|Year : 2020 | Volume
| Issue : 1 | Page : 25-30
Efficacy of a cashless scheme in rural India to improve outcomes in head and neck cancer patients
Pallavi Kalbande, Virendra Vyas, Ashok Singh, Jay Phate
Department of Radiation Oncology, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sevagram, Maharashtra, India
|Date of Submission||29-Jan-2020|
|Date of Acceptance||23-May-2020|
|Date of Web Publication||08-Jul-2020|
Dr. Pallavi Kalbande
Department of Radiation Oncology, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sevagram, Wardha, Maharashtra,
Source of Support: None, Conflict of Interest: None
Purpose: Treatment of head and neck cancer is toxic, costly, and challenging in underserved population of India; adherence to treatment is the key predictor of the outcome. Objective: The aim of this work was to study compliance with radiotherapy (RT) in beneficiaries of a cashless scheme, namely Mahatma Jyotiba Phule Jan Arogya Yojna (MJPJAY), and factors associated. Materials and Methods: Head and neck cancer patients eligible for curative intent RT and beneficiaries of the cashless scheme registered at a rural tertiary cancer center were included in the study. Noncompliance was studied for association with age, sex, stage of disease, primary site, distance to travel, radical surgery, concurrent or neo-adjuvant chemotherapy, poverty level, and education. Results: Of the 228 patients, 128 (56.14%) defaulted to start RT after approval of the package and 55 (24.12%) have completed treatment without a gap. Conclusion: A large number of patients are defaulting even after approval of the cashless package to initiate RT. Patients with early-stage cancer, who are undergoing radical surgery, with lesser distance to travel, with higher education, who are above poverty level are more likely to start treatment. Whereas employed patients, patients with lesser distance to travel, with higher education are more likely to complete their prescribed RT.
Keywords: Compliance, head and neck cancer, radiotherapy
|How to cite this article:|
Kalbande P, Vyas V, Singh A, Phate J. Efficacy of a cashless scheme in rural India to improve outcomes in head and neck cancer patients. J Curr Oncol 2020;3:25-30
| Introduction|| |
Head and neck cancers are most common among males in India, constituting 16.3% of all cancers according to Globocan 2018. Early diagnosis and completion of treatment form the cornerstone in the cure of head and neck cancers. Head and neck squamous cell carcinoma (SCC) in rural India differ from those in the Western World in terms of age, site of disease, etiology, molecular biology, and outcomes. Around 80–90% of oral cancers are directly attributable to tobacco use. Poverty, illiteracy, advanced stage at presentation, older age of diagnosis, lack of access to health care, poor family support, and poor treatment infrastructure pose major challenges in the management of these cancers. Treatment cost and availability are the major obstacles affecting the outcome in cancer patients in rural India. The annual GDP (gross domestic product) spent on health care is very low in developing countries like India when compared with developed countries. Cancer treatment leads to a significant financial burden on cancer patients and their families. Considering this, to improve outcomes in cancer patients, the state government has started a cashless scheme in 2012 by name Mahatma Jyotiba Phule Jan Arogya Yojna (MJPJAY). The scheme covers complete treatment for cancer patients including surgery, chemotherapy, radiotherapy (RT) with to and fro travel expenses. MJPJAY has improved the number of cancer patients registered and treated for cancers like breast, ovary, cervix, prostate, lymphoma. In head and neck cancer, the number of cases registered increased but not treated proportionally. The tertiary cancer care center Sevagram is equipped with Clinac ix and Cobalt-60, catering population of approx. 25 lakh according to the 2011 census in rural central India. Head and neck cancer is the commonest malignancy presenting at the center. The number of new cases registered of all cancers for a year is approximately 1100–1200 and that of head and neck cancers is approx. 300–400. RT is an integral part of the management of head and neck cancer. The most commonly prescribed RT uses conventional fractionation with 1.8–2.2 Gy per fraction for five fractions in a week to a total dose of 60–70 Gy over 6–7 weeks. Clinical evidence suggests that the radiation dose and duration of treatment (overall treatment time) is correlated with tumor control and survival. Failure to complete RT without interruption has been associated with inferior tumor control affecting survival. Overgaard et al. have shown the importance of overall treatment time in patients with SCC of the head and neck. We thus sought to perform an analysis of compliance to RT among beneficiaries of the cashless scheme in head and neck cancer patients. Our intention is to use these data for shaping future public health efforts toward increasing outcomes in head and neck cancer patients.
| Materials and Methods|| |
Retrospective analysis was done by reviewing hospital records of newly registered head and neck cancer patients for the year 2016 from January to December. Ethical clearance was obtained from the institutional ethics committee. Patients with histopathologically proven SCC of the head and neck region were included for the analysis. Nonsquamous histologies such as adenocarcinoma, adenoid cystic carcinoma, and melanoma were excluded. Ca Nasopharynx and salivary gland, maxilla were not included because of different AJCC-TNM (7th edition) staging system. Recurrent, metastatic, and Stage IVB and IVC cases were excluded. Only beneficiaries of the cashless scheme for curative intent RT were included. Patients not eligible for the cashless scheme were excluded. The total dose of radiation prescribed was 60–70 Gy in 30–35 # with or without concurrent cisplatin (weekly 40 mg/m2), after complete investigational work up. All patients were followed up regularly. All treatment records were analyzed with respect to their demographic and treatment details. According to their compliance to start and to complete treatment, patients were analyzed at two steps, that is, at the start and at the completion of RT.
To start RT after completion of investigational work up and approval of the cashless scheme package.
To complete prescribed RT treatment with a treatment break of less than 1 week.
Investigational work up after registration included complete blood count, renal function test, liver function tests, chest x-ray, and histopathological review. Factors such as age, sex, stage, Body surface area, surgery, employment, education, poverty level, neo-adjuvant chemotherapy, concurrent chemotherapy, distance to travel were analyzed.
Data were collected in Microsoft Excel 2007 and analyzed using GraphPadPrism, 8.2.1 version. Odds ratios were calculated with a 95% confidence interval to see the strength of association and statistical significance for each categorical variable.
| Results|| |
A total of 228 patients were included; of which 179 (78%) were males and 48 (21%) were females. The median age of presentation was 50 years with a wide range of ages from 26 to 80 years. Carcinoma oral cavity was commonest, whereas carcinoma pharynx was the least frequent diagnosis. Site-wise distribution is shown in [Figure 1].
The percentage of patients presenting in early stage (I and II) was less. A high proportion of patients presented in locally advanced stage (III to IVA) (according to AJCC 7th edition), shown in [Figure 1]. Stage IVA was the most common presentation. The study population also included three patients who were diagnosed with a secondary neck node with unknown primary tumors (SNUPT). These patients were staged as per protocol, with the assignment of stages III, IVA, and IVB for N1, N2, and N3 nodal status. Site-wise distribution is shown in [Figure 2].
Step 1 analysis
Of the 228, 118 (51.75%) patients came for RT simulation; out of them, only 100 (43.8%) patients were compliant to start RT. In total, 128 (56.14%) patients were noncompliant to start RT. These 100 (43.8%) patients were further analyzed for defined categorical variables shown in [Table 1]. Individuals compliant to start RT are 1.22 times more likely to be males,1.26 times more likely <50 years,1.15 times more likely with BSA>1.5, 2.17 times more likely to be employed, 3.75 times more likely to be within a distance of 100 km, 4.6 times more likely to be educated more than secondary. Statistically significant association was found between compliance to start RT and early stage of presentation, radical surgery, less distance to travel, higher education, and above the poverty level.
Patients who defaulted to start RT (n = 128) after approval of the package comprised males (n = 98, 76.5%), females (n = 30, 23.4%), elderly age >50 years (n = 65, 50.7%), presented in locally advanced stage (n = 108, 84.3%), patients without radical surgery (n = 80, 62.5%), unemployed (n = 117, 91.4%), distance to travel >100 km (n = 62, 48.4%), patients educated less than secondary (n = 103, 80.4%), below poverty level (BPL) (n = 36, 28.1%). All 128 patients were contacted telephonically and reasons were asked for not coming to start RT. The most common reasons for noncompliance were fear to RT 58 (45.3%), long distance to travel 13 (10.15%), lack of family support for long duration of treatment 32 (25%), and financial crisis 12 (9.3%). Thirteen patients could not be contacted. Even after telephonic counseling by the treating oncologist, only a less number of patients (n = 4) could get back to start treatment.
Step 2 analysis
One hundred patients started on radical RT were analyzed separately for compliance to complete the prescribed treatment. Out of these 100 patients, 55% (n = 55) has successfully completed their prescribed treatment without a gap of less than 1 week. Categorical distribution of these patients is as shown in [Table 2]. Individuals compliant to complete RT are 1.29 times more likely to be males, 1.13 times more likely <50 years, 1.69 times more likely with BSA>1.5, 4.78 times more likely to be employed, 3.68 times more likely to be within a distance of 100 km, 3.23 times more likely to be educated more than secondary, 3.5 times more likely to be not from BPL, 1.5 times more likely without neoadjuvant chemotherapy. Statistically significant association was found between compliance to complete RT and lesser distance to travel, higher education, and employed patients.
|Table 2: Factors affecting compliance to complete prescribed RT without a gap of less than 1 week, that is, at Step 2|
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Patients who defaulted to complete their prescribed course of RT without a break of less than a week (n = 45) comprised males (n = 37, 82.2%), elderly (aged >50 years; n = 21, 46.6%), locally advanced stage of presentation (n = 33, 73.3%), BSA <1.5 (n = 23, 51.1%), without radical surgery (n = 15, 33.3%), received neoadjuvant chemotherapy (n = 6, 13.3%), unemployed (n = 43, 93.3%), altered fractionation (n = 6, 13.3%), distance to travel >100 km (n = 14, 31.1%), education less than secondary (n = 34, 75.5%), with BPL card (n = 6, 13.3%). All 45 patients were contacted telephonically and reasons were asked. The most common reason for noncompliance was unbearable toxicity 30/45 (66.6%), lack of family support 11 (24.4%), and financial crisis 4 (8.8%). Only two patients were able to get back after telephonic counseling to complete their prescribed treatment.
| Discussion|| |
As per the literature available, in India, a large number of head and neck cancer patients present in locally advanced stages., We have seen similar results in our study. The stage at presentation is a major prognostic factor in all subset of head and neck cancer. A significant difference was seen in 3- and 5-year overall survival as stage advances according to the AJCC TNM staging, 7th edition.
RT is an integral part of multimodality treatment in locally advanced SCC of the head and neck. Concurrent chemotherapy andRT is preferred for tumors of hypopharynx, oropharynx, and when organ preservation is needed. Overgaard et al. have shown the importance of overall treatment time in patients with SCC of the head and neck. They have reported that locoregional control rate, overall survival, and disease-specific survival are significantly dependent on the overall treatment time and that shorter overall treatment time is better. Compliance is a major contributor in cure with RT. In spite of a good prognosis in head and neck cancers with treatment being completed, we are not able to achieve optimal outcomes because of poor compliance. Mohanti et al. have reported higher compliance with curative RT. In our study, compliance to start radical RT was 43.7%, whereas to complete the prescribed RT was 55%. Sharma et al. have reported that advanced stage at presentation, poor general condition, intent of treatment, and presence of comorbidity are not significantly associated with compliance in elderly patients. In our study, we have found that early stage at presentation, radical surgery, higher education, and lesser distance to travel are significant to compliance to start RT. Employed patients, <100 km distance to travel, and higher education are significantly more compliant to complete RT. Other factors like male sex, age <50 years, BSA >1.5, and employment are more likely to start RT. Higher association to complete prescribed RT was seen with females, age <50 years, early stage of presentation, BSA >1.5, radical surgery, without neoadjuvant chemotherapy, conventional fractionation, without BPL card.
Pandey et al. have found that 23.45% of patients were noncompliant to complete RT. A higher association was seen with >100 km distance to travel, unemployment, advanced stage, without BPL card.
Tobacco consumption in the form of chewing or smoking is a common practice among males in rural areas of this region. Head and neck cancers are more prevalent among males (78.6%) than females (21.3%). People in this region of India are highly superstitious and many approach practicing quacks that leads to progression and delay in presentation. Some of them approach first to nearby primary health care centre, but diagnostic tests are not available, which miss some proportion of early cases. In our study, the median age of presentation was 50 years. Anyways, elderly population are the most ignorant ones in the family and they themselves are ignorant about their health. Many times symptoms in early stage are not troublesome. It does not affect their daily routine and daily wage, which contributes to late presentation.
It was observed that compliance to initiate treatment in step 1 analysis was better in young patients compared to the elderly, that is, 46% and 40.9%, respectively. Poor individuals are at a higher age-specific mortality risk than the affluent. Cancer treatment leads to a significant financial burden on patients and their families, which could be a reason for the patients being noncompliant with the treatment. The Government of India provides accessible treatment to poor patients through the cashless scheme. But the results were surprising, even when treatment was provided free of cost for head and neck cancer patients, only 55/258 (21.3%) were completely treated.
It was observed that initiation to RT after approval of the cashless package (Step 1) was a major contributor than compliance to complete RT (Step 2). The average time to get approval for the cashless package was 1–2 days. All patients were treated using a 2D conventional technique. Because of the low volume of patients at our center, the average time to start treatment is only 2–3 days without any delay. Even after telephonic counseling, only 5/128 (3.9%) could get back to start RT. For all patients who has cashless package approval was obtained they would not be treated at any other hospitals in Maharashtra, so it is less likely that these patients have taken any treatment at other hospitals.
Head and neck cancers are one of the most extensively studied cancers. In 2009, Fesinmeyer et al. studied completion of RT in the SEER database on head and neck cancer. They also found that surgery was associated with more likelihood of completing treatment. In our study, as only a small number of patients were started on RT, we could not elicit statistically significant factors affecting compliance to prescribed RT at step 2 analysis. In a developing country like India, a very less amount of GDP is spent on healthcare, in that bulky packages are being given for RT in cancer patients. Along with affordability, other factors like older age at presentation, radical surgery, late stage at presentation, employment, more distance to travel, BPL, and lack of education need to be considered to improve the outcome in head and neck cancer patients in India. Further studies focusing on cost-benefit analysis are needed in these patients.
As only a small number of patients completed RT, we could not elicit statistically significant factors.
| Conclusion|| |
Providing cashless treatment alone does not improve the outcome in head and neck cancer patients. Compliance to initiate RT after approval of a cashless package was a major pitfall as compared to that for completion of prescribed RT which affects the outcome. Statistically significant association was found between early stage of presentation, radical surgery, less distance to travel, higher education, and not having BPL card to start RT. Whereas, less distance to travel, higher education, employed patients are significantly associated to complete prescribed RT. Further randomized controlled trials are needed between cashless beneficiaries and paid patients to see whether cashless schemes are making patients ignorant to come for treatment.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]