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Case Report - (2022) Volume 10, Issue 11

Protocol for a community-engaged, stepped wedge randomized trial to eliminate inequalities in breast cancer treatment through a regional patient navigation collaborative, putting research into action

Robert Hack*
Strategic Visions in Healthcare LLC, New York, NY, United States of America
*Correspondence: Robert Hack, Strategic Visions in Healthcare LLC, New York, NY, United States of America, Email:

Received: 01-Nov-2022, Manuscript No. ipacr-22-13179; Editor assigned: 04-Nov-2022, Pre QC No. ipacr-22-13179; Reviewed: 14-Nov-2022, QC No. ipacr-22-13179; Revised: 21-Nov-2022, Manuscript No. ipacr-22-13179; Published: 28-Nov-2022, DOI: 10.36648/2254-6081- 10.11-156


Racial and socioeconomic disparities in carcinoma mortality persist. In Boston, MA, Black, Non-Hispanic girls and Medicaid-insured people area unit 2–3 times a lot of probably to possess delays in treatment compared to White or in private insured girls. Whereas evidence-based care coordination methods for reducing delays exist, they're not consistently enforced across attention settings. Translating analysis into observe (TRIP) utilizes community engaged analysis strategies to deal with carcinoma supply disparities. Four Massachusetts Clinical Associate in Nursingd change of location Science Institute (CTSI) hubs collaborated with the Beantown carcinoma Equity Coalition (The Coalition) to implement an evidencebased care coordination intervention for Beantown residents in danger for delays in carcinoma care. The Coalition used a community-driven method to outline the matter of supply disparities, determine the target population, and develop a rigorous pragmatic approach. we have a tendency to selected a cluster-randomized, stepped-wedge hybrid kind I effectiveness-implementation study style. The intervention implements 3 evidence-based strategies: patient navigation services, a shared patient written record to be used across educational medical centers, and a web-based social determinants of health platform to spot and address barriers to worry. Primary clinical outcomes embody time to initial treatment and receipt of guideline-concordant treatment, that area unit captured through electronic health records abstraction. We are going to use mixed strategies to gather the secondary implementation.

Keywords: Breast cancer; Cytoreductive surgery; peritoneal metastases mitomycin C; Hyperthermia; Radical appendectomy


Inequity in carcinoma mortality among Black, non-Hispanic girls compared to White girls may be a well-recognized challenge. In 2014, a national study examining race-specific carcinoma mortality rates within the fifty largest U.S. cities known will increase in Black: White disparities, mostly thanks to substantial enhancements in White rates [1]. Boston, Massachusetts had the fifth highest rate ratio; from 1990 to 1994 to 2005–2009, the Black: White carcinoma morbidity quantitative relation in Beantown exaggerated from zero.94 to 1.49. In response, a bunch of multi-sector stakeholders together with the Massachusetts Cancer written record, state and native health departments, community support organizations, and educational health centers in Beantown, wherever carcinoma patients receive care, convened to explore a community-driven response to those findings. This cluster fashioned the Beantown carcinoma Equity Coalition (the Coalition) with the express goal of mistreatment numerous neutral views to develop city-wide solutions for inequities in carcinoma outcomes [2].

Early work of the Coalition explored accessible information to spot modifiable targets for action. Native information for 2007– 2012 showed a Black: White morbidity quantitative relation of one.36, likewise as a Black: Hispanic morbidity quantitative relation of four.60 and a Black: Asian morbidity quantitative relation of five.28. From 2001 to 2012, this resulted in seventy four excess Black deaths among girls but sixty five years. more analyses found that compared with White, insured carcinoma patients in Beantown, Black, non-Hispanic girls, and people on health care were 2–3 times a lot of probably to possess delays in initiating treatment on the far side sixty days, a delay related to worse outcomes. throughout this point amount, Black girls in Beantown received diagnostic procedure screenings at a similar rates, had more or less Associate in Nursing equal probability of presenting with advanced unwellness (4–5%), and had a lower incidence of carcinoma than White girls. These findings area unit per a growing body of proof that addressing delays within the receipt of timely carcinoma treatment is one vital approach to achieving equity in cancer outcomes.

Evidence-based interventions that address barriers to timely cancer treatment in at-risk communities exist however aren't enforced consistently across health systems. The Coalition known 3 interventions most relevant to our community: 1) Patient Navigation [3,4]. This patient-centered care coordination model uses lay medical experts integrated into the attention team to scale back delays in cancer take care of those with social determinants of health Patient Registries. Clinical registries that span attention systems address health disparities by providing a method of chase in danger populations in want of care screening for Social Determinants of Health (SDOH). Systematic screening for SDOH that have an effect on access to worry has potential to spot patients in danger for non-adherence and improve outcomes by directional those to accessible resources that address their health-related social wants. Currently, we have a tendency to lack implementation methods that address the challenges in translating these findings from single clinics into public health methods (T3-T4 implementation translation). We have a tendency to gift here the strategies for Translating analysis into observe (TRIP), a community-engaged, cluster-randomized, stepped-wedge hybrid kind effectiveness-implementation study that aims to facilitate the transfer of this scientific proof into everyday observe to mitigate health disparities.

Our approach aims to surmount proverbial barriers to the implementation of promising evidence-based care coordination interventions by partnering four Clinical and change of location Science Institute (CTSI) hubs that possess the required change of location infrastructure with a full of life multi-stakeholder Coalition UN agency share a typical community health goal.

Our main hypothesis is that implementation of the TRIP intervention can cut back supply disparities in carcinoma, which this approach can be applicable to addressing disparities in alternative regions and health conditions. The TRIP study has 3 strategic aims correlate with the look, execution, and dissemination of the intervention.


This study may be a kind one hybrid clinical effectivenessimplementation trial that aims to enhance timely, quality carcinoma care among at-risk carcinoma patients through implementation of Associate in Nursing integrated, evidencebased patient navigation intervention. Our primary outcome of clinical effectiveness is going to be evaluated mistreatment information abstracted from Electronic Health Records (EHR). Our secondary outcome of intervention implementation uses mixed strategies to live intervention uptake in universe clinical settings.

We will use a prospective, stepped wedge cluster randomised style to review implementation of the evidence-based intervention across six taking part educational medical centers in Beantown. in an exceedingly stepped wedge style there's no organisation at the patient level, however taking part sites (medical centers) area unit randomised with relevance the temporal order at that they ‘step’ or cross over from the criterion to the intervention. As pictured in the pragmatic stepped wedge study style involves a serial roll-out of the intervention across the six taking part sites over three-month intervals or “steps” wherever crossover happens. Historical management information are going to be collected from every web site for a minimum of twenty one months and most of thirty six months before intervention rollout, reckoning on their allotted crossover. serial crossover to the intervention at taking part sites can occur each 3 months over a 15-month amount, followed by an extra twenty four months of full study intervention amount.

The six educational medical centers we've partnered with area unit letter Israel deacon eye, Beantown eye, Brigham and Women's William Cuthbert Faulkner Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital and Tufts eye. These six educational medical centers are known by information from the Massachusetts Cancer written record as sites that take care of over ninetieth of girls with carcinoma UN agency area unit in danger for poor outcomes in Beantown, together with Black or Hispanic, Non-English speaking, and/or don't have any insurance or public insurance. As summarized we have a tendency to estimate increase of 1100 study subjects, together with more or less 511 historical controls and 589 intervention subjects across the six sites.

Patient Navigation services following commonplace in operation procedures that area unit guided by the Principles of Care Management united with a network of navigators across the six health systems. This includes distinctive girls eligible for navigation services; distinctive barriers to initiating timely cancer care services, with a specific stress on social barriers; providing help to deal with these barriers through native and regional resources; and, finally, chase girls over time across the taking part clinical sites to confirm they complete their entire course of cancer care. a visit navigation protocol was designed by the study team to mirror evidence-based best practices for medicine navigation. The innovation here is that the integrated network of navigation across regional health [5,6].

A real time patient written record that's shared across the six health systems the written record was designed mistreatment the HIPAA compliant REDCap platform through collaboration with clinical suppliers, patient navigators, IP specialists, and consultants from the REDCap team at Altruist University. Navigators enter basic demographic data and track screening and referrals for social determinants of health (see three. below). Clinical data is unbroken to a minimum in an endeavor to scale back redundancy with the EHR and minimize double information entry. This navigator tool produces reports that range the navigator's caseload supported pre-determined markers of timely care (e.g. days since diagnosis) Associate in Nursingd directs them with an unjust list of patients with unfinished navigation wants. A number of these functions need manual manipulation of {the information the info the information} mistreatment SAS and uploading that data back to REDCap. The written record permits communication between navigators, specifically around patients receiving care in additional than one location or transferring care between establishments, to stop delays and gaps in care. Navigators will message one another directly through REDCap [7,8]. They will additionally write notes concerning appointments and treatment received staff also are ready to use the written record as an observance tool to trace navigator activity.

A systematic screening and referral system to spot and address SDOH wants. At baseline and three months navigators conduct a scientific screening for social wants across nine social domains including: housing insecurity, food insecurity, paying for basic utilities, family caregiving, legal, and transportation, paying for treatment, education, and employment. We are going to partner with aunty Bertha, a web-based social network platform, to develop a TRIP-specific screening and referral system to support navigators in connecting patients with accessible social services. The aunty Bertha platform is an internet network of thousands of verified work programs together with nonprofits and social care suppliers UN agency serve the Beantown communities. Navigators can work with patients {to determine to spot} the foremost pressing domains then identify accessible community services to deal with every domain. At every contact, the navigators check on the standing of referrals and assess whether or not a lady would love to receive extra referrals from similar or totally different domains [9,10].


The planned method of rolling out the integrated intervention begins with partnering with a clinical medicine champion at every web site to spot existing navigation employees and document baseline navigation progress. we have a tendency to conceive to use many evidence-based implementation methods to push intervention adoption into existing workflows including: neutral engagement, development of the same intervention protocol, unvaried coaching and technical help on evidencebased protocol, and continuous observance and feedback. Once a navigator has been selected because the TRIP study navigator and completed their needed trainings, they're ready to begin navigating patients beneath the TRIP protocol. Navigators can prospectively determine recently diagnosed carcinoma patients meeting eligibility needs and initiate the protocol. Key protocol activities embody systematic and longitudinal screening for the social determinants of health, use of a web-based platform to spot resources and initiate referrals to deal with social problems that may interfere with cancer care, and use of a shared patient written record to speak with navigators from alternative taking part study sites within the event a study subject transfers care throughout the intervention amount.


I would like to thank my professor for his support and encouragement.

Conflict of Interest

The authors declare that there is no conflict of interest.


  1. Bijou R H, Steve W, Marc S H (2014) Increasing Black:White disparities in breast cancer mortality in the 50 largest cities in the United States. Cancer Epidemiol 38: 118-123.
  2. Pubmed, Google Scholar, Crossref

  3. John M M, Roger T A, Amy K F, Eric E S, Rajesh B et al. (2012) Effect on survival of longer intervals between confirmed diagnosis and treatment initiation among low-income women with breast cancer. J Clin Oncol 30: 4493-4500.
  4. Pubmed, Google Scholar, Crossref

  5. Omar A R (2018) Impact of timeliness of adjuvant chemotherapy and radiotherapy on the outcomes of breast cancer; a pooled analysis of three clinical trials. Breast 38: 175-180.
  6. Pubmed, Google Scholar, Crossref

  7. Richard J B, Karen R, Elin R S, Robert B, Eric R et al. (2016) Time to Surgery and Breast Cancer Survival in the United States. JAMA Oncol 2: 330-339.
  8. Pubmed, Google Scholar, Crossref

  9. Mariana C, Christina A C, Daphne Y L, Sharon H G (2016) Delayed Initiation of Adjuvant Chemotherapy Among Patients With Breast Cancer. JAMA Oncol 2: 322-329.
  10. Pubmed, Google Scholar, Crossref

  11. Jinghui D, Kimberly S E, Lauren B, Sabrina A K Mingqian L (2020) Timeliness of Treatment Initiation in Newly Diagnosed Patients With Breast Cancer. Clin Breast Cancer
  12. Pubmed, Google Scholar, Crossref

  13. Jenny J L, Natalia E, Rebeca F, Nina A B (2019) Breast Cancer: Does Type of Hospital Where You Get Surgery Affect Survival. J Healthc Qual 41: 49-58.
  14. Pubmed, Google Scholar, Crossref

  15. Mariana C, Christina A C, Daphne Y L, Sharon H G (2016) Delayed Initiation of Adjuvant Chemotherapy Among Patients With Breast Cancer. JAMA Oncol 2: 322-329.
  16. Pubmed, Google Scholar, Crossref

  17. Elizabeth A M, Steven M A, John A, Joan K, Jennifer H et al. (2003) The quality of health care delivered to adults in the United States. N Engl J Med 348: 2635-2645.
  18. Pubmed, Google Scholar, Crossref

  19. Tracy A B, Sharon M B, Timothy H, Clara A C, Richard K et al. (2012) Boston Patient Navigation Research Program: the impact of navigation on time to diagnostic resolution after abnormal cancer screening. Cancer Epidemiol Biomark Prev 21: 1645-1654.
  20. Pubmed, Google Scholar, Crossref

Citation: Hack R (2022) Protocol for a Community-Engaged, Stepped Wedge Randomized Trial to Eliminate Inequalities in Breast Cancer Treatment Through a Regional Patient Navigation Collaborative, Putting Research into Action. Archives Can Res, Vol.10 No. 11: 156.