TY - JOUR
T1 - Adapting and implementing breast cancer follow-up in primary care
T2 - protocol for a mixed methods hybrid type 1 effectiveness-implementation cluster randomized study
AU - Fadem, Sarah J.
AU - Crabtree, Benjamin F.
AU - O’Malley, Denalee M.
AU - Mikesell, Lisa
AU - Ferrante, Jeanne M.
AU - Toppmeyer, Deborah L.
AU - Ohman-Strickland, Pamela A.
AU - Hemler, Jennifer R.
AU - Howard, Jenna
AU - Bator, Alicja
AU - April-Sanders, Ayana
AU - Kurtzman, Rachel
AU - Hudson, Shawna V.
N1 - Publisher Copyright:
© 2023, The Author(s).
PY - 2023/12
Y1 - 2023/12
N2 - Background: Advances in detection and treatment for breast cancer have led to an increase in the number of individuals managing significant late and long-term treatment effects. Primary care has a role in caring for patients with a history of cancer, yet there is little guidance on how to effectively implement survivorship care evidence into primary care delivery. Methods: This protocol describes a multi-phase, mixed methods, stakeholder-driven research process that prioritizes actionable, evidence-based primary care improvements to enhance breast cancer survivorship care by integrating implementation and primary care transformation frameworks: the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework and the Practice Change Model (PCM). Informed by depth interviews and a four round Delphi panel with diverse stakeholders from primary care and oncology, we will implement and evaluate an iterative clinical intervention in a hybrid type 1 effectiveness-implementation cluster randomized design in twenty-six primary care practices. Multi-component implementation strategies will include facilitation, audit and feedback, and learning collaboratives. Ongoing data collection and analysis will be performed to optimize adoption of the intervention. The primary clinical outcome to test effectiveness is comprehensive breast cancer follow-up care. Implementation will be assessed using mixed methods to explore how organizational and contextual variables affect adoption, implementation, and early sustainability for provision of follow-up care, symptom, and risk management activities at six- and 12-months post implementation. Discussion: Study findings are poised to inform development of scalable, high impact intervention processes to enhance long-term follow-up care for patients with a history of breast cancer in primary care. If successful, next steps would include working with a national primary care practice-based research network to implement a national dissemination study. Actionable activities and processes identified could also be applied to development of organizational and care delivery interventions for follow-up care for other cancer sites. Trial registration: Registered with ClinicalTrials.gov on June 2, 2022: NCT05400941.
AB - Background: Advances in detection and treatment for breast cancer have led to an increase in the number of individuals managing significant late and long-term treatment effects. Primary care has a role in caring for patients with a history of cancer, yet there is little guidance on how to effectively implement survivorship care evidence into primary care delivery. Methods: This protocol describes a multi-phase, mixed methods, stakeholder-driven research process that prioritizes actionable, evidence-based primary care improvements to enhance breast cancer survivorship care by integrating implementation and primary care transformation frameworks: the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework and the Practice Change Model (PCM). Informed by depth interviews and a four round Delphi panel with diverse stakeholders from primary care and oncology, we will implement and evaluate an iterative clinical intervention in a hybrid type 1 effectiveness-implementation cluster randomized design in twenty-six primary care practices. Multi-component implementation strategies will include facilitation, audit and feedback, and learning collaboratives. Ongoing data collection and analysis will be performed to optimize adoption of the intervention. The primary clinical outcome to test effectiveness is comprehensive breast cancer follow-up care. Implementation will be assessed using mixed methods to explore how organizational and contextual variables affect adoption, implementation, and early sustainability for provision of follow-up care, symptom, and risk management activities at six- and 12-months post implementation. Discussion: Study findings are poised to inform development of scalable, high impact intervention processes to enhance long-term follow-up care for patients with a history of breast cancer in primary care. If successful, next steps would include working with a national primary care practice-based research network to implement a national dissemination study. Actionable activities and processes identified could also be applied to development of organizational and care delivery interventions for follow-up care for other cancer sites. Trial registration: Registered with ClinicalTrials.gov on June 2, 2022: NCT05400941.
KW - Breast cancer
KW - Cancer survivorship
KW - EPIS
KW - Implementation strategies
KW - Practice change model
KW - Primary care
UR - http://www.scopus.com/inward/record.url?scp=85176085160&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85176085160&partnerID=8YFLogxK
U2 - 10.1186/s12875-023-02186-3
DO - 10.1186/s12875-023-02186-3
M3 - Article
C2 - 37946132
AN - SCOPUS:85176085160
SN - 1471-2296
VL - 24
JO - BMC Primary Care
JF - BMC Primary Care
IS - 1
M1 - 235
ER -