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Decision Support for BRCA Testing in Ethnically Diverse Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03470402
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Columbia University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer BRCA1 Mutation BRCA2 Mutation Ovarian Cancer Other: RealRisks Other: BNAV Other: iNYP Other: Standard Educational Material Other: High-Risk Message Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A cluster randomization in which both a provider and his/her enrolled patients will be enrolled in either the intervention or control arm.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Decision Support for BRCA Testing in Ethnically Diverse Women
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Experimental: Intervention group

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.

Other: RealRisks
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.
Other Name: RealRisks Decision Aid

Other: BNAV
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.
Other Names:
  • Breast Cancer Risk Navigation Tool
  • BNAV Toolbox

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

Other: Standard Educational Material
Enrolled patient participants will be sent standard educational brochures on genes and breast cancer and the CUMC breast cancer prevention clinic
Other Name: Standard Educational Brochures

Other: High-Risk Message
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).
Other Name: High Risk Letter

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

Other: Standard Educational Material
Enrolled patient participants will be sent standard educational brochures on genes and breast cancer and the CUMC breast cancer prevention clinic
Other Name: Standard Educational Brochures

Other: High-Risk Message
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).
Other Name: High Risk Letter




Primary Outcome Measures :
  1. Uptake rate of genetic counseling by 6 months [ Time Frame: Up to 6 months ]
    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)


Secondary Outcome Measures :
  1. Change in patient decision conflict scale score [ Time Frame: Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months ]

    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.


  2. Shared Decision Making (Likert Scale Score) [ Time Frame: Post Clinic Encounter (Approximately 6 Weeks) ]

    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).


  3. Patient Informed Choice Score [ Time Frame: 6 Months ]
    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).


Other Outcome Measures:
  1. Change in Risk Perceptions (Likert Scale Score) [ Time Frame: Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months ]

    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.


  2. Change in Breast Cancer Worry (Likert Scale Score) [ Time Frame: Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months ]
    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.

  3. Change in Breast Cancer Knowledge scale score [ Time Frame: Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months ]
    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.

  4. Change in Attitudes (Likert Scale Score) [ Time Frame: Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months ]
    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.

  5. Change in Decision Self Efficacy (Likert Scale Score) [ Time Frame: Baseline, Post Intervention/Control (1 Month), 6 Months ]
    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.

  6. Change in Decision Regret (Likert Scale Score) [ Time Frame: Post Clinic Encounter (Approximately 6 Weeks), 6 months ]

    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.


  7. Change in Confidence in Managing Patients with a Family History of Breast/Ovarian Cancer (Likert Scale Score) [ Time Frame: Baseline, 6 Months ]

    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.


  8. Change in Provider Knowledge questionnaire score [ Time Frame: Baseline, 6 Months ]

    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.


  9. Change in Provider Attitudes [ Time Frame: Baseline, 6 Months ]

    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.


  10. Change in Orientation Towards Shared Decision Making (Likert Scale Score) [ Time Frame: Baseline, 6 Months ]

    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.


  11. Change in Subjective Norms [ Time Frame: Baseline, 6 Months ]

    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.


  12. Change in Perceived behavioral control [ Time Frame: Baseline, 6 Months ]

    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.


  13. Change in behavior Intention test score [ Time Frame: Baseline, 6 Months ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (Patient Participants):

  • Women, age 21-75 years
  • Meets criteria for genetic testing based on family history
  • Sees a primary care provider in the Columbia University (CUMC) /New York Presbyterian (NYP) Ambulatory Care Network
  • Understands as is willing to provide informed consent in English or in Spanish

Exclusion Criteria (Patient Participants):

  • Prior genetic counseling or testing for hereditary breast and ovarian cancer (HBOC)
  • A personal history of breast or ovarian cancer

Inclusion Criteria (Health Care Provider Participants):

  • Primary care providers, such as attending physicians, residents, nurse practitioners, physician assistants, and midwives, who see patients at CUMC/NYP Ambulatory Care Network clinics
  • Able to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470402


Contacts
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Contact: Thomas B Silverman, MPH 2123050356 tbs2129@cumc.columbia.edu
Contact: Awilda Marte 2128514921 aa3227@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Thomas B Silverman, MPH    212-305-0356    tbs2129@cumc.columbia.edu   
Contact: Awilda Marte    212-851-4921    aa3227@cumc.columbia.edu   
Principal Investigator: Rita Kukafka, DrPH, MA         
Sub-Investigator: Katherine D. Crew, MD, MS         
Sponsors and Collaborators
Columbia University
American Cancer Society, Inc.
Investigators
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Principal Investigator: Rita Kukafka, DrPH, MA Columbia University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT03470402    
Other Study ID Numbers: AAAR3676
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Columbia University:
Breast Cancer Prevention
Genetic Testing
Genetic Counseling
Personalized Prevention
Precision Prevention
Precision Medicine
Risk Assessment
Decision Making
Decision Aid