Association of caregiver’s burden and mental health status in caregivers of patients with cancer from central rural India: a mixed-method study protocol

Abstract

Introduction

Cancer remains a growing public health challenge in India, impacting not only patients but also their caregivers, often family members who bear the emotional, physical and financial burdens of care. These family caregivers face overwhelming stress, anxiety and depression, particularly in rural areas with limited healthcare access. Cultural expectations often lead them to neglect their own well-being. Many are forced to reduce work or quit jobs, worsening financial strain. Despite their vital role, caregivers are largely overlooked in cancer care discourse. There is an urgent need for India-specific, empathetic research and policies that support caregiver health and recognise caregiving as a public health priority.

Methods and analysis

This study employs a sequential explanatory mixed-methods design to examine the association between caregiver burden and mental health status among informal caregivers of patients with cancer in central rural India. In the quantitative phase, a cross-sectional survey will be conducted using systematic random sampling. Data will be collected via a semistructured questionnaire and standardised tools: the Copenhagen Burnout Inventory to assess burnout levels, and the Depression, Anxiety and Stress Scale-21 to evaluate psychological distress. Statistical analysis will include descriptive statistics and regression analysis.

The qualitative phase will involve in-depth interviews with purposively selected caregivers to explore lived experiences, coping mechanisms and emotional challenges. Interviews will be transcribed and analysed using thematic content analysis. Integration of quantitative and qualitative findings will provide a comprehensive understanding of caregiver burden and mental health, reflecting both measurable patterns and the human experience of caregiving in a rural setting.

Ethics and dissemination

Ethical clearance for this study protocol was obtained from the Institutional Ethics Committee of Datta Meghe Institute of Medical Education and Research, Sawangi (Meghe), Wardha (Approval No. DMIHER(DU)/IEC/2025/436). Permission for data collection was further granted by both the institutional ethics committee and Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha. The findings of this research will be disseminated through publications in peer-reviewed scientific journals and by engaging relevant stakeholders through appropriate channels of communication.

Trial registration number

CTRI/2025/08/093357.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• Using quantitative tools followed by qualitative in-depth interviews provides a more comprehensive understanding of caregiver burden and improves validity through triangulation.

• Systematic random sampling increases representativeness of caregivers attending the oncology centre and minimises sampling bias.

• Use of Braun and Clarke’s objective method and two independent coders increases credibility, dependability and analytical rigour of qualitative findings.

• Self-reported measures of stress, anxiety and financial burden may lead to underreporting due to social desirability or cultural norms.

Introduction

Cancer is emerging as one of India’s most urgent public health challenges. Recent projections estimate India will record over 1.5 million new cancer cases annually, with rural communities shouldering a significant fraction.¹ It is due to the rising exposure to non-communicable disease (NCD) risk factors, delayed diagnoses and inadequate access to oncology services.² Rural regions often struggle with diagnostic delays, interrupted treatment continuity and sparse supportive care provisions, increasing both patient and caregiver distress.

In India, particularly in the rural areas, informal caregiving is provided primarily by family members without remuneration. This role imposes substantial emotional, physical, social and financial burdens. Emotional stress may include chronic anxiety, depression and anticipatory fear of cancer recurrence, while physical health often suffers through sleep deprivation, fatigue or pain.³ Social isolation, role confinement and disruption to daily routines are common. Financially, family caregivers frequently experience income reduction or out-of-pocket expenditures, particularly in settings lacking robust insurance or state-sponsored aid.⁴

Several Indian and international studies highlight the prevalence and determinants of family caregiver distress. A study from Mumbai involving family caregivers of older patients with cancer (≥ 60 years) found that while 76% reported little burden, nearly 20% experienced mild-to-moderate burden and burden was significantly higher when either the patient or the family caregiver had psychological issues or lower educational status.² A cross-sectional study of oral cancer family caregivers in central India reported 65% with depressive symptoms, 69% with anxiety and 75% with perceived stress, with predictors including lower income, advanced disease stage and limited education.⁵ A systematic review and meta-analysis (30 studies, n≈21 000 caregivers) reported pooled prevalence estimates of 42% for depression and 47% for anxiety, with key risk factors being financial strain, longer caregiving duration, female sex, lower education and poor caregiver sleep.⁶ A sub-Himalayan centre study found that caregiver quality of life deteriorated significantly with more advanced patient functional impairment (Eastern Cooperative Oncology Group score), longer chemotherapy cycles and being of lower socioeconomic status.⁴ International findings note that increased caregiving hours, poorer patient functional status, female gender, younger caregiver age and prolonged duty correlate with higher burden and elevated depression and anxiety scores.⁷

Rural India’s caregiving environment is shaped by cultural norms and structural constraints. Family caregiving is culturally ingrained, often defined as a familial obligation, reinforcing gender roles that place caregiving primarily on women, limiting social support and minimising caregiver self-care.⁸ Financial toxicity attributable to cancer is particularly acute in India due to heavy out-of-pocket healthcare expenses, low insurance penetration and inadequate public health spending. Family caregivers often absorb indirect costs, lost wages and medical expenditures, precipitating debt, poverty and mental stress.³ Accessibility gaps in rural mental health, such as minimal psychiatric workforce, lack of psychosocial support services and low awareness. These leave family caregiver’s psychological needs largely unaddressed.

To explore the coping mechanisms employed by family caregivers and identify the existing support gaps in the caregiving process for patients with cancer is very important. A mixed-method investigation in South India, 39 informal/family caregivers of patients with breast cancer were identified with key emotionally encumbered burden themes including emotional culpability, financial/work liability, psychosocial strain, physical exhaustion and inadequate health system responsiveness.⁸ Another study, which was a global cross-sectional survey of family caregivers, found that most caregivers tend to rely on emotion-focused coping strategies. These included holding on to hope, turning to religious faith and passively accepting the situation. In contrast, coping strategies that involved actively addressing the problem, like direct communication or taking purposeful action, were used less frequently.⁹

While quantitative approaches using burnout inventories and psychological assessment tools offer essential measurement precision, they often fail to capture the family caregiver’s narratives like their emotional landscapes, stigma, spiritual beliefs, coping strategies or unmet needs. Therefore, integrating quantitative data with qualitative exploration will enable:

1. Prevalence estimation of caregiver burden and psychological distress.

2. Identification of predictors, like economic status, caregiving hours and patient functional impairment.

3. Insight into lived experiences, unmet needs and resilience strategies.

4. Contextualisation of rural-specific challenges and informing culturally tailored interventions.

In India, the burden of NCDs continues to rise. With better treatment outcomes and improved survival rates, patients are living longer. But this also means that family caregivers are required to provide support for extended periods. As a result, the mental health of family caregivers is becoming an issue of growing concern and urgency. Rural family caregivers face compounded risk due to infrastructural limitations and the cultural expectation of personal sacrifice.¹⁰ Despite their critical role, family caregiver experiences in rural oncology settings remain understudied. In particular, there is a paucity of mixed-methods research integrating robust measurement with meaningful narrative inquiry.

Family caregivers of patients with cancer in rural India experience multidimensional strain like emotional, physical, social and financial that is deeply shaped by cultural expectations and infrastructural constraints. Existing studies underscore high rates of psychological distress, yet are limited in contextual depth. A mixed-methods approach combining validated quantitative instruments with a qualitative component is essential to fully understand and address caregiver burden in central rural India. By integrating empirical data with lived experience, this study aims to inform culturally responsive support mechanisms and policies to uplift caregiver wellness and improve patient–family outcomes.

Research objectives

1. To examine the level of caregiver burden among family caregivers of patients with cancer in a rural population of central India.

2. To evaluate the mental health status of the participating caregivers using validated psychometric tools.

3. To examine the association between caregiver burden and mental health outcomes among the study population.

4. To explore the lived experiences, coping mechanisms and available support systems among family caregivers through qualitative inquiry.

Methodology

Study design

The present research adopts a sequential explanatory mixed-methods design (figure 1), integrating both quantitative and qualitative approaches to comprehensively assess caregiver burden and mental health outcomes among study participants. The study is methodically organised into two distinct phases.

Figure 1. Sequential explanatory mixed-method study design. DASS-21, Depression, Anxiety and Stress Scale-21; IDI, in-depth interview.

Phase I will focus on collecting quantitative data using a structured questionnaire administered to all eligible participants. The tool incorporates the Copenhagen Burnout Inventory (CBI) for assessing caregiver burden and the Depression, Anxiety and Stress Scale (DASS-21) for evaluating psychological well-being. These validated instruments are chosen for their strong psychometric reliability and validity in measuring core aspects of mental health. The data generated will be subjected to both descriptive and inferential statistical analyses to identify prevailing patterns, explore associations and determine significant predictors of caregiver stress and psychological outcomes.

Following the quantitative phase, Phase II will be initiated to gather qualitative insights, designed to strengthen and contextualise the numeric findings. A purposive sample of participants is selected for in-depth interviews (IDIs). Prior to the interviews, a structured IDI guide will be developed based on findings and gaps observed in Phase I. IDIs will be conducted in a safe and open environment, encouraging participants to elaborate on their lived experiences. The interviews will be documented through detailed note-taking and subsequently transcribed. These transcripts will then be subjected to manual thematic analysis, allowing the extraction of recurring themes, perspectives and contextual interpretations of caregiver experiences.

The final step will involve integrating findings from both phases to enable a holistic interpretation of the research problem. This triangulation will not only validate the findings across methodological approaches but will also facilitate a deeper understanding of the phenomenon under study. This design allows for the strengths of both quantitative objectivity and qualitative depth to inform meaningful conclusions and recommendations.

Quantitative research section

Sample size

The sample size for this study was calculated using the finite population correction formula for frequency in a population. The calculation was based on the city’s population size of 1 300 000, with the anticipated frequency of cancer caregivers determined from the prevalence of patients with cancer in the population from the Population-Based Cancer Registry which reports 2463 incident cases, at 18.9% (p=0.189).¹¹ A 95% confidence level was selected with confidence limits set at ±0.5% (d=0.005), and a design effect of 1 was applied as no cluster sampling was employed. The calculation using the finite population correction formula yielded a required sample size of 290 participants.¹² Our sample size is both statistically justified and operationally feasible, reflecting a rigorous balance of precision, confidence and resource considerations.

Settings and sample recruitment

A systematic randomised sampling method will be employed to recruit the study participants. The study will include all family caregivers of patients with cancer who meet the inclusion and exclusion criteria from the SGM Cancer Hospital.

In Sawangi (Wardha), Maharashtra, SGM Cancer Hospital is a tertiary care oncology facility connected to Acharya Vinoba Bhave Rural Hospital (AVBRH). Serving the Wardha district and surrounding areas of central India, AVBRH is a teaching hospital situated in a rural area. Serving as the specialised oncology wing, SGM Cancer Hospital offers complete cancer care. With 120 beds, the hospital provides multidisciplinary services such as radiation oncology, surgical oncology and medical oncology. OPD (Out-Patient Department), IPD (In-Patient Department), operative, chemotherapy and radiotherapy services are also provided. The hospital recorded 2207 oncological surgeries, 4997 IPD admissions and 13 088 OPD visits between April and October 2025.

Every department has seen a steady yearly increase in patient volumes. Currently, the attendance at the medical oncology OPD is 8548. Radiation oncology services expanded substantially, with current radiotherapy patients of 1058 and fractions delivered of 11 306, alongside growing brachytherapy services. SGM Cancer Hospital is staffed by a multidisciplinary academic team that includes medical and surgical oncologists, radiotherapists and palliative care experts. This collaborative expertise, coupled with standardised record maintenance, makes it an ideal setting for hospital-based oncology research. The patient load catered by the hospital will provide a strong foundation for the sampling process.

In accordance with the study’s inclusion and exclusion criteria, treating oncologists and unit consultants from medical, surgical and radiation oncology will first screen and identify eligible patients during regular OPD consultations or IPD rounds. The treating physician will give a brief overview of the study and request permission for the research team to speak with the patient once inclusion criteria have been established.

In order to maintain privacy and cause as little disruption to clinical care as possible, the principal investigator will then meet possible participants in specific locations, such as the oncology OPD waiting areas, chemotherapy day-care centres or inpatient wards. The purpose of the study, its procedures and the voluntary nature of participation will all be explained in study information sheets and participant information leaflets that will be distributed in both the local language and English. Additionally, to raise awareness, flyers and posters outlining the study will also be put up at ward notice boards, chemotherapy units, waiting areas and oncology OPD registration counters. Family caregivers who want to volunteer to participate in the study can contact the research team. Prior to enrolment, written informed consent will be obtained. Recruitment will continue until the necessary sample size is reached. Follow-up evaluations will be scheduled to coincide with routine clinical visits which will optimise logistical feasibility and minimise patient inconvenience. This method will enhance generalisability, improve retention and integrate with existing hospital workflows.

Eligibility criteria for samples

Informal caregivers are typically spouses, adult children, partners or close friends. They play a pivotal role throughout the cancer trajectory, providing a broad spectrum of practical, emotional and medical support to patients in home-based and community-based settings. These family caregivers often manage symptom monitoring, medication administration, personal care tasks and logistical coordination (transportation, appointments, financial matters), while offering psychological reassurance and social support.¹³

The family caregiver inclusion criteria are:

• Must be informal (unpaid) primary caregivers aged 18 years or older, who self-identify as the principal individual responsible for direct physical, emotional or medical support of an adult patient diagnosed with cancer.

• Individuals who have provided continuous caregiving for a minimum of 6 months will be included.

• Family caregivers who are willing to give written informed consent to participate in the study.

Caregiver exclusion criteria are:

• Any paid or professional caregivers, including home health aides or nursing staff, to focus on the experiences of informal family caregivers.

• Individuals who have provided care for less than 6 months, including those caring for patients newly diagnosed within the past half-year, are not eligible due to insufficient duration of caregiving exposure.

Family caregivers who meet these criteria and provide voluntary consent will thus form a representative sample for examining long-term caregiver burden, psychosocial stressors and supportive needs in the context of cancer care.^{14 15}

Research instruments

Part 1: sociodemographic and contextual determinants

This section gathers sociodemographic data of the informal caregiver, who is often a close family member or friend providing unpaid support to a patient with cancer. Variables such as the family caregiver’s age, sex, educational status and occupation allow for stratification by socioeconomic and professional domains. Questions on variables such as marital status, number of dependents, family income and average monthly expenses on treatment help identify vulnerability and financial strain. This section also includes a series of contextual questions about the caregiving experience such as the duration of caregiving, travel frequency and distance to the treatment facility, and associated logistical burdens including time and expenses. It also investigates whether family caregivers suffer income loss due to treatment-related obligations or have to incur debt, indicating indirect economic impacts of illness. The inclusion of insurance status serves to understand healthcare access inequities and out-of-pocket expenditure. Simultaneously, relevant clinical parameters regarding the patient are also gathered to contextualise the family caregiver’s experience. These include patient age, sex, cancer type, stage, ongoing treatment modality (chemotherapy, radiotherapy, surgery, palliative care) and the patient’s functional dependency status. Together, these data points offer insight into caregiving intensity, the disease burden and its potential correlation with caregiver distress.

Part 2: psychometric evaluation of burnout (Copenhagen Burnout Inventory)

The second part employs an adapted version of the CBI tailored for informal caregivers.¹⁶ It is subdivided into three burnout dimensions which will be assessed as outcome variables:

Personal burnout

This subscale assesses the general physical and emotional exhaustion unrelated to any specific activity. Respondents are queried about frequency of fatigue, emotional depletion and vulnerability to illness. The phrasing such as ‘I can’t take it anymore’ captures existential distress, often experienced by chronically burdened individuals.

Caregiving-related burnout

This subscale directly explores the toll of caregiving activities. Items assess exhaustion at the end of caregiving days, emotional fatigue specific to caregiving, energy deficits for personal life and the cumulative emotional impact of sustained caregiving. This is critical in delineating burnout attributable specifically to caregiving, rather than life stress in general.

Patient-related burnout

This domain will explore the interpersonal relationship between the family caregiver and the patient with cancer. It will assess perceived frustration, emotional reciprocity and future caregiving sustainability. For instance, questions such as ‘Do you feel that you give more than you get back?’ help probe latent resentment, emotional fatigue or relational strain that may not be overtly expressed but influence caregiver well-being.

Each item uses a frequency-based Likert scale, capturing both intensity and duration of burnout symptoms. This nuanced approach is especially suitable for longitudinal monitoring in clinical or research settings.

Part 3: psychological morbidity screening (DASS-21)

The final section incorporates the DASS-21, a validated psychometric tool to evaluate mental health status across three distinct domains which can be assessed as outcome variables: depression (D), anxiety (A) and stress (S).¹⁷ Each item is scored on a 4-point scale assessing symptom frequency over the past week. This time-bound frame ensures that transient mood fluctuations are accounted for without inflating chronic distress prevalence.

• The depression subscale captures anhedonia, hopelessness and self-worth deficits.

• Anxiety subscale probes physiological and psychological arousal symptoms such as tremors, breathlessness and irrational fears.

• Stress subscale evaluates irritability, agitation and nervous tension, such as over-reactivity and intolerance to delay.

The DASS-21 provides a quantitative measure of psychological morbidity which, when triangulated with the burnout scales and sociodemographic data, can yield meaningful insights into family caregiver support needs.

Data collection and analysis

Data collection will be started and will be continued until the desired sample size is reached between the study period from September 2025 to November 2026. Participants will be recruited from the family caregiving population of patients with cancer receiving treatment at the selected healthcare facility. Informed consent will be obtained, and trained data collectors will administer the questionnaire either face-to-face or via telephonic interviews, depending on feasibility and participant preference.

Data will be collected and will be entered in Microsoft Excel spreadsheet 2021, and the analysis will be done using R Studio V.4.5.0.

• Descriptive statistics will be applied to summarise family caregiver and patient characteristics (means, medians, frequencies, percentages).

• Inferential statistics, including binomial logistic regression, will be used to examine the associations between caregiver burnout and mental health outcomes and a set of potential predictor variables, such as caregiving duration, socioeconomic status and patient dependency level.

The relationship between caregiver burden (primary predictor, measured by the CBI score) and binary mental health outcome (measured by the DASS-21 cut-off) will be examined using binomial logistic regression, which will account for covariates such as age, gender and patient cancer stage through deliberate selection (univariable p<0.25 screening, multivariable p<0.05 retention). Key model assumptions (eg, linearity, no multicollinearity, good fit) will be checked. ORs with 95% CIs will be reported, alongside sensitivity analyses for robust insights.

This approach will help identify key stressors and vulnerabilities within the caregiver population, forming the foundation for deeper qualitative exploration.

Qualitative research section

Sample size

In qualitative research, sample size is guided not by numerical adequacy but by the concept of informational power. It is the degree to which participants provide rich, relevant and contextually grounded data aligned with the study’s objectives.¹⁸ For this study exploring caregiver burden and mental health in the context of caring for patients with cancer, a purposive sample will be selected for IDIs. The selection will aim for maximum variation in caregiver demographics and caregiving experiences to capture diverse perspectives. Interviews will continue until data saturation is achieved, that is, when no new themes emerge from subsequent interviews. This approach ensures methodological accuracy while allowing for flexibility based on emerging data patterns.

Settings and sample recruitment

The study will be conducted at SGM Cancer Hospital, a tertiary care oncology centre that provides comprehensive diagnostic, treatment and supportive care services to patients with cancer. The hospital’s diverse patient base and multidisciplinary care environment offer an appropriate setting to explore the lived experiences and psychological impact on family caregivers. Participants will be recruited using convenient sampling techniques, targeting adult family caregivers of patients currently undergoing active cancer treatment and ensuring a balanced representation of both male and female patients, as well as inclusion across different types of cancers to promote diversity and generalisability of findings. Family caregivers who meet the inclusion criteria will be approached during outpatient visits or inpatient admissions. After providing detailed information about the study, those willing to participate will be enrolled following informed consent. Recruitment will continue until the required sample size is achieved, ensuring adequate representation across caregiver roles, socioeconomic backgrounds and caregiving durations to enhance the rigour and variability of the data collected.

Interview content

The interview content was meticulously developed by the principal investigator, grounded in a thorough review of literature and aligned with the study’s objectives. It aims to elicit comprehensive, contextual and emotionally significant data from participants through a semistructured, IDI format. The guide comprises open-ended questions and thematic sections addressing the lived experiences, coping strategies and support systems of family caregivers of patients with cancer. For example, ‘What are the biggest challenges or hardships you’ve faced while caregiving for your loved one’ (lived experiences), ‘Are there personal habits, religious practices, talking to someone, or family customs that help you manage?’ (coping strategies). Designed to ensure both breadth and depth of response, each section includes prompts and culturally relevant probes to facilitate meaningful discussion while maintaining participant comfort and engagement. Prior to deployment, the guide will undergo content validation by experts in qualitative research and public health, ensuring its appropriateness, clarity and sensitivity. This structured yet flexible approach will allow the interviewer to explore emerging themes while remaining anchored to the study’s core research aims.

Data collection and analysis

The qualitative component will commence in the second phase, building on insights obtained from the quantitative data. A subset of participants will be purposively selected for IDIs using maximum variation sampling to capture diverse caregiving experiences. An IDI guide will be developed based on themes emerging from the quantitative phase and supported in literature on caregiver burden and mental health. Interviews will be conducted in the participant’s preferred language by trained interviewers, ensuring a culturally sensitive and psychologically safe environment. All interviews will be audio recorded (with consent), supplemented with field notes and subsequently transcribed verbatim.

The qualitative data obtained from IDIs will be transcribed verbatim and cross-verified with audio recordings and field notes for accuracy. The transcripts will then undergo manual thematic analysis following the approach described by Braun and Clarke.¹⁹ A mixed approach, that is, deductive and inductive approaches, for data analysis to focus on our study objectives and allow new information to emerge during the coding process will be used. This process will include the steps of data familiarisation, open coding and theme development through inductive and literature-informed approaches. Emergent codes will be organised into categories and refined into coherent themes that reflect family caregiver experiences, emotional responses and coping strategies. To ensure analytical precision and credibility, coding will be conducted independently by two researchers, with discrepancies resolved through discussion or third-party adjudication. Where feasible, member checking by the independent researchers will be performed to validate interpretations and ensure alignment with participants’ intended meanings.

The final thematic framework will aim to capture the lived experiences, perceived stressors, resilience strategies and healthcare system interactions of family caregivers in a manner that complements and deepens the findings from the quantitative phase. This contextual understanding will form the basis for recommendations aimed at improving psychosocial support interventions for family caregivers in oncology care.

Ethics and dissemination

Ethical clearance for this study was obtained from the Institutional Ethics Committee of Datta Meghe Institute of Medical Education and Research, Sawangi (Meghe), Wardha (Approval No. DMIHER(DU)/IEC/2025/436). Permission for data collection was further granted by both the institutional ethics committee and AVBRH, Sawangi (Meghe), Wardha. The study protocol was approved and registered with the Clinical Trial Registry, India under reference number CTRI/2025/08/093357. The findings of this research will be disseminated through publications in peer-reviewed scientific journals and by engaging relevant stakeholders through appropriate channels of communication.

Discussion

Caregiver burden in the Indian oncology context is established in multiple stress domains like emotional, financial, physical and psychosocial. For instance, a study conducted at Tata Memorial Centre among 127 family caregivers of older patients with cancer documented that 19.7% experienced mild-to-moderate, and 3.1% moderate-to-severe burden.² A separate prospective observational study of 178 caregivers showed that approximately 70.2% reported mild-to-moderate burden, while 21.4% had moderate-to-severe burden.²⁰

These quantitative findings underscore significant psychological morbidity and distress among caregivers, echoing broader literature on caregiver syndrome and burnout, where symptoms such as chronic stress, anxiety, sleep disturbances and physical inflammation have been documented. Financial constraints are another critical dimension. In India, cancer caregiving often entails catastrophic out-of-pocket expenses due to limited insurance coverage and high dependency on family financing, affecting approximately 26.7 million cancer survivors nationally, with over 1.4 million new cases annually.³

This protocol addresses a critical gap in oncology care by systematically examining the multidimensional burden faced by informal caregivers of patients with cancer in India. Empirical data show that caregivers in low and middle-income countries spend an average of 42% of their annual income on out-of-pocket medical and non-medical costs associated with cancer care, compared with 16% in high-income settings.²¹ In India specifically, median out-of-pocket expenditure ranges from ₹35 000 to ₹3.1 lakh, depending on cancer stage and treatment intensity.²² The financial constraints are immense: nearly all households (up to 99.7%) face catastrophic health expenditures when both direct and indirect costs are considered.^{23 24}

Psychological burden is similarly profound. Caregivers struggle with moderate-to-severe burden, compounded by anxiety, depression and chronic stress symptoms such as sleep disturbance, somatic illness and immune compromise. These findings underscore the urgent need for focused research.

The mixed-methods approach of this protocol, integrating validated quantitative tools with qualitative thematic analysis, offers a robust framework to quantify prevalence, identify predictors and contextualise caregiver experiences in their own voices. The study’s findings will support evidence-based proposals for person-centred interventions, including peer and respite support, financial counselling and integrative mental health services.

The findings of this study will hold significant translational value in informing the development of contextually appropriate and evidence-based caregiver support frameworks within oncology settings in India. Given the multifaceted burden faced by family caregivers, there is a compelling need to integrate structured support mechanisms into cancer care delivery. The data generated from this mixed-methods approach can guide the strategic allocation of resources toward scalable interventions such as respite care services, which offer temporary relief to primary caregivers; peer support groups, which foster shared experiences and emotional solidarity; and financial assistance programmes, which can alleviate the economic strain resulting from prolonged caregiving responsibilities and out-of-pocket medical expenditures. These support models, tailored to the sociocultural realities and healthcare access limitations prevalent in Indian settings, can enhance caregiver well-being, reduce burnout and ultimately contribute to improved patient outcomes through sustained and effective informal caregiving. Including such interventions in everyday cancer care is not just about improving the health system, it is also about supporting families and caregivers, making sure they are not left behind and helping create a more compassionate and inclusive approach to cancer treatment, that is, holistic cancer care.