Cargando…

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)

BACKGROUND: Advances in precision medicine have given oncologists new evaluative tools to better individualize treatments for patients with curable breast cancer. These innovations have revealed a need to improve patient understanding of novel, often complex information related to breast cancer trea...

Descripción completa

Detalles Bibliográficos
Autores principales: Hawley, Sarah T., Kidwell, Kelley, Zahrieh, David, McCarthy, Anne, Wills, Rachel, Rankin, Aaron, Hofer, Timothy, Chow, Selina, Jagsi, Reshma, Neuman, Heather
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9817354/
https://www.ncbi.nlm.nih.gov/pubmed/36609349
http://dx.doi.org/10.1186/s13063-022-07048-4
_version_ 1784864736555302912
author Hawley, Sarah T.
Kidwell, Kelley
Zahrieh, David
McCarthy, Anne
Wills, Rachel
Rankin, Aaron
Hofer, Timothy
Chow, Selina
Jagsi, Reshma
Neuman, Heather
author_facet Hawley, Sarah T.
Kidwell, Kelley
Zahrieh, David
McCarthy, Anne
Wills, Rachel
Rankin, Aaron
Hofer, Timothy
Chow, Selina
Jagsi, Reshma
Neuman, Heather
author_sort Hawley, Sarah T.
collection PubMed
description BACKGROUND: Advances in precision medicine have given oncologists new evaluative tools to better individualize treatments for patients with curable breast cancer. These innovations have revealed a need to improve patient understanding of novel, often complex information related to breast cancer treatment decisions. Ensuring patients have the emotional support to face consequential treatment decisions, as well as the opportunity to engage and discuss with their clinicians, is key to improving patient-centered communication and patient understanding. METHODS/DESIGN: This study will implement a multilevel intervention with patient and clinician components as a NCORP Cancer Care Delivery Research (CCDR) trial within the Alliance for Clinical Trials in Oncology Research Base (Alliance). The two interventions in this study, the Shared Decision Engagement System (SharES), include (1) two versions of an evidence-based patient-facing breast cancer treatment decision tool (iCanDecide +/− an emotional support module) and (2) a clinician-facing dashboard (Clinician Dashboard) that is reviewed by surgeons/clinicians and summarizes ongoing patient needs. The design is a near minimax, hybrid stepped wedge trial of SharES where both interventions are being evaluated in a crossed design over six 12-week time periods. The primary outcome (knowledge) and key secondary outcomes (i.e., self-efficacy and cancer worry) are assessed via patient report at 5 weeks after surgery. Secondary outcomes are also assessed at 5 weeks after surgery, as well as in a second survey 9 months after registration. We anticipate recruiting a total of 700 breast cancer patients (600 evaluable after attrition) from 25 surgical practices affiliated with Alliance. DISCUSSION: Upon study completion, we will have better understanding of the impact of a multilevel intervention on patient-centered communication in breast cancer with a specific focus on whether the intervention components improve knowledge and self-efficacy and reduce cancer worry. TRIAL REGISTRATION: ClinicalTrials.govNCT04549571. Registered on 16 September 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-07048-4.
format Online
Article
Text
id pubmed-9817354
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-98173542023-01-07 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) Hawley, Sarah T. Kidwell, Kelley Zahrieh, David McCarthy, Anne Wills, Rachel Rankin, Aaron Hofer, Timothy Chow, Selina Jagsi, Reshma Neuman, Heather Trials Study Protocol BACKGROUND: Advances in precision medicine have given oncologists new evaluative tools to better individualize treatments for patients with curable breast cancer. These innovations have revealed a need to improve patient understanding of novel, often complex information related to breast cancer treatment decisions. Ensuring patients have the emotional support to face consequential treatment decisions, as well as the opportunity to engage and discuss with their clinicians, is key to improving patient-centered communication and patient understanding. METHODS/DESIGN: This study will implement a multilevel intervention with patient and clinician components as a NCORP Cancer Care Delivery Research (CCDR) trial within the Alliance for Clinical Trials in Oncology Research Base (Alliance). The two interventions in this study, the Shared Decision Engagement System (SharES), include (1) two versions of an evidence-based patient-facing breast cancer treatment decision tool (iCanDecide +/− an emotional support module) and (2) a clinician-facing dashboard (Clinician Dashboard) that is reviewed by surgeons/clinicians and summarizes ongoing patient needs. The design is a near minimax, hybrid stepped wedge trial of SharES where both interventions are being evaluated in a crossed design over six 12-week time periods. The primary outcome (knowledge) and key secondary outcomes (i.e., self-efficacy and cancer worry) are assessed via patient report at 5 weeks after surgery. Secondary outcomes are also assessed at 5 weeks after surgery, as well as in a second survey 9 months after registration. We anticipate recruiting a total of 700 breast cancer patients (600 evaluable after attrition) from 25 surgical practices affiliated with Alliance. DISCUSSION: Upon study completion, we will have better understanding of the impact of a multilevel intervention on patient-centered communication in breast cancer with a specific focus on whether the intervention components improve knowledge and self-efficacy and reduce cancer worry. TRIAL REGISTRATION: ClinicalTrials.govNCT04549571. Registered on 16 September 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-07048-4. BioMed Central 2023-01-06 /pmc/articles/PMC9817354/ /pubmed/36609349 http://dx.doi.org/10.1186/s13063-022-07048-4 Text en © This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Hawley, Sarah T.
Kidwell, Kelley
Zahrieh, David
McCarthy, Anne
Wills, Rachel
Rankin, Aaron
Hofer, Timothy
Chow, Selina
Jagsi, Reshma
Neuman, Heather
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)
title 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_short 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)
title_sort 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)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9817354/
https://www.ncbi.nlm.nih.gov/pubmed/36609349
http://dx.doi.org/10.1186/s13063-022-07048-4
work_keys_str_mv AT hawleysaraht improvingpatientcenteredcommunicationinbreastcancerastudyprotocolforamultilevelinterventionofasharedtreatmentdeliberationsystemshareswithinthencicommunityoncologyresearchprogramncorpalliancea231901cd
AT kidwellkelley improvingpatientcenteredcommunicationinbreastcancerastudyprotocolforamultilevelinterventionofasharedtreatmentdeliberationsystemshareswithinthencicommunityoncologyresearchprogramncorpalliancea231901cd
AT zahriehdavid improvingpatientcenteredcommunicationinbreastcancerastudyprotocolforamultilevelinterventionofasharedtreatmentdeliberationsystemshareswithinthencicommunityoncologyresearchprogramncorpalliancea231901cd
AT mccarthyanne improvingpatientcenteredcommunicationinbreastcancerastudyprotocolforamultilevelinterventionofasharedtreatmentdeliberationsystemshareswithinthencicommunityoncologyresearchprogramncorpalliancea231901cd
AT willsrachel improvingpatientcenteredcommunicationinbreastcancerastudyprotocolforamultilevelinterventionofasharedtreatmentdeliberationsystemshareswithinthencicommunityoncologyresearchprogramncorpalliancea231901cd
AT rankinaaron improvingpatientcenteredcommunicationinbreastcancerastudyprotocolforamultilevelinterventionofasharedtreatmentdeliberationsystemshareswithinthencicommunityoncologyresearchprogramncorpalliancea231901cd
AT hofertimothy improvingpatientcenteredcommunicationinbreastcancerastudyprotocolforamultilevelinterventionofasharedtreatmentdeliberationsystemshareswithinthencicommunityoncologyresearchprogramncorpalliancea231901cd
AT chowselina improvingpatientcenteredcommunicationinbreastcancerastudyprotocolforamultilevelinterventionofasharedtreatmentdeliberationsystemshareswithinthencicommunityoncologyresearchprogramncorpalliancea231901cd
AT jagsireshma improvingpatientcenteredcommunicationinbreastcancerastudyprotocolforamultilevelinterventionofasharedtreatmentdeliberationsystemshareswithinthencicommunityoncologyresearchprogramncorpalliancea231901cd
AT neumanheather improvingpatientcenteredcommunicationinbreastcancerastudyprotocolforamultilevelinterventionofasharedtreatmentdeliberationsystemshareswithinthencicommunityoncologyresearchprogramncorpalliancea231901cd