NCT04549571Active, not recruiting
Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider Interventions
Improving Patient-Centered Communication in Breast Cancer: A RCT of a Shared Decision Engagement System (SHARES)
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 614 (actual)
- First submitted
- 9 Sept 2020
- Start date
- 16 Feb 2021
- Primary completion date
- 1 May 2024
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Diseases
- Childhood cancers
- NCT number
- NCT04549571
What you commit to
- Study type: Interventional
- Participants enrolled: 614
- From 16 Feb 2021 to the primary completion date, 1 May 2024
- 27 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
Other
- 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
- Practices currently enrolling to Alliance A231701CD are not eligible to participate in this study
Who the study is looking for
- 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
Sex: Female · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ThedaCare Regional Cancer Center Coordinator of this site? Confirm its status | Appleton | United States | Unknown status |
| Sanford Bismarck Medical Center Coordinator of this site? Confirm its status | Bismarck | United States | Unknown status |
| Adena Regional Medical Center Coordinator of this site? Confirm its status | Chillicothe | United States | Unknown status |
| Marshfield Medical Center-EC Cancer Center Coordinator of this site? Confirm its status | Eau Claire | United States | Unknown status |
| Sanford Broadway Medical Center Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Aurora Cancer Care-Grafton Coordinator of this site? Confirm its status | Grafton | United States | Unknown status |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Novant Health Breast Surgery - Greensboro Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Kaiser Permanente Moanalua Medical Center Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| West Michigan Cancer Center Coordinator of this site? Confirm its status | Kalamazoo | United States | Unknown status |
| Ascension Borgess Hospital Coordinator of this site? Confirm its status | Kalamazoo | United States | Unknown status |
| Gundersen Lutheran Medical Center Coordinator of this site? Confirm its status | La Crosse | United States | Unknown status |
| Baptist Memorial Hospital for Women Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Northern Westchester Hospital Coordinator of this site? Confirm its status | Mount Kisco | United States | Unknown status |
| SSM Health Good Samaritan Coordinator of this site? Confirm its status | Mount Vernon | United States | Unknown status |
| Helen F Graham Cancer Center Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Beebe Health Campus Coordinator of this site? Confirm its status | Rehoboth Beach | United States | Unknown status |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Maine Medical Center- Scarborough Campus Coordinator of this site? Confirm its status | Scarborough | United States | Unknown status |
| Montefiore Medical Center-Einstein Campus Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Kaiser Permanente-Vallejo Coordinator of this site? Confirm its status | Vallejo | United States | Unknown status |
| Aspirus Regional Cancer Center Coordinator of this site? Confirm its status | Wausau | United States | Unknown status |
| Ascension Medical Group Southeast Wisconsin - Mayfair Road Coordinator of this site? Confirm its status | Wauwatosa | United States | Unknown status |
| Aurora West Allis Medical Center Coordinator of this site? Confirm its status | West Allis | United States | Unknown status |
| Saint Ann's Hospital Coordinator of this site? Confirm its status | Westerville | United States | Unknown status |
| Genesis Healthcare System Cancer Care Center Coordinator of this site? Confirm its status | Zanesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.