference between a patient's perceived risk and their actual risk based on the Gail breast cancer model. Patients are asked to make a comparative risk assessment about themselves on a 3-point Likert scale.

To assess patient's breast cancer knowledge before and after exposure to the RealRisks decision aid compared to those patients in the control arm by comparing the difference between a patient's responses to a 13-item scale assessing knowledge with response options of true, false, or unsure.

The primary endpoint is to determine the uptake rate of a SERM or AI medication for breast cancer chemoprevention at 6 months (after the next primary care visit) in the active arm compared to usual care (control arm). Electronic health records will be used to track chemoprevention uptake after exposure to the intervention, the RealRisks decision aid, or the control, standard standard breast health education brochures.

Behavioral intention for chemoprevention will be assessed one month after baseline among those in the active arm compared to patients receiving usual care (control arm).

To study appropriate referral rate to the breast clinic by primary care providers of high-risk patients in the active arm compared to patients receiving usual care (control arm).

To study appointment completion rate at the breast clinic by high-risk patients in the active arm compared to patients receiving usual care (control arm).

National Cancer Institute (NCI)

Associate Professor of Medicine and Epidemiology

50 women at high-risk for developing breast cancer will use a decision support tool, RealRisks, when discussing breast cancer risk with their providers who will have access to the BNAV provider clinical decision support tool.

Katherine D Crew, M.D., M.S.

The purpose of this pilot study is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer chemoprevention. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. The investigator hypothesizes that improving accuracy of breast cancer risk perception and understanding of the risks/benefits of chemoprevention will enhance informed decision-making and uptake of breast cancer prevention strategies in the primary care setting.

Breast cancer is the most common malignancy among women in the U.S. and the primary prevention of this disease is a major public health issue. The U.S. Preventive Services Task Force and other professional organizations recommend that clinicians discuss chemoprevention with high-risk women. Breast cancer chemoprevention with anti-estrogens, such as tamoxifen, raloxifene, exemestane, and anastrozole, is under-utilized, despite several randomized controlled trials demonstrating a 40-65% decrease in breast cancer incidence among high-risk women. Compounding this underutilization is the fact that a large proportion of women may be unaware of their high-risk status due to the investigators inability to adequately screen them in the primary care setting. Further research is needed to determine how knowledge about breast cancer, actual/perceived risk, and risks/benefits of chemoprevention are best communicated to women in order to promote breast cancer prevention strategies.

This study assesses risk communication and shared decision-making in patient-clinician dyads by administering validated measures at baseline, after interacting with the tools prior to the clinic visit, and after the clinical visit (quantitative analysis); and by using observer-based methods of audio-tape recordings of their clinical encounters (qualitative analysis).

The investigator hypothesizes that combining a patient-centered decision aid with a physician-centered decision support tool integrated into clinic workflow will improve accuracy of breast cancer risk perception, facilitate referrals for specialized risk counseling, and increase chemoprevention uptake.

Know Your Risk: Assessment at Screening for Breast Cancer - Pilot Study

Study of Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Pilot

To measure the patient's accuracy of perceived breast cancer risk before and after exposure to the RealRisks decision aid. Perception will be assessed by comparing the difference between a patient's perceived risk and their actual risk based on the Gail breast cancer model. Patients are asked to make a comparative risk assessment about themselves on a 3-point Likert scale.

To assess patient's breast cancer knowledge before and after exposure to the RealRisks decision aid by comparing the difference between a patient's responses to a 13-item scale assessing knowledge with response options of true, false, or unsure.

To determine the uptake rate in the breast clinic after offering specialized risk counseling to a broader population of racially/ethnically diverse women screened in the primary care setting. Electronic health records will be used to track chemoprevention uptake after exposure to the RealRisks decision aid.

To study appropriate referral rate by primary care providers of high-risk patients to the breast clinic.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Decision Support for BRCA Testing in Ethnically Diverse Women	NCT03470402	Breast Cancer BRCA1 Mutation BRCA2 Mutation Ovarian Cancer	RealRisks BNAV iNYP Standard Educat... High-Risk Messa...	21 Years - 75 Years	Columbia University
Study of Web-based Decision Aids for Increasing Breast Cancer Chemoprevention in the Primary Care Setting	NCT03069742	Breast Neoplasm	RealRisks BNAV	35 Years - 75 Years	Columbia University
Know Your Risk: Assessment at Screening for Breast Cancer - Pilot Study	NCT02954900	Breast Neoplasm...	RealRisks BNAV	35 Years - 75 Years	Columbia University

Spots Global Cancer Trial Database for bnav

Every month we try and update this database with for bnav cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bnav

Every month we try and update this database with for bnav cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bnav cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.