Steigerung des Patientenengagements bei der Entscheidungsfindung bei Brustkrebsoperationen
Steigerung des Engagements sozioökonomisch benachteiligter Patienten bei der Entscheidungsfindung bei Brustkrebsoperationen durch eine Intervention zur gemeinsamen Entscheidungsfindung
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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Tamuning, Guam, 96913
- FHP Health Center-Guam
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San Juan, Puerto Rico, 00902
- Pan American Center for Oncology Trials LLC
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California
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Dublin, California, Vereinigte Staaten, 94568
- Epic Care-Dublin
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Emeryville, California, Vereinigte Staaten, 94608
- Bay Area Breast Surgeons Inc
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Emeryville, California, Vereinigte Staaten, 94608
- Epic Care Partners in Cancer Care
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Martinez, California, Vereinigte Staaten, 94553-3156
- Contra Costa Regional Medical Center
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Oakland, California, Vereinigte Staaten, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Vereinigte Staaten, 94609
- Bay Area Tumor Institute
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Walnut Creek, California, Vereinigte Staaten, 94597
- Epic Care Cyberknife Center
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Georgia
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Augusta, Georgia, Vereinigte Staaten, 30912
- Augusta University Medical Center
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Hawaii
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Honolulu, Hawaii, Vereinigte Staaten, 96813
- Queen's Medical Center
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Honolulu, Hawaii, Vereinigte Staaten, 96817
- The Cancer Center of Hawaii-Liliha
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Honolulu, Hawaii, Vereinigte Staaten, 96813
- Hawaii Cancer Care Inc - Waterfront Plaza
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Honolulu, Hawaii, Vereinigte Staaten, 96813
- Queen's Cancer Cenrer - POB I
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Honolulu, Hawaii, Vereinigte Staaten, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, Vereinigte Staaten, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, Vereinigte Staaten, 96817
- Hawaii Cancer Care Inc-Liliha
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Honolulu, Hawaii, Vereinigte Staaten, 96817
- Kuakini Medical Center
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Honolulu, Hawaii, Vereinigte Staaten, 96817
- Queen's Cancer Center - Kuakini
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Honolulu, Hawaii, Vereinigte Staaten, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Vereinigte Staaten, 96813
- Island Urology
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Lihue, Hawaii, Vereinigte Staaten, 96766
- Wilcox Memorial Hospital and Kauai Medical Clinic
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‘Aiea, Hawaii, Vereinigte Staaten, 96701
- Pali Momi Medical Center
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‘Aiea, Hawaii, Vereinigte Staaten, 96701
- Queen's Cancer Center - Pearlridge
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‘Aiea, Hawaii, Vereinigte Staaten, 96701
- The Cancer Center of Hawaii-Pali Momi
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‘Aiea, Hawaii, Vereinigte Staaten, 96701
- Hawaii Cancer Care - Savio
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Idaho
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Boise, Idaho, Vereinigte Staaten, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Caldwell, Idaho, Vereinigte Staaten, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Vereinigte Staaten, 83814
- Kootenai Health - Coeur d'Alene
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Emmett, Idaho, Vereinigte Staaten, 83617
- Walter Knox Memorial Hospital
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Meridian, Idaho, Vereinigte Staaten, 83642
- Idaho Urologic Institute-Meridian
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Nampa, Idaho, Vereinigte Staaten, 83686
- Saint Alphonsus Medical Center-Nampa
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Post Falls, Idaho, Vereinigte Staaten, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Vereinigte Staaten, 83864
- Kootenai Cancer Clinic
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60612
- John H Stroger Jr Hospital of Cook County
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Danville, Illinois, Vereinigte Staaten, 61832
- Carle on Vermilion
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Effingham, Illinois, Vereinigte Staaten, 62401
- Carle Physician Group-Effingham
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Mattoon, Illinois, Vereinigte Staaten, 61938
- Carle Physician Group-Mattoon/Charleston
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Urbana, Illinois, Vereinigte Staaten, 61801
- Carle Cancer Center
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Urbana, Illinois, Vereinigte Staaten, 61801
- The Carle Foundation Hospital
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Louisiana
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New Orleans, Louisiana, Vereinigte Staaten, 70121
- Ochsner Medical Center Jefferson
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Montana
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Anaconda, Montana, Vereinigte Staaten, 59711
- Community Hospital of Anaconda
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Billings, Montana, Vereinigte Staaten, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, Vereinigte Staaten, 59715
- Bozeman Deaconess Hospital
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Great Falls, Montana, Vereinigte Staaten, 59405
- Great Falls Clinic
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Great Falls, Montana, Vereinigte Staaten, 59405
- Benefis Healthcare- Sletten Cancer Institute
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Helena, Montana, Vereinigte Staaten, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, Vereinigte Staaten, 59901
- Kalispell Regional Medical Center
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Missoula, Montana, Vereinigte Staaten, 59804
- Community Medical Hospital
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New Mexico
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Albuquerque, New Mexico, Vereinigte Staaten, 87102
- University of New Mexico Cancer Center
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Oregon
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Baker City, Oregon, Vereinigte Staaten, 97814
- Saint Alphonsus Medical Center-Baker City
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Ontario, Oregon, Vereinigte Staaten, 97914
- Saint Alphonsus Medical Center-Ontario
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South Carolina
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Charleston, South Carolina, Vereinigte Staaten, 29425
- Medical University of South Carolina
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Virginia
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Richmond, Virginia, Vereinigte Staaten, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Vereinigte Staaten, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Wisconsin
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Marshfield, Wisconsin, Vereinigte Staaten, 54449
- Marshfield Medical Center-Marshfield
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Wyoming
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Cody, Wyoming, Vereinigte Staaten, 82414
- Billings Clinic-Cody
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Sheridan, Wyoming, Vereinigte Staaten, 82801
- Welch Cancer Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: Arm I (surgical consultation)
Prior to institutional crossover, participants receive care as per usual care. |
Usual Care |
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Experimental: 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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Patient Power: Self-efficacy in Patient Physician Interactions
Zeitfenster: 3 weeks
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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
Zeitfenster: 1 day
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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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Patient Knowledge
Zeitfenster: 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
Zeitfenster: Up to 3 weeks
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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
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Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Heather B. Neuman,, MD, MS, University of Wisconsin, Madison
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- A231701CD
- NCI-2018-00643 (Registrierungskennung: NCI Clinical Trial Reporting Program)
Plan für individuelle Teilnehmerdaten (IPD)
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD-Sharing-Zeitrahmen
Beginning 6 to 12 months following article publication.
IPD-Sharing-Zugriffskriterien
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
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- STUDIENPROTOKOLL
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