Accroître l'engagement des patientes dans la prise de décision en matière de chirurgie du cancer du sein
Accroître l'engagement des patientes défavorisées sur le plan socio-économique dans la prise de décision en matière de chirurgie du cancer du sein grâce à une intervention de prise de décision partagée
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Tamuning, Guam, 96913
- FHP Health Center-Guam
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San Juan, Porto Rico, 00902
- Pan American Center for Oncology Trials LLC
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California
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Dublin, California, États-Unis, 94568
- Epic Care-Dublin
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Emeryville, California, États-Unis, 94608
- Bay Area Breast Surgeons Inc
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Emeryville, California, États-Unis, 94608
- Epic Care Partners in Cancer Care
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Martinez, California, États-Unis, 94553-3156
- Contra Costa Regional Medical Center
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Oakland, California, États-Unis, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, États-Unis, 94609
- Bay Area Tumor Institute
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Walnut Creek, California, États-Unis, 94597
- Epic Care Cyberknife Center
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Georgia
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Augusta, Georgia, États-Unis, 30912
- Augusta University Medical Center
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Hawaii
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Honolulu, Hawaii, États-Unis, 96813
- Queen's Medical Center
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Honolulu, Hawaii, États-Unis, 96817
- The Cancer Center of Hawaii-Liliha
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Honolulu, Hawaii, États-Unis, 96813
- Hawaii Cancer Care Inc - Waterfront Plaza
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Honolulu, Hawaii, États-Unis, 96813
- Queen's Cancer Cenrer - POB I
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Honolulu, Hawaii, États-Unis, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, États-Unis, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, États-Unis, 96817
- Hawaii Cancer Care Inc-Liliha
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Honolulu, Hawaii, États-Unis, 96817
- Kuakini Medical Center
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Honolulu, Hawaii, États-Unis, 96817
- Queen's Cancer Center - Kuakini
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Honolulu, Hawaii, États-Unis, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, États-Unis, 96813
- Island Urology
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Lihue, Hawaii, États-Unis, 96766
- Wilcox Memorial Hospital and Kauai Medical Clinic
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‘Aiea, Hawaii, États-Unis, 96701
- Pali Momi Medical Center
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‘Aiea, Hawaii, États-Unis, 96701
- Queen's Cancer Center - Pearlridge
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‘Aiea, Hawaii, États-Unis, 96701
- The Cancer Center of Hawaii-Pali Momi
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‘Aiea, Hawaii, États-Unis, 96701
- Hawaii Cancer Care - Savio
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Idaho
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Boise, Idaho, États-Unis, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Caldwell, Idaho, États-Unis, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, États-Unis, 83814
- Kootenai Health - Coeur d'Alene
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Emmett, Idaho, États-Unis, 83617
- Walter Knox Memorial Hospital
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Meridian, Idaho, États-Unis, 83642
- Idaho Urologic Institute-Meridian
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Nampa, Idaho, États-Unis, 83686
- Saint Alphonsus Medical Center-Nampa
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Post Falls, Idaho, États-Unis, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, États-Unis, 83864
- Kootenai Cancer Clinic
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Illinois
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Chicago, Illinois, États-Unis, 60612
- John H Stroger Jr Hospital of Cook County
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Danville, Illinois, États-Unis, 61832
- Carle on Vermilion
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Effingham, Illinois, États-Unis, 62401
- Carle Physician Group-Effingham
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Mattoon, Illinois, États-Unis, 61938
- Carle Physician Group-Mattoon/Charleston
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Urbana, Illinois, États-Unis, 61801
- Carle Cancer Center
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Urbana, Illinois, États-Unis, 61801
- The Carle Foundation Hospital
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Louisiana
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New Orleans, Louisiana, États-Unis, 70121
- Ochsner Medical Center Jefferson
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Montana
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Anaconda, Montana, États-Unis, 59711
- Community Hospital of Anaconda
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Billings, Montana, États-Unis, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, États-Unis, 59715
- Bozeman Deaconess Hospital
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Great Falls, Montana, États-Unis, 59405
- Great Falls Clinic
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Great Falls, Montana, États-Unis, 59405
- Benefis Healthcare- Sletten Cancer Institute
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Helena, Montana, États-Unis, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, États-Unis, 59901
- Kalispell Regional Medical Center
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Missoula, Montana, États-Unis, 59804
- Community Medical Hospital
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87102
- University of New Mexico Cancer Center
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Oregon
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Baker City, Oregon, États-Unis, 97814
- Saint Alphonsus Medical Center-Baker City
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Ontario, Oregon, États-Unis, 97914
- Saint Alphonsus Medical Center-Ontario
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina
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Virginia
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Richmond, Virginia, États-Unis, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, États-Unis, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Wisconsin
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Marshfield, Wisconsin, États-Unis, 54449
- Marshfield Medical Center-Marshfield
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Wyoming
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Cody, Wyoming, États-Unis, 82414
- Billings Clinic-Cody
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Sheridan, Wyoming, États-Unis, 82801
- Welch Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Arm I (surgical consultation)
Prior to institutional crossover, participants receive care as per usual care. |
Usual Care |
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Expérimental: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Patient Power: Self-efficacy in Patient Physician Interactions
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Patient Knowledge
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Heather B. Neuman,, MD, MS, University of Wisconsin, Madison
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- A231701CD
- NCI-2018-00643 (Identificateur de registre: NCI Clinical Trial Reporting Program)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Délai de partage IPD
Beginning 6 to 12 months following article publication.
Critères d'accès au partage IPD
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
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