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Abstract

Background:

Breast cancer is the leading cause of cancer-related morbidity and mortality among Indian females, accounting for 13.5% of new cancer cases and 10.6% of all cancer deaths. The median 5-year survival rate was 73.8%, ranging from 93.3% for patients with stage I to only 24.5% for those with stage IV disease. A comprehensive package of effective interventions implemented with quality is expected to improve survival.

Objectives:

To develop and implement a package of interventions so that at least 80% of patients with breast cancer are provided with evidence-based quality care.

Design:

The proposed implementation research will follow a mixed-method approach executed at 13 sites in India.

Methods:

The study will be conducted in three phases. During the formative phase, facilitators and barriers in diagnostic evaluation and treatment delivery in patients with non-metastatic breast cancer will be identified using a mixed-method approach. Simultaneously, prospective baseline data collection with emphasis on selected key performance indicators (KPIs) will be done for 6 months. Results from the formative phase will be used to develop a healthcare model that will ensure evidence-based quality care for at least 80% of stage II breast cancer patients. In the implementation phase, a trial run of this health care package will be conducted, and periodic assessment of its smooth running will be ensured. Depending on the requirements of each site, two to three iterations will be done, and a final healthcare package will be fixed. This finalized model will be executed for 1 year. At the end of 1 year, selected KPIs will be reassessed. At the evaluation phase, the outcome of the model will be assessed by comparing KPIs. Even after completing this project, patients will be followed up regularly for tracking long-term outcomes.

Discussion:

Achieved targeted interventions will help to set up a clinical care pathway with early diagnosis, timeliness of providing treatment, reduced default and abandonment, and improved survival among breast cancer patients in India.

Keywords

health care providers implementation package key performance indicators patients stage II breast cancer

Introduction

Background

Cancer is a major health care problem worldwide. In females, breast cancer is the most common type of cancer globally. In 2022, 2.3 million women were diagnosed with breast cancer, accounting for 28.2% of all female cancers. The figures can be translated as an estimated 216,108 cases and 670,000 deaths globally.^1,2 According to the Global Cancer Observatory, 23.8% of all new cancer cases in females were breast cancer, with an annual incidence rate of 186.3/100,000 women. The age-standardized death rate is 76.9. In India, breast cancer is the leading cause of cancer-related mortality in females, with approximately 850,000 deaths in 2020.³ By 2025, the number of deaths from female breast cancer in India is estimated to reach 5.6 million disability-adjusted life years (DALYs).⁴ As per the Indian Council of Medical Research-National Centre of Disease Informatics and Research (ICMR-NCDIR) report in 2020, the age-adjusted standardized incidence rate of breast cancer in India ranges from 7 to 48 per 100,000 women, with the highest in the south (Telangana) and the lowest in the northeast (Meghalaya).⁵ A large multi-institutional study of 3500 non-metastatic breast cancer patients from private centers showed a 5-year survival rate of 90% across all tumor subtypes.⁶ The median age at which breast cancer is diagnosed in India is 52 years, which is about a decade ahead of many developed countries like the USA (62) or Europe (45–69).^7
–9 A very small number of women diagnosed with breast cancer in the USA are younger than 45, and vary in Europe from 45 to 69 (20% occur at age <50 years old, and 33% occur at age 50–64 and above).⁸ Breast cancer screening in India is considerably low (1.9%) compared to others, like 82% in the USA, 70% in the UK, and 23% in China.^10,11

Rationale and knowledge gap

The survival rate across the country varies; a study by Viral et al.,¹⁰ in a cohort of 1300 patients, showed a 5- and 10-year survival rate of 79% and 65%, respectively. The overall survival (OS) rate was 73.8%, with a higher survival rate of 93.3% for patients with stage I cancer and a lower survival rate of 24.5% for those with stage IV disease.^10
–12 In stage II, breast cancer’s 5-year survival rate is 66%–70% in India as compared to developed countries, which is 90%–99%. Moreover, about half of breast cancer patients in India get diagnosed between the ages of 25 and 50 years. With a low screening rate, we are underestimating the problem, and a younger age at diagnosis would mean a higher loss of DALYs attributable to the disease. Furthermore, poor survival and high mortality were observed in over 70% of patients who often present in an advanced stage of disease.^11,12 The poor rate of survival from breast cancer in India may be attributed to several factors, for example, delay in diagnosis, lack of quality care, and lack of awareness about breast cancer and available screening and treatment options among the general community. In India,^12,13 breast cancer is a curable disease, and early detection, diagnosis, and timely treatment increase the likelihood of survival. There is an urgent need to address low survival rates in breast cancer and saturate the country with good-quality care through the implementation of research studies on breast cancer survival. Gaps exist in the care continuum from stages of screening and diagnosis to delivering evidence-based, individualized care with an appropriate mix of surgery, radiotherapy, and chemotherapy. The heterogeneous nature of the Indian healthcare sector provides a unique opportunity to exchange ideas and learnings; a collective knowledge pool can be generated from experts working in different facilities and regions of this vast nation. Therefore, ICMR envisages a study under the National Health Research Priority Project (NHRP) to improve the survival rate among stage II breast cancer patients in India. It will be co-designed by participating centers with oversight from a group of technical experts to be implemented in all the study sites.

Objective

Primary objective

To develop and implement a package of interventions so that at least 80% of patients with breast cancer are provided with evidence-based quality care.

Secondary objectives

To identify the facilitators/enablers and barriers leading to diagnostic and treatment delays, suboptimal cancer care delivery, defaults, and abandonment in patients with breast cancer.

To assess the success of the cancer care model using the package of services based on selected key performance indicators (KPIs).

To estimate the disease-free and OS rates in patients with stage-II breast cancer.

Methods

Study design

This proposed implementation research will follow a mixed-method (qualitative and quantitative) approach executed at 13 sites across India.

Study duration

The proposed duration of the study will be 36 months, and the study will be divided into three phases.

Phase I: Formative research phase—qualitative and quantitative research for 6 months.

Phase II: Implementation or intervention phase—interventional single-arm pre- and post-study—24 months.

Phase III: Evaluation phase, 6 months.

Study population

All patients with non-metastatic breast cancer attending the hospital will be considered for the study.

Sampling method—consecutive sampling.

Inclusion criteria

(a) Age: More than 18 years.

(b) All patients who will be registered in the hospital for treatment.

Every patient will be screened for eligibility using the following disease-specific criteria:

(i) Eastern Cooperative Oncology Group score with score 0–4.

(ii) Clinical staging based on “TNM.”

(iii) Pathological staging after postoperative histopathology report of the patients.

(iv) Any chief complaints like lump, nipple retraction, pain, nipple discharge, or ulcer on the breast.

(v) Tumor size ranges between 0 and 27 cm.

(d) Any history of cancer and previous disease.

Exclusion criteria

The patients diagnosed and confirmed for breast cancer at the study site’s hospital but start getting treatment outside hospitals/institutions other than the study site will not be considered to be included in the study.

Sample size calculation

Each center’s annual load of breast cancer patients of all stages is assumed to be N, and the proportion of stage II patients is considered as “p.” Then, each center is assumed to examine Np = N' stage II patients in a year. The sample size required to obtain 80% adherence to the standard of care at a 95% level of significance and a margin of error =d is estimated by the formula:

\begin{array}{l} E s t i m a t e d N = N ’ z 1 - α / 220.81 - 0.8 d 2 N ’ - 1 + \\ N ’ z 1 - α / 220.81 - 0.8 \end{array}

\begin{array}{l} Assuming a 15 % dropout, the \\ actual sample size = N / (1 - 0.15) . \end{array}

Based on the above formula, the sample size of Stage II breast cancer patients to be recruited in the study from each hospital is as follows.

For centers with an annual load of 1000 breast cancer patients, 30% of them being in Stage II, the minimum sample size assuming a dropout rate of 15% is 160. For centers with an annual load of 400 patients, the sample size is 95.

The calculated sample size is to assess the feasibility. The Institutional Ethics Committee of all 13 sites approved the current study (Supplemental Material 1). Informed consent will be obtained from all participants of the 13 sites involved in the study. All consecutive patients attending the health facility during the study period will be included. SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Guidelines¹⁴ will be followed for our study.

Phases of the study

Study phase I—Formative phase

The formative phase spans 6 months, encompassing preparatory activities. It is intended to collect qualitative and quantitative information pertaining to project objectives and identify bottlenecks where interventions will be critical. We will adopt a collaborative approach through group discussions, in-depth interviews (IDIs), and workshops. The diverse group of stakeholders will capture a wide array of barriers and facilitators for the successful implementation of the study across the country. The sequence of activities involves:

1. Development and planning.

This includes the preparatory activities and mapping of the stakeholders, and this step focuses on understanding the gaps through stakeholder mapping and situational analysis. This phase also includes the identification of barriers and facilitators at the level of all stakeholders and identifying the factors responsible for facilitating and hindering the implementation package, and constitutes the different monitoring teams for the study.

2. Mapping the stakeholders.

Stakeholders can be defined as individuals or groups who are responsible for or affected by health and health-related decisions that can affect the implementation of research.

(i) Health care providers (HCP): Healthcare providers from various departments would be included. The team of HCP consists of surgical oncologists, medical oncologists, radiation oncologists, psycho-oncologists, nurses, and social workers across all 13 sites and will be considered as a core multi-disciplinary team (MDT) for respective sites.

(ii) Caregivers

A caregiver in this study is defined as a person involved in the process of care from breast cancer diagnosis until the treatment’s completion and spends the most time with the patient, both at the hospital and at home.

(iii) Patient

In the proposed study, patients can be defined as those who are newly diagnosed and awaiting breast cancer treatment, and those who are on treatment (surgery/chemotherapy, and radiation therapy). Breast cancer survivors are those who have completed at least 1 year of treatment. Patients abandoned or defaulted from treatment are defined as those patients who left the treatment or treatment delay, that is, at least 6 months’ gap in treatment and follow-up or left the treatment and chose another modality of treatment.

Qualitative research

Qualitative research is a part of the formative phase, which is a key step in identifying the barriers and facilitators faced by stakeholders at different levels. This qualitative research part will be an important tool that can explore and understand what the individuals or groups ascribe to a problem in the context of the diagnosis and treatment of breast cancer.

Approaches used in qualitative research:

a. IDIs

b. Focus group discussions (FGDs).

In-depth interviews

IDIs will be carried out in each site with 25 participants, comprising patients with breast cancer, their caregivers, and healthcare professionals. The purpose of IDIs is to elucidate detailed information on data collection from breast cancer patients, their caregivers, and healthcare professionals’ perspectives, experiences, and feelings about a diagnosis or late diagnosis, healthcare services, and treatment or delay in treatment of breast cancer in the country. In our study, interview questions will be primarily open-ended and lead to an exploration-oriented approach in the context of breast cancer diagnosis and treatment. It usually begins with more general questions and gradually incorporates more complex and sensitive subjects. In this study, each site will carry out IDIs for nine patients, eight caregivers, and eight healthcare professionals using the semi-structured interview guides developed and validated by experts. The IDIs will be conducted by a trained researcher in the regional language, translated into English, and then used for analysis.

Focus-group discussions

Data will be collected using FGDs, in which a selected group of patients, caregivers, and healthcare professionals will discuss breast cancer diagnosis and its treatment in-depth, facilitated by a professional, external moderator.¹⁵ This method serves to understand participants’ attitudes and perceptions, knowledge and experiences, and practices, shared in the course of interaction with different people of the respective group. The technique is based on the assumption that the FGD helps to identify and clarify shared knowledge among homogeneous groups and communities, which would otherwise be difficult to obtain with a series of individual interviews. Also, an FGD allows the investigator to solicit both the participants’ shared opinions/experiences as well as their differences.

In this study, to obtain collectivistic views of the healthcare professionals, caregivers, and patients on the facilitators and barriers in offering quality care to breast cancer patients and their treatment, three FGDs at each site with 8–10 participants will be conducted. One FGD each among breast cancer patients, caregivers, and healthcare professionals will be conducted. Similar to IDIs, the FGD discussion will also be conducted by trained researchers using a semi-structured interview guide. All the recorded interviews will be transcribed within 24 h. If the interview/transcript is in a regional language, it will be translated into English. The transcript will be entered in an Excel sheet in the specific format and will be analyzed.

Quantitative research

The quantitative data collection will be carried out by the identification of KPIs and filling up the patient’s information through the Case Report Form (CRF).

Key performance indicators

The Delphi method will be used to identify the KPIs of breast cancer. This offers a structured form of data collection for in-depth analysis by combining expert members of the MDT opinions using a series of iterative questionnaires. Initially, 50 performance indicators will be selected by the MDT team. The performance indicators will be chosen based on the screening, diagnosis, treatment, and follow-up of breast cancer. The key indicators will be finalized to capture the data on “Investigation-pathology/radiation surgery” (pre and post-operative histopathology which records pathological stage, BIRADS, size of the invasive component, biopsy, pCR, and Margin status), “surgery” (breast conservation surgery, mastectomy, MRM), “systemic therapy” (adjuvant chemotherapy/neoadjuvant chemotherapy, hormone therapy), and “psycho-social” (distress evaluation and management and counseled for fertility preservation) levels for developing and implementing a health care model to improve the survival of breast cancer patients. Additionally, patients who could not adhere to the treatment plan after diagnosis/surgery/chemotherapy/radiation therapy will also be captured. The KPI will be appropriately defined with a numerator and denominator and will define the minimum achievable target for each index that is acceptable. 150–200 KPI will be identified by the literature search. The expert team will reduce the number of KPIs to 50. The finalized KPIs will be decided by Delphi process with two rounds of discussion and voting with expert members of the MDT team.

Case report form

A CRF will be designed to collect the patient’s data based on the selected KPI. Its development represents a critical milestone in our national health research priority study. It will influence quality outcomes. Site personnel will capture the patient’s data in the CRF. The primary objective of CRF design is to gather complete and accurate data from each patient at baseline across the study sites. Structured proforma will be designed to obtain patient data that includes their socio-demographic, personal history, clinical examination, final diagnosis, pathological examination, treatment depending upon the subtype of breast cancer (hormone positive Her2 negative, hormone negative Her2 negative, hormone positive Her2 positive, triple-negative breast cancer), and other patient-related information. All these data will be captured in an electronic CRF (e-CRF) on the REDCap portal, which consists of the following sections: at the time of.

Structure of e-CRF, including the following major headings:

Demography

Clinical examination/personal history

Investigation (pathology, imaging, and biopsy)

Final diagnosis

Surgical oncology

Radiation

Medical oncology

Follow-up.

The quantitative baseline data will be captured with special emphasis on KPIs from all 13 study sites included in this breast cancer survival study through REDcap. All 13 sites will be submitting their patients’ data electronically in a structured e-CRF. Prospective baseline data collection will be done for all stage I, stage II, and stage III breast cancer patients for 6 months.

Data analysis of the formative phase

Data collection will be carried out by an MDT based on qualitative and quantitative research. The analysis will be guided by the Consolidated Framework for Implementation Research (CFIR) framework, categorizing implementation predictors into five domains, each with constructs and sub-constructs. The dedicated 1-month period for data analysis using NVivo software version 15 and reporting ensures focused and timely documentation of baseline findings. At the end of the formative research phase, we will be able to identify the facilitators/enablers and barriers of diagnostic and treatment delays, suboptimal cancer care delivery, defaults, and abandonment. Baseline data from the IDIs, FGD, and e-CRF at the level of patients, caregivers, and health professionals will also be a part of the formative research. These data will be useful in developing the health care model in patients with stage-II breast cancer as an implementation package across the country.

Study phase II: Implementation phase

The implementation phase is intended to ensure a comprehensive and adaptable approach to focus on engagement, adaptability, and encouragement of all stakeholders for the implementation package.^16
–18 The proposed implementation research will be the first in India to design and implement an effective healthcare model for patients to improve the survival of breast cancer patients. The implementation phase will be 24 months, with the recruitment of stage-II breast cancer patients and collecting the data to implement the healthcare model in patients with stage-II breast cancer at 13 sites across India. This study targets the modifiable factors for poor survival, diagnostic and treatment delays, and suboptimal cancer care delivery using an effective strategy based on the baseline data collection and information from formative phases across the 13 sites. In this phase, KPIs will also be evaluated and modified depending on the requirements of sites, and also assess the modified KPIs in implementing the breast cancer healthcare model as an implementation package across India. Furthermore, upon implementing the health care model, two–three iterations will be done in the implementation package depending upon KPI and 6-monthly evaluations of the program. During the iterative phase, it will be possible to continuously enhance and align with the evolving requirements for the uniform protocol for the management of stage-II breast cancer patients and the context of the selected 13 study sites.

Intervention details

We will develop implementation packages that can include mandatory and optional elements and weightage for each intervention component, which will be given and mentioned in Table 1.

Table 1.

Approaches for intervention planning, tools, and their outcome measurement.

Serial number	Intervention	Tools to be used	Outcome measurement (KPI)
1.	Constituting a dedicated breast cancer group for coordination from diagnosis to treatment plan as a multi-disciplinary group.	Registry software for data collection Virtual tumor board Standard operating guidelines SMART criteria for selecting KPI	Time to initiate treatment (diagnosis to start of treatment). Patients undergoing diagnostic biopsy. Undergoing appropriate staging investigation (Mammogram/Staging investigation). Patients with ER/PR/Her2neu report Patients discussed in multi-disciplinary tumor board.
2.	Optimizing treatment protocols and delivery within acceptable timelines	Standard operating guidelines Patient satisfaction survey	Patients undergoing planned treatment as discussed in the MDT. Time to initiate various treatment modalities. Positive margins. Re-excision rates. Completeness of pathology reporting. Adequate node sampling rate. Duration of hospital stay post-surgery. Treatment morbidity and mortality—30-day post op mortality, chemotherapy, and radiotherapy. Grade 3 lymphedema.
3.	Psychosocial intervention to prevent default	Psychoeducation and treatment rationale (printed material, videos, mobile applications) Digital app Social support and peer support group	Dropout rate. Treatment completion rate. Adherence to treatment plan. Appointment attendance rate. Patient satisfaction and engagement.
4.	Teleconsultation program for follow-up	Develop standard operating guidelines capacity building and training video conference platform and telemedicine application	Patients undertaking teleconsultation. Adherence to teleconsultation. Identification of relapse and recurrence. Completing 2 years of the teleconsultation process.
5.	Late effect clinic	Survivorship care planning Screening of late effects Rehabilitation program (lymphoedema and breast cancer-related questionnaire)	Late effect identification rate. Improvement in functional outcomes using HRQoL.

KPI, key performance indicators; MDT, multi-disciplinary team; QoL, quality of life.

Implementation component

The implementation component is a structured approach to implementing evidence-based intervention and implementation strategies. Four components form part of a deliberate and structured approach to implementation: stage approach, addressing enablers and barriers, using implementation strategies, and monitoring implementation outcomes.^16,19

Implementation is viewed as a process that occurs in distinct, often overlapping stages: explore, prepare, deliver, and sustain. These stages will help in developing a plan and executing implementation efforts more effectively. In our proposed study, we will use implementation strategy approaches for developing the health care model for stage-II cancer patients (Figure 1 and Table 1). This includes multiple meetings to arrive at a standardized clinical care pathway and finalizing KPIs for assessing quality care (Figure 1). A core MDT will be created at all centers with the standard operating procedure (SOP) for conducting virtual tumor boards for all cases and developing material for psychosocial education, SOPs for surgery, radiation, follow-up, and peer support groups across the centers.

Figure 1.

Adapted CFIR as per the intervention package for the breast cancer clinical care model.

Comprehensive implementation package

This research protocol will apply rigorous methods and concepts described in the CFIR to understand and address the contextual determinants (breast cancer treatment) and develop practical strategies for the successful implementation of the breast cancer healthcare model.^14,15 The CFIR framework is a “meta-theoretical” framework derived from evidence-based constructs from existing implementation theories and reports. It helps in identifying multi-level constructs (potential factors) that influence the intervention implementation and effectiveness.

The proposed implementation study is based on the CFIR framework to improve the survival rate of breast cancer patients. The developed breast cancer clinical care pathway will be shared across the centers (Figure 2). Strengths, weaknesses, opportunities, and threats analysis will be done to arrive at critical requirements. The core team will hold multiple rounds of discussions with other centers to identify roadblocks and will work out ways around them. Assigning and training roles for navigators/coordinators will be done. Setting up infrastructure and training for teleconsultation for follow-up is also planned.

Figure 2.

Study site locations across India (13 sites).

Follow-up of the patients will give information about adherence to the treatment protocol. Follow-up of the patient will be recorded through REDCap (e-CRF) data entry for the first 2 years and 6 months. During this period, assessment for lymphedema by clinical examination and annual mammogram will be done. And the quality check of the data will be done. During follow-up, quality of life (QoL) assessment, thyroid function tests, and lymphedema measurement will be done at 6 months; QoL, lymphedema assessment, DEXA scan, clinical examination, and annual mammogram will be done at 1 year.

Monitoring implementation outcomes

Data management team

The team will check the data weekly, and a report will be given to all 13 sites. The status of the data will be updated monthly. The quality check of the data by the team and site will be conducted once in 6 months. 3% of the data will be cross-checked at the site, and 3% of the data will be quality-checked with the resource data/file. Furthermore, 5% of the data will be checked with raw data along with the e-CRF.

Monitoring team

The monitoring field visit will be conducted by a monitoring team at all 13 sites once in 6 months.

Training team

Monthly training will be given at all 13 sites once in 6 months, and once in 3 months, training will be conducted after every completion of 6 months.

Technical advisory group

The technical advisory group team will review the 6-month interim report, and the annual report will also be reviewed and recommended for the continuation of the study.

Implementation team

The implementation team will be formulated, which consists of psycho-oncologists, epidemiologists, surgical oncologists, radiation oncologists, and social workers. Training will be given at all 13 sites about the implementation package and implementation strategy. Monitoring will be conducted by a team at each site. Required troubleshooting will be done wherever required. After the implementation package, a 6-month review will be conducted. The iteration will be made as per the requirements of each site. An evaluation will be conducted, and a scale-up of the proposal will be done.

Phase III: Evaluation phase

To assess the implementation outcomes measures, we will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework (Table 2).^17,20 In this phase, an assessment of the quantum of success in achieving objectives will be done by comparing it to the baseline KPI. The sustainability and adaptability of the program will be evaluated.

Table 2.

REAIM framework-based outcome measures of study.

Dimensions	Activities in clinical setting	Outcome parameters
Reach	All patients with breast cancer (stages I, II, III) attending the hospital.	At least 80% of breast cancer patients of 13 study sites across India.
Effectiveness	The impact of breast cancer clinical care model as intervention outcomes based on baseline data collection with special emphasis on KPI using retrospective data. Assess the facilitators and barriers leading to diagnostic and treatment delays, suboptimal cancer care delivery, defaults, and abandonment in breast cancer patients.	Success of the cancer care model using interventions on improving indicators (KPI) by 50% over the baseline. Improvement in QoL and DFS and OS of stage-II breast cancer patients.
Adoption	This new intervention package may be adopted at the level of healthcare providers, caregivers, and patients.	Capacity building and providing training for patient navigators, counselors, and teleconsultation. Adoption of intervention package by 80% caregivers, patients, and 90% healthcare providers at all study sites.
Implementation	Fidelity and adherence of the breast cancer clinical care model as standard treatment implementation package.	Acceptability of clinical care intervention package by patients, caregiver, and HCPs at all study sites to improve quality of care in stage-II breast cancer patients. Follow up for 80% adherence to clinical care treatment model at 1 year from diagnosis.
Maintenance	Sustainment of breast cancer clinical care model at all study sites and followed this model by other cancer sites across India.	Intervention becomes a standard of care treatment for stage-II cancer patients with the support of clinical HCPs.

DFS, disease-free survival; HCP, health care provider; OS, overall survival; QoL, quality of life; REAIM, Reach, Effectiveness, Adoption, Implementation, and Maintenance.

Statistical analysis

Descriptive statistics will be used for demographic and disease characteristics. Continuous variables will be depicted as means and standard deviations, and categorical variables as frequencies and percentages. Differences in baseline and post-intervention KPIs will be measured using t tests. Survival will be estimated using the Kaplan-Meier method, and factors affecting survival will be studied using the Cox proportional hazard model. Statistical analyses will be conducted using SPSS software (Version 20.0; IBM SPSS Statistics, Armonk, NY, USA) with a level of significance of less than 0.05.

Discussion

The proposed NHRP study addresses gaps in the diagnosis, treatment, and follow-up of breast cancer patients. The comprehensive care package, iterative process of refining the implementation model, and inbuilt mechanism of quality control will be pivotal in improving breast cancer survival across India. In India, there is a lack of uniformity in treatment protocol, and information concerning the effective strategy for developing the health care model for breast cancer patients is also insufficient.⁷ The project will go a long way in bridging the gaps. The number of newly diagnosed breast cancer cases is increasing every year. As a result, the burden on the healthcare system is also increasing, which may inevitably lead to treatment delays. This study will generate evidence to strengthen the healthcare model for stage II breast cancer patients. Studies conducted over the past 20 years have evaluated the delays experienced by breast cancer patients as well as their caregivers; yet, it is crucial to have a comprehensive, contextual understanding of the reasons behind the delays in our country.^{14,15,20
–23} Every healthcare system should have the capacity to assess and appropriately work up promptly.

Setting benchmarks for time to treatment completion using a predefined clinical care pathway is one of the key indicators. A single window approach may provide all basic treatment facilities under one roof, within the specified period, preventing unnecessary delays.¹⁵ Additional efforts are required to increase public awareness for early screening of breast cancer across the country. In addition, appropriate breast cancer screening programs, including the number of women screened, screening rates, detection methods used, recommended screening intervals, age groups covered, and methods for recruitment with diagnostic follow-up that need to be followed across the country. Ensuring a multidisciplinary approach to decision-making and care delivery, emphasizing a documented and audited process at each center for early diagnostic workup, comprehensive management policy, and minimizing treatment delays.²² Patients with cancer may benefit from MDT, which allows doctors from different areas to collaborate on treatment planning. Multidisciplinary clinics, like breast units, can be used for MDT.²⁰ Psychosocial support can be used as a strategy to prevent treatment refusal, non-adherence, and abandonment. A teleconsultation follow-up strategy and a late effect clinic are necessary to prevent long-term morbidity and mortality.^22,23 In addition, this research proposal has the potential to provide insights to improve the OS of breast cancer patients and healthcare services for breast cancer treatment that can be transferred to a large scale across the country’s contexts. The outcomes of this study will bring into focus the healthcare model of stage-II breast cancer patients’ care that may not be identified otherwise, including models that take into consideration shared decision-making and social determinants of health. While this participatory research project will consider the perceptions, experiences, expectations, and insights of different levels of stakeholders (healthcare providers, caregivers, and patients) in a collaborative and inclusive approach, an important challenge to data collection will be ensuring that all participants have the time to contribute to the consensus workshops.

Expected outcome

The primary outcome of the study is the acceptability of a clinical care intervention package to improve the quality of care in stage-II breast cancer. We expect 80% adherence to the health care treatment protocol at 1 year from diagnosis. In our study, adherence is defined as patients who have received at least 80% of the targeted interventions. This intervention led to positive deviance of KPIs, DFS, and OS of breast cancer patients. The targeted interventions will help to set up a clinical care pathway and reduce default and abandonment. The project will provide manpower training for patient navigators, counselors, and teleconsultation. Continuous monitoring and follow-up of patients will be integrated into the project’s future to track long-term outcomes, gather real-world evidence, and refine treatment protocols for improved patient care. If the model can achieve the objectives, the same care model can be used for all stages of breast cancer and even other cancer sites.

Data storage plan

The development of REDCap for data capture will be planned for the study. Each center is responsible for implementing data security of the clinical data collected using a paper-based or e-CRF, with a provision to be shared with ICMR. De-identified patient data, after removal of identifiers like name, address, and phone number, will be shared.

Limitations and challenges

The study involves the complexity of health systems’ stakeholders, policies, and protocols. Implementing new interventions in such systems can be challenging due to resistance to change, bureaucratic hurdles, and fragmented care. Factors such as cultural differences, socioeconomic variations, and geographic disparities can impact the effectiveness of interventions across different populations. There has to be a substantial time of implementation, after which an assessment should be done to see the sustainability of the processes. Sustaining improvements in breast cancer care over time may require ongoing monitoring, adaptation, and reinforcement. Factors beyond the control of the implementation research team, such as changes in policies, regulations, or healthcare reimbursement, can influence the success of implementation efforts.

Supplemental Material

sj-docx-1-tam-10.1177_17588359251372832 – Supplemental material for A protocol paper on the implementation of health care model to improve the survival of breast cancer patients in India

Supplemental material, sj-docx-1-tam-10.1177_17588359251372832 for A protocol paper on the implementation of health care model to improve the survival of breast cancer patients in India by Biswajit Dubashi, Nisha K. Jose, Supriya Mallick, Budhi Singh, Ruchi Tripathi, Nandini Devi and Surendran Veeraiah in Therapeutic Advances in Medical Oncology

Footnotes

Acknowledgements

We thank Dr Arub Chakravarty, Professor, Department of Community Medicine, and Dean, Govt. Medical College, Kolkata, Dr Caleb Harris, Additional Professor and Head, Surgical Oncology, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS), Shillong, Dr Gomathi Shankar, Additional Professor, Department of Surgery, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry, Dr Manjit Kaur, Additional Professor, All India Institute of Medical Sciences, Bathinda, Dr Pankaja Raghava, Professor and Head, Department of Community Medicine, All India Institute of Medical Sciences, Jodhpur, Dr Pooja Ramakant, Professor, Endocrine and Breast Surgery Department, King Georges Medical University, Lucknow, Dr. Rajesh Kumar Singh, Professor and Chief, State Cancer Institute, Indira Gandhi Institute of Medical Sciences, Patna, Bihar, Dr Satheesan B, Director, Malabar Cancer Centre, Kerala, Dr Sridevi V, Professor, Cancer Institute, WIA, Adyar, Dr Syed Nisar, Associate Professor, Department of Medical Oncology, Sher-i-Kashmir Institute of Medical Sciences, Srinagar (SKIMS), Dr Vinay Kumar, Additional Professor and Head Department of Surgical Oncology, All India Institute of Medical Sciences, Bhopal for their inputs in designing the protocol.

Declarations

ORCID iDs

Biswajit Dubashi

Nisha K. Jose

Supriya Mallick

Ruchi Tripathi

Nandini Devi

Supplemental material

Supplemental material for this article is available online.

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