Zlepšení komunikace zaměřené na pacienta u rakoviny prsu prostřednictvím intervencí pacienta a poskytovatele (SHARES)
Zlepšení komunikace zaměřené na pacienta u rakoviny prsu: RCT systému sdíleného rozhodování (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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
- Anatomické stadium I rakoviny prsu AJCC v8
- Anatomický karcinom prsu stadia IA AJCC v8
- Anatomické stadium IB rakoviny prsu AJCC v8
- Anatomický karcinom prsu stadia II AJCC v8
- Anatomický karcinom prsu stadia IIA AJCC v8
- Anatomický karcinom prsu stadia IIB AJCC v8
- Anatomický karcinom prsu stadia III AJCC v8
- Anatomický karcinom prsu stadia IIIA AJCC v8
- Anatomický karcinom prsu stadia IIIB AJCC v8
- Anatomický karcinom prsu stadia IIIC AJCC v8
- Prognostické stadium I rakoviny prsu AJCC v8
- Prognostické stadium IA karcinomu prsu AJCC v8
- Prognostické stadium IB rakoviny prsu AJCC v8
- Prognostická fáze II rakoviny prsu AJCC v8
- Prognostické stadium IIA karcinomu prsu AJCC v8
- Prognostický karcinom prsu stadia IIB AJCC v8
- Prognostická fáze III rakoviny prsu AJCC v8
- Prognostický karcinom prsu stadia IIIA AJCC v8
- Prognostické stadium IIIB rakoviny prsu AJCC v8
- Prognostické stadium IIIC rakoviny prsu AJCC v8
- Anatomické stadium 0 rakoviny prsu AJCC v8
- Prognostické stadium 0 Rakovina prsu AJCC v8
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
California
-
Vallejo, California, Spojené státy, 94589
- Kaiser Permanente-Vallejo
-
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Delaware
-
Newark, Delaware, Spojené státy, 19713
- Helen F Graham Cancer Center
-
Rehoboth Beach, Delaware, Spojené státy, 19971
- Beebe Health Campus
-
-
Georgia
-
Savannah, Georgia, Spojené státy, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
-
-
Hawaii
-
Honolulu, Hawaii, Spojené státy, 96819
- Kaiser Permanente Moanalua Medical Center
-
-
Illinois
-
Mount Vernon, Illinois, Spojené státy, 62864
- SSM Health Good Samaritan
-
-
Maine
-
Scarborough, Maine, Spojené státy, 04074
- Maine Medical Center- Scarborough Campus
-
-
Michigan
-
Grand Rapids, Michigan, Spojené státy, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Kalamazoo, Michigan, Spojené státy, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Spojené státy, 49048
- Ascension Borgess Hospital
-
-
New York
-
Mount Kisco, New York, Spojené státy, 10549
- Northern Westchester Hospital
-
New York, New York, Spojené státy, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
The Bronx, New York, Spojené státy, 10461
- Montefiore Medical Center-Einstein Campus
-
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North Carolina
-
Greensboro, North Carolina, Spojené státy, 27403
- Novant Health Breast Surgery - Greensboro
-
-
North Dakota
-
Bismarck, North Dakota, Spojené státy, 58501
- Sanford Bismarck Medical Center
-
Fargo, North Dakota, Spojené státy, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Chillicothe, Ohio, Spojené státy, 45601
- Adena Regional Medical Center
-
Westerville, Ohio, Spojené státy, 43081
- Saint Ann's Hospital
-
Zanesville, Ohio, Spojené státy, 43701
- Genesis Healthcare System Cancer Care Center
-
-
Tennessee
-
Memphis, Tennessee, Spojené státy, 38120
- Baptist Memorial Hospital for Women
-
-
Wisconsin
-
Appleton, Wisconsin, Spojené státy, 54911
- ThedaCare Regional Cancer Center
-
Eau Claire, Wisconsin, Spojené státy, 54701
- Marshfield Medical Center-EC Cancer Center
-
Grafton, Wisconsin, Spojené státy, 53024
- Aurora Cancer Care-Grafton
-
La Crosse, Wisconsin, Spojené státy, 54601
- Gundersen Lutheran Medical Center
-
Wausau, Wisconsin, Spojené státy, 54401
- Aspirus Regional Cancer Center
-
Wauwatosa, Wisconsin, Spojené státy, 53226
- Ascension Medical Group Southeast Wisconsin - Mayfair Road
-
West Allis, Wisconsin, Spojené státy, 53227
- Aurora West Allis Medical Center
-
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Dvojnásobek
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: 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 |
|
Aktivní komparátor: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Experimentální: 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 |
|
Aktivní komparátor: 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 |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Patient Knowledge About Risks and Benefits of Local Regional Treatment
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Patient Self-efficacy in Dealing With Breast Cancer
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Sarah T. Hawley, PhD, MPH, University of Michigan School of Medicine and Public Health
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle místa
- Novotvary
- Novotvary podle histologického typu
- Novotvary, žlázové a epiteliální
- Kožní choroby
- Nemoci prsu
- Karcinom
- Novotvary prsu
- Karcinom in situ
- Onemocnění kůže a pojivové tkáně
- Karcinom Prsu In Situ
- Správa zdravotnických služeb
- Kvalita zdravotní péče, přístup a hodnocení
- Vyšetřovací techniky
- Epidemiologické metody
- Sběr dat
- Mechanismy hodnocení zdravotní péče
- Kvalita zdravotní péče
- Veřejné zdraví
- Životní prostředí a veřejné zdraví
- Pokyny jako téma
- Zajištění kvality, zdravotní péče
- Rozhovory jako téma
- Procvičujte pokyny jako téma
Další identifikační čísla studie
Další identifikační čísla studie
- A231901CD
- NCI-2020-06176 (Identifikátor registru: NCI Clinical Trial Reporting Program)
- UG1CA189823 (Grant/smlouva NIH USA)
- R01CA237046 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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