Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)

• ClinicalTrials.gov Identifier: NCT04496739
• Recruitment Status: Recruiting
• First Posted: August 3, 2020
• Last Update Posted: March 22, 2021
• Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Southwest Oncology Group

Tracking Information

• First Submitted Date: July 29, 2020
• First Posted Date: August 3, 2020
• Last Update Posted Date: March 22, 2021
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: June 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2020)

Chemoprevention informed choice [ Time Frame: At 6 months ]

Will be provided by chemoprevention knowledge scale, a 1-item attitudes scale, and chemoprevention decision and measure at 6 and 12 months on the S1904 Follow-Up Choice form. All enrolled patients who provide outcomes data at the 6-month timepoint will be included in the primary analysis under the intention-to-treat principle. The primary analysis of the intervention effect on informed choice at 6 months will be based on a logistic regression model using a generalized estimating equation approach to account for clustering. Additional supportive analyses will adjust for both patient and clinic level factors. If there are substantial missing data for the components of the primary endpoint, a sensitivity analysis will be conducted imputing a response of no informed decision making for those women with missing information.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 25, 2020)

• Perceived breast cancer risk [ Time Frame: Up to 12 months ]
  Will be assessed by absolute estimate ("How do you rate your chance of developing breast cancer?"), comparative risk ("Overall, how do you think your chance of developing breast cancer compares to the average woman your age?"), and numeric risk ("Please place an X on the line below at the point showing what you think your chance is of developing breast cancer in the next five years"). All are assessed on a scale of 0% to 100%, with 0% as "no chance of breast cancer" and 100% as "definitely will get breast cancer."
• Actual breast cancer risk score [ Time Frame: Up to 12 months ]
  A numeric score between the values of 0% and 100%, as determined by the Breast Cancer Surveillance Consortium (BCSC) risk models. The 5-year and 10-year risk estimates are used. The items needed for the BCSC risk models are obtained at baseline from the S1904 Onstudy.
• Accuracy of risk perception [ Time Frame: Up to 12 months ]
  Will be defined as the difference between numeric perceived breast cancer 10-year risk estimate (subjective) and actual 10-year breast cancer risk score, according to the BCSC risk model (objective). 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.
• Breast cancer worry [ Time Frame: Up to 12 months ]
  Will be measured by two Likert-style items, with responses ranging from "Not at all" (1) to "All of the time" (7). Items are reported and scored separately. Breast cancer worry is assessed on the S1904 Breast Cancer Risk Questionnaire.
• Decision conflict [ Time Frame: Up to 12 months ]
  Will be assessed on the S1904 Breast Cancer Risk Questionnaire. Will be measured by a validated 10-item scale with 3 response categories (Yes/Unsure/No) to assess the level of conflict women feel about their decisions regarding chemoprevention. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict) and will be scored according to the User Manual - Decisional Conflict Scale.
• Decision regret [ Time Frame: Up to 12 months ]
  Will be assessed on the S1904 Decision Questionnaire. Will be measured by a validated 5-item scale composed of 5-point Likert-style items. Scores that range from 0 (no regret) to 100 (high regret). It is scored according to the User Manual - Decision Regret Scale.
• Chemoprevention usage [ Time Frame: Up to 5 years ]
  Will be assessed on the S1904 Follow-Up form and the S1904 Breast Cancer Risk-Reducing Pill Usage form. Among patients who do not have a diagnosis of invasive breast cancer or ductal carcinoma in situ, it will be defined as reporting having started taking or currently taking a selective estrogen receptor modulators (SERM) or aromatase inhibitor (AI) for primary prevention, as assessed by self-report, and taking at least one dose of a SERM or AI for primary prevention, as assessed by the site based on the electronic health record log. Both measures will be reported. Reasons for never starting chemoprevention will be recorded.
• Chemoprevention adherence [ Time Frame: Up to 5 years ]
  Will be assessed using a 3-item scale for patients currently taking a SERM or AI. Responses are given values 1 through 5, with the response corresponding to perfect adherence assigned 1. The three scores are averaged if at least 2 of the 3 items have responses. Non-adherence is defined as an average score of greater than 1. Will be assessed on the S1904 Breast Cancer Risk-Reducing Pill Usage form.
• Reasons for chemoprevention discontinuation [ Time Frame: Up to 5 years ]
  For patients who report discontinuing a SERM or AI, reasons for discontinuing chemoprevention are reported on the S1904 Breast Cancer Risk-Reducing Pill Usage form.
• Shared decision-making [ Time Frame: Up to 6 months ]
  Will be assessed by a validated 9-item scale with Likert-style responses to assess shared decision-making about chemoprevention. Scores range from 0 to 100. Provider and patient measures are evaluated separately and scored according to their respective validation papers. Will be assessed on the S1904 Patient Shared Decision-Making Questionnaire and on the S1904 Provider Shared Decision-Making Questionnaire.

Original Secondary Outcome Measures (submitted: July 29, 2020)

• Perceived breast cancer risk [ Time Frame: Up to 10 years ]
  Will be assessed by absolute estimate, comparative risk, and numeric risk on the S1904 Breast Cancer Risk Questionnaire.
• Actual breast cancer risk score [ Time Frame: Up to 10 years ]
  A numeric score between the values of 0% and 100%, as determined by the Breast Cancer Surveillance Consortium (BCSC) risk models. The 5-year and 10-year risk estimates are used. The items needed for the BCSC risk models are obtained at baseline from the S1904 Onstudy.
• Accuracy of risk perception [ Time Frame: Up to 10 years ]
  Will be defined as the difference between numeric perceived breast cancer 10-year risk estimate (subjective) and actual 10-year breast cancer risk score, according to the BCSC risk model (objective). 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.
• Breast cancer worry [ Time Frame: Up to 12 months ]
  Will be measured by two Likert-style items, with responses ranging from "Not at all" (1) to "All of the time" (7). Items are reported and scored separately. Breast cancer worry is assessed on the S1904 Breast Cancer Risk Questionnaire.
• Decision conflict [ Time Frame: Up to 12 months ]
  Will be assessed on the S1904 Breast Cancer Risk Questionnaire. Will be measured by a validated 10-item scale with 3 response categories (Yes/Unsure/No) to assess the level of conflict women feel about their decisions regarding chemoprevention. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict) and will be scored according to the User Manual - Decisional Conflict Scale.
• Decision regret [ Time Frame: Up to 12 months ]
  Will be assessed on the S1904 Decision Questionnaire. Will be measured by a validated 5-item scale composed of 5-point Likert-style items. Scores that range from 0 (no regret) to 100 (high regret). It is scored according to the User Manual - Decision Regret Scale.
• Chemoprevention usage [ Time Frame: Up to 5 years ]
  Will be assessed on the S1904 Follow-Up form and the S1904 Breast Cancer Risk-Reducing Pill Usage form. Among patients who do not have a diagnosis of invasive breast cancer or ductal carcinoma in situ, it will be defined as reporting having started taking or currently taking a selective estrogen receptor modulators (SERM) or aromatase inhibitor (AI) for primary prevention, as assessed by self-report, and taking at least one dose of a SERM or AI for primary prevention, as assessed by the site based on the electronic health record log. Both measures will be reported. Reasons for never starting chemoprevention will be recorded.
• Chemoprevention adherence [ Time Frame: Up to 5 years ]
  Will be assessed using a 3-item scale for patients currently taking a SERM or AI. Responses are given values 1 through 5, with the response corresponding to perfect adherence assigned 1. The three scores are averaged if at least 2 of the 3 items have responses. Non-adherence is defined as an average score of greater than 1. Will be assessed on the S1904 Breast Cancer Risk-Reducing Pill Usage form.
• Reasons for chemoprevention discontinuation [ Time Frame: Up to 5 years ]
  For patients who report discontinuing a SERM or AI, reasons for discontinuing chemoprevention are reported on the S1904 Breast Cancer Risk-Reducing Pill Usage form.
• Shared decision-making [ Time Frame: Up to 6 months ]
  Will be assessed by a validated 9-item scale with Likert-style responses to assess shared decision-making about chemoprevention. Scores range from 0 to 100. Provider and patient measures are evaluated separately and scored according to their respective validation papers. Will be assessed on the S1904 Patient Shared Decision-Making Questionnaire and on the S1904 Provider Shared Decision-Making Questionnaire.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)
• Official Title: Cluster Randomized Controlled Trial of Patient and Provider Decision Support to Increase Chemoprevention Informed Choice Among Women With Atypical Hyperplasia or Lobular Carcinoma In Situ - Making Informed Choices on Incorporating Chemoprevention Into Care (MiChoice)
• Brief Summary: This trial studies the implementation of decision support tools integrated into the electronic health record and patient portal for patients with atypical hyperplasia or lobular carcinoma in situ and healthcare providers. Decision support tools are designed to improve informed choice about breast cancer chemoprevention. Recognizing barriers and facilitators that can influence the adoption of decision support tools at recruitment centers may help researchers learn how to best implement them into clinical practice.

Detailed Description

PRIMARY OBJECTIVE:

I. To compare the frequency of chemoprevention informed choice at 6 months after registration among women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) between the intervention (RealRisks decision aid/breast cancer risk navigation [BNAV] + standard educational materials) and control (standard educational materials alone) arms.

SECONDARY OBJECTIVES:

I. To assess patient chemoprevention knowledge, chemoprevention intention/decision, perceived breast cancer risk and worry, accuracy of breast cancer risk perception, decision conflict and decision regret at baseline, 6 months, and 12 months in the intervention and control arms.

II. To compare patient chemoprevention usage, adherence, and reasons for discontinuation of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) annually for up to 5 years between the intervention and control arms.

III. To assess shared decision-making about chemoprevention among patients and healthcare providers after their 6-month clinic visit in the intervention and control arms.

IMPLEMENTATION OBJECTIVE:

I. To assess the implementation of the decision support tools, RealRisks and BNAV, into clinic workflow, and to better understand barriers and facilitators to chemoprevention usage by conducting telephone/video-conference interviews of healthcare providers and high-risk women with AH or LCIS assigned to the active intervention.

OUTLINE: Recruitment centers are randomized to 1 of 2 groups.

GROUP I (CONTROL): Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website.

GROUP II (INTERVENTION): Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website. Patients receive patient-centered decision support within the patient portal via an action plan summarizing their breast cancer risk profile, their risks and benefits of SERMs and AIs, and personal preferences for chemoprevention. Health care providers receive decision support and action plans based on their patients' interactions with RealRisks via the BNAV provider-centered support tool within the electronic health record (EHR). A sample of patients participate in an audio-recorded interview via telephone or video conference over 45-60 minutes at 12 months after registration. A sample of health care providers participate in 3 audio-recorded interviews via telephone or video conference over 45-60 minutes each at baseline, within 12-36 months after study activation, and within 12 months after study closure to accrual.

After completion of study, patients are followed up at 6, 12, 24, 36, 48, and 60 months.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Atypical Hyperplasia of the Breast
• Lobular Breast Carcinoma In Situ
• Pleomorphic Lobular Breast Carcinoma In Situ

Intervention

• Behavioral: Cancer Educational Materials
  Receive educational materials about breast cancer risk and chemoprevention via RealRisk
• Other: Decision Aid
  Given patient-centered decision support via an action plan
• Other: Decision Aid
  Given decision support and action plans based on patient's interactions with RealRisks via the BNAV support tool
• Other: Interview
  Participate in audio-recorded interview via telephone or video conference
• Other: Questionnaire Administration
  Ancillary studies

Study Arms

• Active Comparator: Group I (educational materials)
  Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website.
  Interventions:

  • Behavioral: Cancer Educational Materials
  • Other: Questionnaire Administration
• Experimental: Group II (educational materials, decision support, interview)
  Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website. Patients receive patient-centered decision support within the patient portal via an action plan summarizing their breast cancer risk profile, their risks and benefits of SERMs and AIs, and personal preferences for chemoprevention. Health care providers receive decision support and action plans based on their patients' interactions with RealRisks via the BNAV provider-centered support tool within the EHR. A sample of patients participate in an audio-recorded interview via telephone or video conference over 45-60 minutes at 12 months after registration. A sample of health care providers participate in 3 audio-recorded interviews via telephone or video conference over 45-60 minutes each at baseline, within 12-36 months after study activation, and within 12 months after study closure to accrual.
  Interventions:

  • Behavioral: Cancer Educational Materials
  • Other: Decision Aid
  • Other: Decision Aid
  • Other: Interview
  • Other: Questionnaire Administration

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 29, 2020): 415
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2024
• Estimated Primary Completion Date: June 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients must have histologically-confirmed atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) documented by breast pathology report at any time in the past. Patients with borderline breast lesions and pleomorphic LCIS are also eligible
• Patients must be women at least 35 and no more than 74 years of age at registration, since the Breast Cancer Surveillance Consortium (BCSC) risk calculator is valid only for this age range
• Both pre/perimenopausal and postmenopausal women are eligible
• Patients must be able to read and write in English or Spanish since study questionnaires and educational materials are only available in English and Spanish
• Baseline questionnaires must be completed prior to patient registration
• The S1904 Patient Contact form must be completed prior to patient registration
• Patients must be able to access the internet and receive email or text messages. This is required to access study materials and receive email/text message reminders from the S1904 Study Team at Columbia University Irving Medical Center (CUIMC). The patient decision aid, RealRisks, is accessible via smartphones, tablets, or personal computers. If patients do not own these devices, local study personnel will provide resources for patients to access RealRisks via computer kiosks or tablets in clinic waiting rooms or public locations, such as community centers or public libraries
• Patients and healthcare providers must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
• IMPLEMENTATION: Providers who enrolled in S1904 at Group 2 (intervention) recruitment center and consented to future contact are eligible to participate in the interviews
• IMPLEMENTATION EVALUATION: Patients who registered to S1904 at a Group 2 (Intervention) Recruitment Center and consented to be contacted for future research are eligible to participate in the interviews
• Recruitment Centers must be National Clinical Trials Network (NCTN), National Cancer Institute Community Oncology Research Program (NCORP) or Minority Underserved (MU)-NCORP institutions
• Recruitment Centers must have an active EHR and patient portal used in the outpatient clinics which is common and accessible across all sites belonging to the Recruitment Center
• Recruitment Centers must be willing to allow the S1904 study team access to the site's application program interface (API) for integration of the study materials (standard educational materials and decision support tools) into the EHR and patient portal. (NOTE: Both Group 1 (control) and Group 2 (intervention) recruitment centers may access the standard educational materials via the patient portal or uniform resource locator (URL)/website)
• Recruitment centers must see at least 50 AH and/or LCIS patients per year
• Recruitment centers must identify a lead principal investigator (PI) to facilitate recruitment and retention of patients and healthcare providers and to participate in quarterly stakeholder meetings/conference calls
• Recruitment centers must be willing to register at about 16 patients and 8 healthcare providers to the study
• Recruitment Centers must be willing to submit monthly screening logs to CUIMC
• Providers must regularly see patients with AH or LCIS at an approved recruitment center
• Providers must be willing to provide informed consent and complete an online baseline questionnaire
• Providers who will register patients must be registered members of a Cooperative Group
• Providers who register patients to S1904 must be willing to see those same patients for their 6-month study visits, as the provider intervention tools require that the "treating investigator" as designated in OPEN and the provider at the 6-month study visit be the same

Exclusion Criteria:

• Patients must not have a history of invasive breast cancer or ductal carcinoma in situ

• Patients must not have prior or current use of selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs)

  • NOTE: The following are approved SERMS and AIs, however, the study is not limited to these.

    • SERMs: tamoxifen, raloxifene
    • AIs: anastrozole, exemestane, letrozole
• Patients must not be currently taking hormone replacement therapy
• Patients must not have a history of bilateral mastectomies or breast implants since the risk calculator is not applicable to these women
• Patients must not be pregnant or lactating
• Premenopausal patients must not have a history of thromboembolism, since it is a contraindication to tamoxifen. Tamoxifen is the only Food and Drug Administration (FDA)-approved drug for breast cancer chemoprevention among high-risk premenopausal women, whereas postmenopausal women are eligible for both SERMs and AIs

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04496739
• Other Study ID Numbers: S1904; NCI-2019-08755 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); S1904 ( Other Identifier: SWOG ); SWOG-S1904 ( Other Identifier: DCP ); S1904 ( Other Identifier: CTEP ); R01CA226060 ( U.S. NIH Grant/Contract ); UG1CA189974 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Southwest Oncology Group
• Study Sponsor: Southwest Oncology Group
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Katherine D Crew; Southwest Oncology Group

• PRS Account: Southwest Oncology Group
• Verification Date: January 2021