Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial
— SHARESOfficial title:
Improving Patient-Centered Communication in Breast Cancer: A RCT of a Shared Decision Engagement System (SHARES)
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.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | January 2027 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - PATIENT ELIGIBILITY - 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 - Planning breast surgery as a component of their definitive treatment within 5 weeks of registration - 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 - 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) - Age 21-84 years - CLINICIAN STAKEHOLDER (SURGEONS AND CLINIC STAFF) ELIGIBILITY CRITERIA - 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 surgical oncologist 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" - 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 - INSTITUTION ELIGIBILITY: - Practices that annually provide surgical care for over 100 patients newly diagnosed with breast cancer are eligible to participate in this study - Eligible practices must have at least one surgical oncologist who agrees to participate in the study Exclusion Criteria: - Patients who are visually impaired are not eligible, as they must be able to access the study intervention on a website at home or in clinic and view the decision aid - Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study - Practices currently enrolling to Alliance A231701CD are not eligible to participate in this study |
Country | Name | City | State |
---|---|---|---|
United States | ThedaCare Regional Cancer Center | Appleton | Wisconsin |
United States | Sanford Bismarck Medical Center | Bismarck | North Dakota |
United States | Montefiore Medical Center-Einstein Campus | Bronx | New York |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin |
United States | Sanford Broadway Medical Center | Fargo | North Dakota |
United States | Aurora Cancer Care-Grafton | Grafton | Wisconsin |
United States | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan |
United States | Novant Health Breast Surgery - Greensboro | Greensboro | North Carolina |
United States | Kaiser Permanente Moanalua Medical Center | Honolulu | Hawaii |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
United States | Baptist Memorial Hospital for Women | Memphis | Tennessee |
United States | Northern Westchester Hospital | Mount Kisco | New York |
United States | Good Samaritan Regional Health Center | Mount Vernon | Illinois |
United States | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | Helen F Graham Cancer Center | Newark | Delaware |
United States | Beebe Health Campus | Rehoboth Beach | Delaware |
United States | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia |
United States | Maine Medical Center- Scarborough Campus | Scarborough | Maine |
United States | Kaiser Permanente-Vallejo | Vallejo | California |
United States | Aspirus Regional Cancer Center | Wausau | Wisconsin |
United States | Ascension Medical Group Southeast Wisconsin - Mayfair Road | Wauwatosa | Wisconsin |
United States | Aurora West Allis Medical Center | West Allis | Wisconsin |
United States | Saint Ann's Hospital | Westerville | Ohio |
United States | Genesis Healthcare System Cancer Care Center | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient knowledge about risks and benefits of local regional treatment | Will be defined as the percentage of correct answers (range: 0-100%) from a 5-item scale previously developed and pilot tested where higher percentages indicate increased knowledge of treatment risks and benefits of local regional treatment. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous primary outcome measure patient knowledge. | At 4-5 weeks post patient randomization | |
Secondary | Patient self-efficacy in dealing with breast cancer | Will be defined as the composite score obtained from the 11-item (each rated on a 5-point Likert scale: "strongly disagree" to "strongly agree") validated scale designed to assess breast cancer patients' overall feelings of control of their cancer and worry about their cancer (range: 11 to 55); higher scores indicate increased self-efficacy. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous secondary outcome measure patient self-efficacy. | At 4-5 weeks post patient randomization | |
Secondary | Patient cancer worry | Will be defined as the total score obtained from the 8-item (each rated on a 4-point Likert scale: "never" to "almost always") validated Cancer Worry Scale assessing the degree of cancer-related worry (range: 8 to 40); higher scores indicate more frequent worries about cancer. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous secondary outcome measure patient cancer worry. | At 4-5 weeks post patient randomization |
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