Forbedring af patientcentreret kommunikation i brystkræft gennem patient- og udbyderinterventioner (SHARES)
Forbedring af patientcentreret kommunikation i brystkræft: 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.
Studieoversigt
Status
Betingelser
- Anatomisk fase I brystkræft AJCC v8
- Anatomisk fase IA brystkræft AJCC v8
- Anatomisk fase IB brystkræft AJCC v8
- Anatomisk fase II brystkræft AJCC v8
- Anatomisk fase IIA brystkræft AJCC v8
- Anatomisk fase IIB brystkræft AJCC v8
- Anatomisk fase III brystkræft AJCC v8
- Anatomisk fase IIIA brystkræft AJCC v8
- Anatomisk fase IIIB brystkræft AJCC v8
- Anatomisk fase IIIC brystkræft AJCC v8
- Prognostisk fase I brystkræft AJCC v8
- Prognostisk stadium IA brystkræft AJCC v8
- Prognostisk stadium IB brystkræft AJCC v8
- Prognostisk fase II brystkræft AJCC v8
- Prognostisk fase IIA brystkræft AJCC v8
- Prognostisk fase IIB brystkræft AJCC v8
- Prognostisk fase III brystkræft AJCC v8
- Prognostisk fase IIIA brystkræft AJCC v8
- Prognostisk stadium IIIB brystkræft AJCC v8
- Prognostisk fase IIIC brystkræft AJCC v8
- Anatomisk fase 0 Brystkræft AJCC v8
- Prognostisk fase 0 brystkræft AJCC v8
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
-
Vallejo, California, Forenede Stater, 94589
- Kaiser Permanente-Vallejo
-
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Delaware
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Newark, Delaware, Forenede Stater, 19713
- Helen F Graham Cancer Center
-
Rehoboth Beach, Delaware, Forenede Stater, 19971
- Beebe Health Campus
-
-
Georgia
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Savannah, Georgia, Forenede Stater, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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-
Hawaii
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Honolulu, Hawaii, Forenede Stater, 96819
- Kaiser Permanente Moanalua Medical Center
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Illinois
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Mount Vernon, Illinois, Forenede Stater, 62864
- SSM Health Good Samaritan
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-
Maine
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Scarborough, Maine, Forenede Stater, 04074
- Maine Medical Center- Scarborough Campus
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-
Michigan
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Grand Rapids, Michigan, Forenede Stater, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Forenede Stater, 49048
- Ascension Borgess Hospital
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-
New York
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Mount Kisco, New York, Forenede Stater, 10549
- Northern Westchester Hospital
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New York, New York, Forenede Stater, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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The Bronx, New York, Forenede Stater, 10461
- Montefiore Medical Center-Einstein Campus
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North Carolina
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Greensboro, North Carolina, Forenede Stater, 27403
- Novant Health Breast Surgery - Greensboro
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North Dakota
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Bismarck, North Dakota, Forenede Stater, 58501
- Sanford Bismarck Medical Center
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Fargo, North Dakota, Forenede Stater, 58122
- Sanford Broadway Medical Center
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Ohio
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Chillicothe, Ohio, Forenede Stater, 45601
- Adena Regional Medical Center
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Westerville, Ohio, Forenede Stater, 43081
- Saint Ann's Hospital
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Zanesville, Ohio, Forenede Stater, 43701
- Genesis Healthcare System Cancer Care Center
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38120
- Baptist Memorial Hospital for Women
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Wisconsin
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Appleton, Wisconsin, Forenede Stater, 54911
- ThedaCare Regional Cancer Center
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Eau Claire, Wisconsin, Forenede Stater, 54701
- Marshfield Medical Center-EC Cancer Center
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Grafton, Wisconsin, Forenede Stater, 53024
- Aurora Cancer Care-Grafton
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La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Medical Center
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Wausau, Wisconsin, Forenede Stater, 54401
- Aspirus Regional Cancer Center
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Wauwatosa, Wisconsin, Forenede Stater, 53226
- Ascension Medical Group Southeast Wisconsin - Mayfair Road
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West Allis, Wisconsin, Forenede Stater, 53227
- Aurora West Allis Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm I: (iCanDecide - ESE)
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. |
Ancillary studies Participate in interview Undergo surgery Ancillary studies Utilize the iCanDecide - ESE website |
|
Aktiv komparator: Arm II: (iCanDecide - S)
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. |
Ancillary studies Participate in interview Undergo surgery Ancillary studies Utilize the iCanDecide - S website |
|
Eksperimentel: Clinics 1-5: (CDB)
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. |
Participate in interview Ancillary studies Receive training Utilize the CDB |
|
Eksperimentel: Clinics 6-8 (CDB)
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. |
Participate in interview Ancillary studies Receive training Utilize the CDB |
|
Eksperimentel: Clinics 9-11 (CDB)
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. |
Participate in interview Ancillary studies Receive training Utilize the CDB |
|
Eksperimentel: Clinics 12-14 (CDB)
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. |
Participate in interview Ancillary studies Receive training Utilize the CDB |
|
Eksperimentel: Clinics 15-17 (CDB)
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. |
Participate in interview Ancillary studies Receive training Utilize the CDB |
|
Eksperimentel: Clinics 18-20 (CDB)
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. |
Participate in interview Ancillary studies Receive training Utilize the CDB |
|
Aktiv komparator: Clinics 21-25 (usual care)
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. |
Participate in interview Ancillary studies Receive training Utilize usual care |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient Knowledge About Risks and Benefits of Local Regional Treatment
Tidsramme: 5 weeks
|
Will be defined as the mean 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. |
5 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient Self-efficacy in Dealing With Breast Cancer
Tidsramme: 5 weeks
|
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. |
5 weeks
|
|
Patient Cancer Worry
Tidsramme: 5 weeks
|
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. |
5 weeks
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Sarah T. Hawley, PhD, MPH, University of Michigan School of Medicine and Public Health
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Hudsygdomme
- Brystsygdomme
- Karcinom
- Brystneoplasmer
- Karcinom in situ
- Hud- og bindevævssygdomme
- Brystkarcinom in situ
- Sundhedstjenester Administration
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Undersøgelsesteknikker
- Epidemiologiske metoder
- Dataindsamling
- Evalueringsmekanismer til sundhedsvæsenet
- Sundhedskvalitet
- Folkesundhed
- Miljø og folkesundhed
- Retningslinjer som emne
- Kvalitetssikring, sundhedsvæsen
- Interviews som emne
- Øv retningslinjer som emne
Andre undersøgelses-id-numre
- A231901CD
- NCI-2020-06176 (Registry Identifier: NCI Clinical Trial Reporting Program)
- UG1CA189823 (U.S. NIH-bevilling/kontrakt)
- R01CA237046 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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