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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
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

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ThedaCare Regional Cancer Center
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AppletonUnited StatesUnknown status
Sanford Bismarck Medical Center
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BismarckUnited StatesUnknown status
Adena Regional Medical Center
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ChillicotheUnited StatesUnknown status
Marshfield Medical Center-EC Cancer Center
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Eau ClaireUnited StatesUnknown status
Sanford Broadway Medical Center
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FargoUnited StatesUnknown status
Aurora Cancer Care-Grafton
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GraftonUnited StatesUnknown status
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand RapidsUnited StatesUnknown status
Novant Health Breast Surgery - Greensboro
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GreensboroUnited StatesUnknown status
Kaiser Permanente Moanalua Medical Center
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HonoluluUnited StatesUnknown status
West Michigan Cancer Center
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KalamazooUnited StatesUnknown status
Ascension Borgess Hospital
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KalamazooUnited StatesUnknown status
Gundersen Lutheran Medical Center
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La CrosseUnited StatesUnknown status
Baptist Memorial Hospital for Women
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MemphisUnited StatesUnknown status
Northern Westchester Hospital
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Mount KiscoUnited StatesUnknown status
SSM Health Good Samaritan
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Mount VernonUnited StatesUnknown status
Helen F Graham Cancer Center
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NewarkUnited StatesUnknown status
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New YorkUnited StatesUnknown status
Beebe Health Campus
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Rehoboth BeachUnited StatesUnknown status
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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SavannahUnited StatesUnknown status
Maine Medical Center- Scarborough Campus
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ScarboroughUnited StatesUnknown status
Montefiore Medical Center-Einstein Campus
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The BronxUnited StatesUnknown status
Kaiser Permanente-Vallejo
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VallejoUnited StatesUnknown status
Aspirus Regional Cancer Center
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WausauUnited StatesUnknown status
Ascension Medical Group Southeast Wisconsin - Mayfair Road
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WauwatosaUnited StatesUnknown status
Aurora West Allis Medical Center
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West AllisUnited StatesUnknown status
Saint Ann's Hospital
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WestervilleUnited StatesUnknown status
Genesis Healthcare System Cancer Care Center
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ZanesvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.