Zvýšení zapojení pacientů do rozhodování o chirurgii rakoviny prsu
Zvýšení zapojení socioekonomicky znevýhodněných pacientek do chirurgie rakoviny prsu Rozhodování prostřednictvím sdílené rozhodovací intervence
This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
The primary and secondary objectives of the study:
PRIMARY OBJECTIVES:
I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient engagement in decision making (measured by knowledge and power) in clinics serving a high proportion of socioeconomically disadvantaged patients.
II. Test the extent to which the effect of a decision aid on patient engagement is mediated through the mitigation of barriers and determine if persistent barriers are disproportionately experienced by socioeconomically disadvantaged patients.
SECONDARY OBJECTIVES:
I. Characterize how persistent barriers influence patient engagement in decision making in order to identify targets for adjunct interventions that could be implemented in clinics serving a high proportion of socioeconomically disadvantaged patients.
Trial Design:
OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Ten clinics will be recruited for participation. All clinics will begin in the usual care arm. Clinics will be randomized to the timing with which they cross-over to the decision aid intervention, with new clinics crossing over every 10 weeks.
ARM I: usual care
ARM II: decision aid intervention
The only difference between patients enrolled before institutional crossover and patients enrolled after institutional crossover is those who are enrolled after institutional crossover will have been offered the decision aid as accepted practice in the clinic.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Tamuning, Guam, 96913
- FHP Health Center-Guam
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San Juan, Portoriko, 00902
- Pan American Center for Oncology Trials LLC
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California
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Dublin, California, Spojené státy, 94568
- Epic Care-Dublin
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Emeryville, California, Spojené státy, 94608
- Bay Area Breast Surgeons Inc
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Emeryville, California, Spojené státy, 94608
- Epic Care Partners in Cancer Care
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Martinez, California, Spojené státy, 94553-3156
- Contra Costa Regional Medical Center
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Oakland, California, Spojené státy, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Spojené státy, 94609
- Bay Area Tumor Institute
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Walnut Creek, California, Spojené státy, 94597
- Epic Care Cyberknife Center
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Georgia
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Augusta, Georgia, Spojené státy, 30912
- Augusta University Medical Center
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Hawaii
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Honolulu, Hawaii, Spojené státy, 96813
- Queen's Medical Center
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Honolulu, Hawaii, Spojené státy, 96817
- The Cancer Center of Hawaii-Liliha
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Honolulu, Hawaii, Spojené státy, 96813
- Hawaii Cancer Care Inc - Waterfront Plaza
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Honolulu, Hawaii, Spojené státy, 96813
- Queen's Cancer Cenrer - POB I
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Honolulu, Hawaii, Spojené státy, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, Spojené státy, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, Spojené státy, 96817
- Hawaii Cancer Care Inc-Liliha
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Honolulu, Hawaii, Spojené státy, 96817
- Kuakini Medical Center
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Honolulu, Hawaii, Spojené státy, 96817
- Queen's Cancer Center - Kuakini
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Honolulu, Hawaii, Spojené státy, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Spojené státy, 96813
- Island Urology
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Lihue, Hawaii, Spojené státy, 96766
- Wilcox Memorial Hospital and Kauai Medical Clinic
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‘Aiea, Hawaii, Spojené státy, 96701
- Pali Momi Medical Center
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‘Aiea, Hawaii, Spojené státy, 96701
- Queen's Cancer Center - Pearlridge
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‘Aiea, Hawaii, Spojené státy, 96701
- The Cancer Center of Hawaii-Pali Momi
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‘Aiea, Hawaii, Spojené státy, 96701
- Hawaii Cancer Care - Savio
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Idaho
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Boise, Idaho, Spojené státy, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Caldwell, Idaho, Spojené státy, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Spojené státy, 83814
- Kootenai Health - Coeur d'Alene
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Emmett, Idaho, Spojené státy, 83617
- Walter Knox Memorial Hospital
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Meridian, Idaho, Spojené státy, 83642
- Idaho Urologic Institute-Meridian
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Nampa, Idaho, Spojené státy, 83686
- Saint Alphonsus Medical Center-Nampa
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Post Falls, Idaho, Spojené státy, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Spojené státy, 83864
- Kootenai Cancer Clinic
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- John H Stroger Jr Hospital of Cook County
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Danville, Illinois, Spojené státy, 61832
- Carle on Vermilion
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Effingham, Illinois, Spojené státy, 62401
- Carle Physician Group-Effingham
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Mattoon, Illinois, Spojené státy, 61938
- Carle Physician Group-Mattoon/Charleston
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Urbana, Illinois, Spojené státy, 61801
- Carle Cancer Center
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Urbana, Illinois, Spojené státy, 61801
- The Carle Foundation Hospital
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Louisiana
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New Orleans, Louisiana, Spojené státy, 70121
- Ochsner Medical Center Jefferson
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Montana
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Anaconda, Montana, Spojené státy, 59711
- Community Hospital of Anaconda
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Billings, Montana, Spojené státy, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, Spojené státy, 59715
- Bozeman Deaconess Hospital
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Great Falls, Montana, Spojené státy, 59405
- Great Falls Clinic
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Great Falls, Montana, Spojené státy, 59405
- Benefis Healthcare- Sletten Cancer Institute
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Helena, Montana, Spojené státy, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, Spojené státy, 59901
- Kalispell Regional Medical Center
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Missoula, Montana, Spojené státy, 59804
- Community Medical Hospital
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87102
- University of New Mexico Cancer Center
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Oregon
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Baker City, Oregon, Spojené státy, 97814
- Saint Alphonsus Medical Center-Baker City
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Ontario, Oregon, Spojené státy, 97914
- Saint Alphonsus Medical Center-Ontario
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South Carolina
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Charleston, South Carolina, Spojené státy, 29425
- Medical University of South Carolina
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Virginia
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Richmond, Virginia, Spojené státy, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Spojené státy, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Wisconsin
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Marshfield, Wisconsin, Spojené státy, 54449
- Marshfield Medical Center-Marshfield
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Wyoming
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Cody, Wyoming, Spojené státy, 82414
- Billings Clinic-Cody
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Sheridan, Wyoming, Spojené státy, 82801
- Welch Cancer Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Newly diagnosed with stage 0-III breast cancer
- Eligible patients must be planning breast surgery as a component of their definitive treatment
- Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
- Patients with hearing impairment requiring the use of an interpreter are not eligible for this study
- Patients must be able to speak English with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter)
- CLINIC STAKEHOLDER (SURGEONS AND CLINIC STAFF): Breast surgeon(s) and nursing staff, medical assistant, or mid-level provider at each participating clinic who participates in the care of patients newly diagnosed with breast cancer
- INSTITUTIONAL: 10 clinics that annually provide surgical care for 120-300 patients newly diagnosed with breast cancer will be selected to participate in this study
- INSTITUTIONAL: Surgeons at eligible clinics must consent to the study as a requirement for site participation
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Arm I (surgical consultation)
Prior to institutional crossover, participants receive care as per usual care. |
Usual Care |
|
Experimentální: Arm II (web-based breast cancer surgery decision aid)
Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation.. |
Usual Care Web-based decision aid received prior to the surgical consultation |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Patient Power: Self-efficacy in Patient Physician Interactions
Časové okno: 3 weeks
|
Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation. |
3 weeks
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Patient Power: Active Patient Participation
Časové okno: 1 day
|
Power is also separately measured by the validated Active Patient Participation Behaviors System to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a summary measure of patient's active involvement in the interaction is coded by the study team and represents a total count of patients' communicative behaviors (i.e., count of patient asking questions, count of patient assertive responses and count of patient expressions of concern) ranging from 0-114, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration). |
1 day
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Patient Knowledge
Časové okno: Up to 3 weeks
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Patient knowledge is measured from 5 knowledge questions in the Decision Quality Instrument-Breast Surgery survey, with a percent correct recorded as the secondary outcome measure, ranging from 0-100%. The patient completes the Decision Quality Instrument-Breast Surgery survey within 3 weeks post-surgical consultation. |
Up to 3 weeks
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Percentage of Concordant Between Surgery Received and Patient Treatment Preference
Časové okno: Up to 3 weeks
|
This binary outcome indicates whether the surgery received (mastectomy or lumpectomy) was concordant with the patient's treatment preference. Patient's goals/concerns (keep the breast, remove the breast for peace of mind, avoid radiation), rated from 0 (not at all important) to 10 (extremely important), and treatment preference (lumpectomy only, lumpectomy and radiation, mastectomy, other surgery, or not sure) are measured with the Decision Quality Instrument (DQI)-Breast Surgery survey, completed within 3 weeks post-consultation. Concordance is derived using the method of Sepucha et al. (2012): (1) estimate a predicted probability (pp) of surgery preference from a multivariable logistic regression model with patient's goals/concerns and stage as independent variables; (2) classify patients as concordant if pp >= 0.5 and mastectomy was received, or pp < 0.5 and lumpectomy was received; and (3) calculate the percentage of concordant. |
Up to 3 weeks
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Heather B. Neuman,, MD, MS, University of Wisconsin, Madison
Publikace a užitečné odkazy
Obecné publikace
- Schumacher JR, Zahrieh D, Chow S, Taylor J, Wills R, Hanlon BM, Rathouz PJ, Tucholka JL, Neuman HB. Increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making through a shared decision-making intervention (A231701CD): protocol for a cluster randomised clinical trial. BMJ Open. 2022 Nov 17;12(11):e063895. doi: 10.1136/bmjopen-2022-063895.
- Schumacher JR, Hanlon BM, Zahrieh D, Rathouz PJ, Tucholka JL, McKinney G, Tan AD, Breuer CR, Bailey L, Higham AM, Wecsler JS, Arnold AH, Froix AJ, Dull S, Abbott AM, Fine SG, McGuire KP, Seydel AS, McNamara P, Chow S, Neuman HB. Impact of a Web-Based Decision Aid on Socioeconomically Disadvantaged Patients' Engagement in Breast Surgery Decision-Making: Stepped-Wedge Clinical Trial (Alliance-A231701CD). Ann Surg Oncol. 2025 Aug;32(8):5540-5550. doi: 10.1245/s10434-025-17452-0. Epub 2025 May 17.
- Saucke MC, Jacobson N, McKinney G, Neuman HB. Role of the Surgeon in De-Escalating Emotion During a Breast Cancer Surgery Consultation: A Qualitative Study of Patients' Experiences in Alliance A231701CD. Ann Surg Oncol. 2024 Dec;31(13):8873-8881. doi: 10.1245/s10434-024-16156-1. Epub 2024 Sep 25.
- Zahrieh D, Croghan IT, Inselman JW, Mandrekar SJ. Guidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies. Mayo Clin Proc. 2023 Nov;98(11):1712-1726. doi: 10.1016/j.mayocp.2023.02.019.
- Saucke MC, Jacobson N, Chow S, McKinney G, Neuman HB. Providing information to prepare breast cancer patients for their surgical consultation: barriers and recommendations (an analysis from Alliance A231701CD). Support Care Cancer. 2026 May 14;34(6):537. doi: 10.1007/s00520-026-10726-7.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- A231701CD
- NCI-2018-00643 (Identifikátor registru: NCI Clinical Trial Reporting Program)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Časový rámec sdílení IPD
Beginning 6 to 12 months following article publication.
Kritéria přístupu pro sdílení IPD
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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