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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
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This trial will test a decision support web based intervention for women at increased risk for breast cancer due to breast density and other risk factors (age, race/ethnicity, family history of breast cancer, history of prior breast biopsies), and to consider MRI and/or chemoprevention to manage their breast cancer risk.
Along with better-known risk factors such as family history having dense breasts is one of the strongest breast cancer risk factors. Extremely dense breast tissue affects about 10% of women, with an additional third having heterogeneously dense breasts. Women in these categories have 3-6 times the risk of breast cancer as compared to women with least density. Although breast density is measured on routine screening mammograms, it is not typically communicated to patients. This is changing as a result of legal mandates and approaches need to be tested to effectively integrate this clinical information in care. Therefore,we have developed an intervention to support decision making about cancer risk management (MRI and chemoprevention) for women at clinically elevated risk using a web-based intervention that will evaluate the efficacy of a web based intervention with personalized risk information communication versus usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized Web Intervention Arm | Experimental | Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors. |
|
| Usual Care Arm | Active Comparator | Women will be assigned to view a website that will take them to the American Cancer Society website to view general risk information for breast cancer related to breast density. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care Arm | Behavioral | Health information provided by the American Cancer Society Website |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Taking Chemoprevention at 12 Months | Number of Participants who initiated chemoprevention is measured as receipt of any prescription for tamoxifen or raloxifene, based on health plan pharmacy data at any time from consent through 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Distress Related to Cancer Risk | Distress was measured with the item, "Please choose the number (from 0-10) that best describes how much distress you have been experiencing related to your cancer risk in the past week including today, from 0 (no distress) to 10 (extreme distress)." | 6 weeks and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne C O'Neill, PhD | Georgetown University/Lombardi Comprehensive Cancer Center | Principal Investigator |
| Karen Wernli, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 28124 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28257920 | Background | Knerr S, Wernli KJ, Leppig K, Ehrlich K, Graham AL, Farrell D, Evans C, Luta G, Schwartz MD, O'Neill SC. A web-based personalized risk communication and decision-making tool for women with dense breasts: Design and methods of a randomized controlled trial within an integrated health care system. Contemp Clin Trials. 2017 May;56:25-33. doi: 10.1016/j.cct.2017.02.009. Epub 2017 Feb 28. | |
| 31977078 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Personalized Web Intervention Arm | Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors. |
| FG001 | Usual Care Arm | Women will be assigned to view a website that will take them to the American Cancer Society website to view general risk information for breast cancer related to breast density. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Personalized Web Intervention Arm | Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors. |
| BG001 | Usual Care Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Taking Chemoprevention at 12 Months | Number of Participants who initiated chemoprevention is measured as receipt of any prescription for tamoxifen or raloxifene, based on health plan pharmacy data at any time from consent through 12 months. | Posted | Count of Participants | Participants | 12 months |
|
Participants could report any and all issues to the study team, from enrollment and consent through the 12 month survey.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Personalized Web Intervention Arm | Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne O'Neill, PhD | Georgetown University | 202-687-0869 | sco4@georgetown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2023 | Mar 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Personalized Web Intervention Arm | Behavioral | Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors. |
|
| Number of Participants Receiving Breast MRI |
Number of participants receiving breast MRI was assessed using EHR data on receipt of breast imaging within network or claims data from outside imaging facilities. |
| 12 months |
| Result |
| Mahorter SS, Knerr S, Bowles EJA, Wernli KJ, Gao H, Schwartz MD, O'Neill SC. Prior breast density awareness, knowledge, and communication in a health system-embedded behavioral intervention trial. Cancer. 2020 Apr 15;126(8):1614-1621. doi: 10.1002/cncr.32711. Epub 2020 Jan 24. |
| 33482952 | Result | Wernli KJ, Bowles EA, Knerr S, Leppig KA, Ehrlich K, Gao H, Schwartz MD, O'Neill SC. Characteristics Associated with Participation in ENGAGED 2 - A Web-based Breast Cancer Risk Communication and Decision Support Trial. Perm J. 2020 Dec;24:1-4. doi: 10.7812/TPP/19.205. |
| 33554037 | Result | Wernli KJ, Knerr S, Li T, Leppig K, Ehrlich K, Farrell D, Gao H, Bowles EJA, Graham AL, Luta G, Jayasekera J, Mandelblatt JS, Schwartz MD, O'Neill SC. Effect of Personalized Breast Cancer Risk Tool on Chemoprevention and Breast Imaging: ENGAGED-2 Trial. JNCI Cancer Spectr. 2021 Jan 14;5(1):pkaa114. doi: 10.1093/jncics/pkaa114. eCollection 2021 Feb. |
| 34582721 | Result | Bowles EJA, O'Neill SC, Li T, Knerr S, Mandelblatt JS, Schwartz MD, Jayasekera J, Leppig K, Ehrlich K, Farrell D, Gao H, Graham AL, Luta G, Wernli KJ. Effect of a Randomized Trial of a Web-Based Intervention on Patient-Provider Communication About Breast Density. J Womens Health (Larchmt). 2021 Nov;30(11):1529-1537. doi: 10.1089/jwh.2021.0053. Epub 2021 Sep 28. |
| 34813048 | Result | Conley CC, Wernli KJ, Knerr S, Li T, Leppig K, Ehrlich K, Farrell D, Gao H, Bowles EJA, Graham AL, Luta G, Jayasekera J, Mandelblatt JS, Schwartz MD, O'Neill SC. Using Protection Motivation Theory to Predict Intentions for Breast Cancer Risk Management: Intervention Mechanisms from a Randomized Controlled Trial. J Cancer Educ. 2023 Feb;38(1):292-300. doi: 10.1007/s13187-021-02114-y. Epub 2021 Nov 23. |
| 35723793 | Derived | Wernli KJ, Smith RE, Henderson LM, Zhao W, Durham DD, Schifferdecker K, Kaplan C, Buist DSM, Kerlikowske K, Miglioretti DL, Onega T, Alsheik NH, Sprague BL, Jackson-Nefertiti G, Budesky J, Johnson D, Tosteson ANA. Decision quality and regret with treatment decisions in women with breast cancer: Pre-operative breast MRI and breast density. Breast Cancer Res Treat. 2022 Aug;194(3):607-616. doi: 10.1007/s10549-022-06648-7. Epub 2022 Jun 20. |
Women will be assigned to view a website that will take them to the American Cancer Society website to view general risk information for breast cancer related to breast density.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Distress related to cancer risk | Distress was measured with the item, "Please choose the number (from 0-10) that best describes how much distress you have been experiencing related to your cancer risk in the past week including today, from 0 (no distress) to 10 (extreme distress). | Mean | Standard Deviation | Distress thermometer (0-10) |
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|
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| Secondary | Distress Related to Cancer Risk | Distress was measured with the item, "Please choose the number (from 0-10) that best describes how much distress you have been experiencing related to your cancer risk in the past week including today, from 0 (no distress) to 10 (extreme distress)." | Posted | Mean | Standard Deviation | score on a scale | 6 weeks and 12 months |
|
|
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| Secondary | Number of Participants Receiving Breast MRI | Number of participants receiving breast MRI was assessed using EHR data on receipt of breast imaging within network or claims data from outside imaging facilities. | Posted | Count of Participants | Participants | 12 months |
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| 0 |
| 492 |
| 0 |
| 492 |
| 0 |
| 492 |
| EG001 | Usual Care Arm | Women will be assigned to view a website that will take them to the American Cancer Society website to view general risk information for breast cancer related to breast density. | 0 | 503 | 0 | 503 | 0 | 503 |
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| D017437 |
| Skin and Connective Tissue Diseases |