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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-06176 | Registry Identifier | NCI Clinical Trial Reporting Program | |
| UG1CA189823 | U.S. NIH Grant/Contract | View source | |
| R01CA237046 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
The primary and key secondary objectives of the study:
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid iCanDecide - ESE website | Other | Utilize the iCanDecide - ESE website |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah T. Hawley, PhD, MPH | University of Michigan School of Medicine and Public Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente-Vallejo | Vallejo | California | 94589 | United States | ||
| Helen F Graham Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36609349 | Derived | Hawley 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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 8, 2025 | |
| Reset | Aug 26, 2025 | |
| Release | Jan 30, 2026 |
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The enhanced content of the ESE version iCanDecide-ESE is available to the patient, but does not populate differently into the CDB, allowing clinicians to remain blinded to the patient-level randomization arm; therefore, both the patient and the practice and clinicians will be blinded as to which arm the patient is assigned to. However, the surgical practices and their clinicians will know when they are using the CDB so the clinician level intervention will not be blinded.
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Decision Aid iCanDecide - S website | Other | Utilize the iCanDecide - S website |
|
| Therapeutic Conventional Surgery | Procedure | Undergo surgery |
|
| Interview | Other | Participate in interview |
|
| Training | Other | Receive training |
|
| Media Intervention | Other | Utilize the CDB |
|
| Best Practice | Other | Utilize usual care |
|
| Survey Administration | Other | Ancillary studies |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
| 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. | At 4-5 weeks post patient randomization |
| Newark |
| Delaware |
| 19713 |
| United States |
| Beebe Health Campus | Rehoboth Beach | Delaware | 19971 | United States |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | 31405 | United States |
| Kaiser Permanente Moanalua Medical Center | Honolulu | Hawaii | 96819 | United States |
| SSM Health Good Samaritan | Mount Vernon | Illinois | 62864 | United States |
| Maine Medical Center- Scarborough Campus | Scarborough | Maine | 04074 | United States |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Ascension Borgess Hospital | Kalamazoo | Michigan | 49048 | United States |
| Northern Westchester Hospital | Mount Kisco | New York | 10549 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | United States |
| Novant Health Breast Surgery - Greensboro | Greensboro | North Carolina | 27403 | United States |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | United States |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Saint Ann's Hospital | Westerville | Ohio | 43081 | United States |
| Genesis Healthcare System Cancer Care Center | Zanesville | Ohio | 43701 | United States |
| Baptist Memorial Hospital for Women | Memphis | Tennessee | 38120 | United States |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | 54911 | United States |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | United States |
| Aurora Cancer Care-Grafton | Grafton | Wisconsin | 53024 | United States |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Aspirus Regional Cancer Center | Wausau | Wisconsin | 54401 | United States |
| Ascension Medical Group Southeast Wisconsin - Mayfair Road | Wauwatosa | Wisconsin | 53226 | United States |
| Aurora West Allis Medical Center | West Allis | Wisconsin | 53227 | United States |
| Reset | Feb 19, 2026 |
| Release | Mar 6, 2026 |
| Reset | Mar 25, 2026 |
| Release | Apr 6, 2026 |
| Reset | Apr 24, 2026 |
| Release | May 7, 2026 |
| Reset | Jun 1, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 8, 2025 | Aug 26, 2025 | |||
| Jan 30, 2026 | Feb 19, 2026 | |||
| Mar 6, 2026 | Mar 25, 2026 | |||
| Apr 6, 2026 | Apr 24, 2026 | |||
| May 7, 2026 | Jun 1, 2026 | |||
| Jun 18, 2026 |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D017410 | Practice Guidelines as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D006298 | Health Services Administration |
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