Anatomic Stage 0 Breast Cancer AJCC v8SHARESNCT04549571
Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider Interventions
A study testing Decision Aid iCanDecide - ESE website, Decision Aid iCanDecide - S website and Therapeutic Conventional Surgery in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 27 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
- What is being tested?
- Decision Aid iCanDecide - ESE website, Decision Aid iCanDecide - S website and Therapeutic Conventional Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 543 participants
- Where
- 27 sitesUnited States
- Study dates
- 16 Feb 2021to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Novant Health Breast Surgery - Greensboro
Greensboro, North Carolina, 27403
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Ascension Borgess Hospital
Kalamazoo, Michigan, 49048
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Baptist Memorial Hospital for Women
Memphis, Tennessee, 38120
Northern Westchester Hospital
Mount Kisco, New York, 10549
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Helen F Graham Cancer Center
Newark, Delaware, 19713
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Kaiser Permanente-Vallejo
Vallejo, California, 94589
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, 53226
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Saint Ann's Hospital
Westerville, Ohio, 43081
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701
About this study
Official 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.
Read the detailed description
The primary and key secondary objectives of the study:
PRIMARY OBJECTIVES:
- 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:
- 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 and lower patient reported cancer worry.
OUTLINE: This study is a multi-level trial of SHaDES that has two interventions in a factorial or crossed design: 1) an individually randomized patient-level randomized controlled trial (RCT) to evaluate the standard version (iCanDecide-S) vs. a version with innovative emotional support enhancements (iCanDecide-ESE), and 2) a clinic-level stepped-wedge cluster randomized trial to test a Clinician Dashboard (CDB). Twenty-five surgical practices will be recruited for participation. Practices will be randomized to the timing of the CDB intervention, with some practices initiating the CDB intervention right away, while others may initiate the CDB later or perhaps be randomized to "no CDB" period. Clinicians will be asked to use the CDB beginning in the time period to which their practice was randomized and continuing to the end of the study. After registration, clinicians are followed up at 9 and 18 months. After a patient is registered, the patient will be randomized to one of two 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.
Patients will be enrolled at participating clinics during the full duration of the study and all enrolled patients will receive a version of the decision support tool (iCanDecide-S; iCanDecide-ESE). These patient-level activities are not influenced by the timing of the practice-level randomization to the CDB.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Being tested
- Decision Aid iCanDecide - ESE website, Decision Aid iCanDecide - S website, Therapeutic Conventional Surgery, Interview, Training
- Medical subject headings
- Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Aid iCanDecide - ESE websiteOther
Utilize the iCanDecide - ESE website
Decision Aid iCanDecide - S websiteOther
Utilize the iCanDecide - S website
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgery
InterviewOther
Participate in interview
TrainingOther
Receive training
Media InterventionOther
Utilize the CDB
Best PracticeOther
Utilize usual care
Survey AdministrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I: (iCanDecide - ESE) | Experimental | 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. Receives: Other: Decision Aid iCanDecide - ESE website; Procedure: Therapeutic Conventional Surgery; Other: Interview; Other: Survey Administration; Other: Quality-of-Life Assessment |
| Arm II: (iCanDecide - S) | Active comparator | 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. Receives: Other: Decision Aid iCanDecide - S website; Procedure: Therapeutic Conventional Surgery; Other: Interview; Other: Survey Administration; Other: Quality-of-Life Assessment |
| Clinics 1-5: (CDB) | Experimental | 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. Receives: Other: Interview; Other: Training; Other: Media Intervention; Other: Survey Administration |
| Clinics 6-8 (CDB) | Experimental | 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. Receives: Other: Interview; Other: Training; Other: Media Intervention; Other: Survey Administration |
| Clinics 9-11 (CDB) | Experimental | 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. Receives: Other: Interview; Other: Training; Other: Media Intervention; Other: Survey Administration |
| Clinics 12-14 (CDB) | Experimental | 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. Receives: Other: Interview; Other: Training; Other: Media Intervention; Other: Survey Administration |
| Clinics 15-17 (CDB) | Experimental | 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. Receives: Other: Interview; Other: Training; Other: Media Intervention; Other: Survey Administration |
| Clinics 18-20 (CDB) | Experimental | 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. Receives: Other: Interview; Other: Training; Other: Media Intervention; Other: Survey Administration |
| Clinics 21-25 (usual care) | Active comparator | 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. Receives: Other: Interview; Other: Training; Other: Best Practice; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 4-5 weeks post patient randomization
Secondary outcomes (2)
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.
Measured: At 4-5 weeks post patient randomization
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.
Measured: At 4-5 weeks post patient randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start16 Feb 2021
- Primary completion1 May 2024
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anatomic Stage 0 Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sarah T. Hawley, PhD, MPH, Study chair, University of Michigan School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549571
- Sponsor's protocol ID
- A231901CD
- Other IDs
- NCI-2020-06176, UG1CA189823, R01CA237046
- Acronym
- SHARES
- Status last verified
- Mar 2025
- First submitted
- 9 Sep 2020
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hawley ST, Kidwell KM, Jagsi R, Barber AK, Wills R, Chow SL, Kour O, Segovia D, Abrahamse P, Resnicow K, Zikmund-Fisher BJ, Hofer TP, Neuman HB. Evaluating a shared decision engagement system in the NCI community oncology research program: a multi-level RCT. JNCI Cancer Spectr. 2026 Sep 28:pkag100. doi: 10.1093/jncics/pkag100. Online ahead of print.
PubMed 42804742Hawley ST, Kidwell K, Zahrieh D, McCarthy A, Wills R, Rankin A, Hofer T, Chow S, Jagsi R, Neuman H. Improving patient-centered communication in breast cancer: a study protocol for a multilevel intervention of a shared treatment deliberation system (SharES) within the NCI community oncology research program (NCORP) (Alliance A231901CD). Trials. 2023 Jan 6;24(1):16. doi: 10.1186/s13063-022-07048-4.
PubMed 36609349
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient-Centered Communication in Breast Cancer: A RCT of a Shared Decision Engagement System (SHARES)
- ClinicalTrials.gov ID
- NCT04549571
- Acronym / sponsor ID
- SHARES / A231901CD
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary and key secondary objectives of the study:
PRIMARY OBJECTIVES:
- 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:
- 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 and lower patient reported cancer worry.
OUTLINE: This study is a multi-level trial of SHaDES that has two interventions in a factorial or crossed design: 1) an individually randomized patient-level randomized controlled trial (RCT) to evaluate the standard version (iCanDecide-S) vs. a version with innovative emotional support enhancements (iCanDecide-ESE), and 2) a clinic-level stepped-wedge cluster randomized trial to test a Clinician Dashboard (CDB). Twenty-five surgical practices will be recruited for participation. Practices will be randomized to the timing of the CDB intervention, with some practices initiating the CDB intervention right away, while others may initiate the CDB later or perhaps be randomized to "no CDB" period. Clinicians will be asked to use the CDB beginning in the time period to which their practice was randomized and continuing to the end of the study. After registration, clinicians are followed up at 9 and 18 months. After a patient is registered, the patient will be randomized to one of two 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.
Patients will be enrolled at participating clinics during the full duration of the study and all enrolled patients will receive a version of the decision support tool (iCanDecide-S; iCanDecide-ESE). These patient-level activities are not influenced by the timing of the practice-level randomization to the CDB.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Arm I: (iCanDecide - ESE) | Experimental | Other: Decision Aid iCanDecide - ESE website, Procedure: Therapeutic Conventional Surgery, Other: Interview, Other: Survey Administration, Other: Quality-of-Life AssessmentPatients 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: (iCanDecide - S) | Active comparator | Other: Decision Aid iCanDecide - S website, Procedure: Therapeutic Conventional Surgery, Other: Interview, Other: Survey Administration, Other: Quality-of-Life AssessmentPatients 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. |
| Clinics 1-5: (CDB) | Experimental | Other: Interview, Other: Training, Other: Media Intervention, Other: Survey AdministrationBeginning 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 (CDB) | Experimental | Other: Interview, Other: Training, Other: Media Intervention, Other: Survey AdministrationBeginning 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 (CDB) | Experimental | Other: Interview, Other: Training, Other: Media Intervention, Other: Survey AdministrationBeginning 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 (CDB) | Experimental | Other: Interview, Other: Training, Other: Media Intervention, Other: Survey AdministrationBeginning 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 (CDB) | Experimental | Other: Interview, Other: Training, Other: Media Intervention, Other: Survey AdministrationBeginning 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 (CDB) | Experimental | Other: Interview, Other: Training, Other: Media Intervention, Other: Survey AdministrationBeginning 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 (usual care) | Active comparator | Other: Interview, Other: Training, Other: Best Practice, Other: Survey AdministrationBeginning 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision Aid iCanDecide - ESE websiteUtilize the iCanDecide - ESE website | Other | Arm I: (iCanDecide - ESE) |
| Decision Aid iCanDecide - S websiteUtilize the iCanDecide - S website | Other | Arm II: (iCanDecide - S) |
| Therapeutic Conventional SurgeryUndergo surgery | Procedure or surgery | Arm I: (iCanDecide - ESE), Arm II: (iCanDecide - S) |
| InterviewParticipate in interview | Other | Arm I: (iCanDecide - ESE), Arm II: (iCanDecide - S), Clinics 1-5: (CDB), Clinics 12-14 (CDB), Clinics 15-17 (CDB), Clinics 18-20 (CDB), Clinics 21-25 (usual care), Clinics 6-8 (CDB), Clinics 9-11 (CDB) |
| TrainingReceive training | Other | Clinics 1-5: (CDB), Clinics 12-14 (CDB), Clinics 15-17 (CDB), Clinics 18-20 (CDB), Clinics 21-25 (usual care), Clinics 6-8 (CDB), Clinics 9-11 (CDB) |
| Media InterventionUtilize the CDB | Other | Clinics 1-5: (CDB), Clinics 12-14 (CDB), Clinics 15-17 (CDB), Clinics 18-20 (CDB), Clinics 6-8 (CDB), Clinics 9-11 (CDB) |
| Best PracticeUtilize usual care | Other | Clinics 21-25 (usual care) |
| Survey AdministrationAncillary studies | Other | Arm I: (iCanDecide - ESE), Arm II: (iCanDecide - S), Clinics 1-5: (CDB), Clinics 12-14 (CDB), Clinics 15-17 (CDB), Clinics 18-20 (CDB), Clinics 21-25 (usual care), Clinics 6-8 (CDB), Clinics 9-11 (CDB) |
| Quality-of-Life AssessmentAncillary studies | Other | Arm I: (iCanDecide - ESE), Arm II: (iCanDecide - S) |
Primary outcome
Patient knowledge about risks and benefits of local regional treatment
Time frame: At 4-5 weeks post patient randomization
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.
2 secondary outcomes
Patient self-efficacy in dealing with breast cancer
Time frame: At 4-5 weeks post patient randomization
Patient cancer worry
Time frame: At 4-5 weeks post patient randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 42804742Hawley ST, Kidwell KM, Jagsi R, Barber AK, Wills R, Chow SL, Kour O, Segovia D, Abrahamse P, Resnicow K, Zikmund-Fisher BJ, Hofer TP, Neuman HB. Evaluating a shared decision engagement system in the NCI community oncology research program: a multi-level RCT. JNCI Cancer Spectr. 2026 Sep 28:pkag100. doi: 10.1093/jncics/pkag100. Online ahead of print.
- Derived from this study: PubMed 36609349Hawley ST, Kidwell K, Zahrieh D, McCarthy A, Wills R, Rankin A, Hofer T, Chow S, Jagsi R, Neuman H. Improving patient-centered communication in breast cancer: a study protocol for a multilevel intervention of a shared treatment deliberation system (SharES) within the NCI community oncology research program (NCORP) (Alliance A231901CD). Trials. 2023 Jan 6;24(1):16. doi: 10.1186/s13063-022-07048-4.
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Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Recruiting
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
RecruitingPhase 2
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Active, not recruiting
Standard Verbal Counseling With or Without a Pictorial Educational Tool for the Reduction of Psychological Morbidity in Patients With Stage 0-IIIA Breast Cancer Receiving Radiation Therapy, COPE Study
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Active, not recruiting
Hypnosedation in Relaxing Patients Undergoing Breast Cancer Surgery
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah T. Hawley, PhD, MPH study chair
University of Michigan School of Medicine and Public Health
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid iCanDecide - ESE website, Decision Aid iCanDecide - S website and Therapeutic Conventional Surgery in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient knowledge about risks and benefits of local regional treatment (time frame: At 4-5 weeks post patient randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04549571, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.