Summary

This trial studies the effectiveness of two interventions on patient reported outcomes of patient centered communication and decision making about breast cancer treatment. The first intervention consists of enhancements to an existing patient-facing breast cancer treatment decision tool called iCanDecide, that supports the management of worry, distress, and anxiety as compared to an existing tool. The second intervention consists of a clinician dashboard that populates information after patients view either website regarding any ongoing issues or concerns.

Objectives

PRIMARY OBJECTIVES:
I. To demonstrate that the enhanced iCanDecide (iCanDecide-emotional support enhancement [ESE]) intervention is more effective than the standard version (iCanDecide-standard [S]) resulting in higher patient knowledge about locoregional treatment risks and benefits.
II. To demonstrate that the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient knowledge about locoregional treatment risks and benefits.

SECONDARY OBJECTIVES:
I. To demonstrate that the enhanced iCanDecide (iCanDecide-ESE) intervention is more effective than the standard version (iCanDecide-S), resulting in higher patient-reported breast cancer self-efficacy and lower patient reported cancer worry.
II. To demonstrate that the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient-reported breast cancer self-efficacy.
III. To evaluate whether the enhanced iCanDecide (iCanDecide-ESE) intervention is more effective than the standard version (iCanDecide-S), resulting in better appraisal of global patient centered communication related to locoregional treatment, specifically: higher scores on patient-clinician communication (surgeon), subjective decision quality for locoregional treatment, patient centered communication and values concordant treatment.
IV. To evaluate whether the activation of the Clinician Dashboard (CDB) is more effective than not using a CDB, resulting in better appraisal of global patient centered communication, specifically, higher scores on patient-clinician communication, (for surgeon), subjective decision quality for locoregional treatment, patient centered communication and values concordant treatment.

EXPLORATORY OBJECTIVES:
I. To evaluate whether the enhanced iCanDecide (iCanDecide-ESE) intervention is more effective than the standard version (iCanDecide-S) resulting in higher patient knowledge about systemic treatment decision making, higher breast cancer self-efficacy and lower cancer worry. (Systemic Treatment Decision Making)
II. To evaluate whether the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient knowledge about systemic treatment decision making, higher breast cancer self-efficacy and lower cancer worry. (Systemic Treatment Decision Making)
III. To evaluate whether the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient appraisal of patient centered communication (patient-clinician communication for the oncologist, appraisal of patient-centered communication [PCC], subjective decision quality for systemic treatment). (Systemic Treatment Decision Making)
IV. To evaluate whether the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient appraisal of patient centered communication (patient-clinician communication for the oncologist, appraisal of PCC, subjective decision quality for systemic treatment). (Systemic Treatment Decision Making)
V. To evaluate whether the enhanced iCanDecide (iCanDecide-ESE) intervention is more effective than the standard version (iCanDecide-S) resulting in higher patient reported Quality of Life. (Quality of Life)
VI. To evaluate whether the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient reported Quality of Life. (Quality of Life)
VII. To explore potential synergistic effects of the two interventions combined (i.e., interaction of iCanDecide-ESE and CDB effects) on primary and key secondary objectives. (Synergistic Effects)
VIII. To examine mediators of the primary endpoint (knowledge about locoregional treatment) and key secondary endpoints (cancer worry, self-efficacy) and to examine the association between primary and key secondary endpoints and global appraisal of PCC (additional endpoints) assessed at the 1st follow up assessment. (Mediation Analysis)
IX. To conduct a process evaluation guided by the Consolidated Framework for Implementation Research (CFIR) of the two intervention components (patient facing decision tool, clinician dashboard) including qualitative feedback from both patients and clinicians regarding their user experience and paradata (e.g., time on page) to inform scalability and future implementation of the system. (Process Evaluation)

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients utilize the iCanDecide - ESE website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.

ARM II: Patients utilize the iCanDecide - S website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.

After study registration, patients are followed up at 4-5 weeks and 9 months.

CLINICIANS:

Clinicians' practices are randomized for to time period for use of the CDB.

CLINICS 1-5: Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 1-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

CLINICS 6-8: Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 10-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

CLINICS 9-11: Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 20-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

CLINICS 12-14: Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 30-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

CLINICS 15-17: Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 40-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

CLINICS 18-20: Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 50-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

CLINICS 21-25: Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and continue to provide breast cancer surgical care per their usual care. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

After study registration, clinicians are followed up at 5 weeks and at 9 and 18 months.

Eligibility

1. PATIENT ELIGIBILITY
2. Women newly diagnosed with stage 0-III breast cancer. Although men are recommended to undergo surgery to treat breast cancer, male breast cancer is relatively rare and decision making for breast cancer surgery is quite different between men and women
3. Planning breast surgery as a component of their definitive treatment
4. Receives care from a clinician and at a practice that has consented to participate in the clinician dashboard practice-level intervention. Practices/clinicians will consent initially at the initiation of the study. Patients will then be identified and recruited in those practices. If a practice has more than one clinician doing breast surgery, patients will be recruited from those clinicians who consent (one or more). Patients of clinicians who have not consented will not be eligible
5. Patients must be able to speak English or Spanish with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter). Sites seeking to enroll Spanish- speaking patients must have Spanish speaking staff on site or through the use of a translation service to be able to conduct the informed consent discussion in Spanish
6. Age 21-84 years
7. CLINICIAN STAKEHOLDER (SURGEONS AND CLINIC STAFF) ELIGIBILITY CRITERIA
8. Clinicians eligible for this study include: breast surgeons and their designee(s) (e.g., physician assistants, nurse practitioners, clinical nurse specialists, or nurses) that participate in the treatment decision-making process. At least one surgeon at a practice must agree to participate and sign consent. S/he may then also identify a nurse, physician assistant (PA) or advanced practice provider (APP) with whom s/he works that is involved in the delivery of the care of the same patients to participate. Henceforth, in this protocol they will be referred to as “clinicians”
9. Clinicians must agree to have their patients recruited for the entire time the study is open at their practice, which will include time periods in which the clinicians will and time periods in which they will not have access to the CDB
10. PRACTICE ELIGIBILITY:
11. Practices that annually provide surgical care for over 100 patients newly diagnosed with breast cancer are eligible to participate in this study
12. Eligible practices must have at least one surgeon who agrees to participate in the study
13. CLINICAL RESEARCH ASSISTANT/RESEARCH STAFF ELIGIBILITY
14. Participants must have worked on the SharES study to participate in these interviews