INTRODUCTION

Head-and-neck cancer (HNC) ranks seventh in terms of global cancer prevalence, with around 57.5% and 30% in Asia and India, respectively, with a greater occurrence in the northeastern region of the country. The major concern is increased incidence on the one hand and the lower cure rates in comparison to the developed nations. The advanced stage at diagnosis, poor compliance to treatment and lack of healthcare facilities are the important contributors to low cure rates. Improper pain management is considered a significant contributing reason to poor compliance. Effective pain management can enhance both quality of life and treatment compliance.[1,2]

Pain is one of the most common symptoms in HNC patients. A recent review of the literature revealed that 64% of patients with cancer report pain as a chief complaint, 59% of the patients receiving anticancer treatment report pain and 33% of the patients complain the same even after completion of curative treatment.[3] Unawareness or difficulty in recognising pain as a problem leads to significant distress, treatment-related breaks and non-compliance towards cancer treatment.[4,5] It is vital to assess and manage pain in the initial visit and also follow it through the entire treatment course to improve overall quality of life and cancer treatment.[5,6] To summarise, cancer-related pain is to be treated as effectively as cancer itself.[6]

This study aims to evaluate the role of the Quantitative Improvement Programme (QIP) for pain assessment and its association with treatment compliance in newly diagnosed HNC patients treated with curative intent presenting to the surgical oncology outpatient department (OPD) from January 2022 to August 2023 at the tertiary cancer care centre in Northeast India.

MATERIALS AND METHODS Study design

This was a cohort study involving a record review of secondary programme data.

General setting

Cachar Cancer Hospital and Research Centre (CCHRC) was initially established in 1992 by Cachar Cancer Hospital Society as a not-for-profit non-governmental Organisation (NGO) in Silchar. 80% of the population visiting the hospital are daily wagers facing financial and transport difficulties; HNC patients constitute around 40% of total patients presenting to surgical oncology OPD. Furthermore, around 85% of these patients are beneficiaries of various government schemes including Ayushman Bharat and Pradhan Mantri Jan Arogya Yojana schemes and funds from NGOs.

Pain management at CCHRC

Most of the HNC patients presenting to CCHRC with a chief complaint of pain are treated with non-steroidal anti-inflammatory drugs and opioids, depending upon the severity. In December 2022, a quality control programme which included training all healthcare workers on pain management and mandatory documentation of pain scores as the fifth vital sign was implemented. This is a National Cancer Grid (NCG) healthcare quality improvement programme developed to improve the awareness of quality pain assessment and management amongst healthcare workers working in the OPD, thereby causing changes in patient compliance.[7] The NCG QI Hub aims to initiate, inculcate and integrate the culture of quality through its immersion educational initiative EQuIP-India - the educational program provides the participants with conceptual understanding and an immersion experience necessary to respond to quality-related problems across a complex environment such as clinical practice settings. We implemented the QIP in December 2022 and categorised the study population as non-implemented group (NIG) (January 2022–December 2022) and implemented group (IG) (January 2023–August 2023) in which we have done a root cause analysis and pareto frequency charting to identify the most common cause and established key drivers and necessary interventions, one of the main key drivers is to compulsory pain assessment and which we added as fifth vital sign in OPD setting, which was recorded before routine clinical examination and later as a part of sustainable intervention, we added digital documentation of pain score in hospital management software (HMS). The pain assessment was scored from 0 to 10 using a numerical rating scale.

Study population

The study population included newly diagnosed HNC patients with curative intent, presenting to surgical oncology OPD between January 2022 and August 2023.

Inclusion criteria

All patients aged more than 18 years with histologically confirmed diagnoses of squamous cell carcinoma of the head and neck were planned for curative treatment in the study period between January 1, 2022, and August 31, 2023.

Data variables, sources of data and data collection

A list of all new HNC patients with curative intent was extracted from HMS, and missing data were retrieved from patient case records. Both were extracted into electronic data using online EpiCollect5 software. Variables included sociodemographic variables (unique ID, age, sex, type of tobacco: Smoking/smokeless/both, alcohol history), clinical variables (performance status, pain assessment, stage and site of cancer) and treatment-related variables (date of diagnosis, plan of treatment, date of initiation of treatment, date of end of definitive treatment, end of treatment response date of last follow up, status at last follow-up and date of relapse).

Operational definitions Non-compliance (Defaulter)

Patients missing the scheduled treatment appointment and not responding to telephone calls for more than 2 weeks were considered non-compliant. A patient who was receiving treatment elsewhere was not considered as non-compliant or a defaulter.

Unfavourable event

Any relapse, death or treatment failure (not achieving complete remission at the end of definitive treatment) was considered as an event.

Treatment abandonment

Any patient diagnosed as HNC but did not return for the initiation of treatment was considered treatment abandonment.

Statistical analysis

Descriptive analysis was performed by means of proportions for sociodemographic variables (age, sex, tobacco and alcohol use) and clinical factors (comorbidities, those assessed for pain, treatment initiated, etc.) wherever appropriate. Statistical differences between means of quantitative variables with respect to sociodemographic factors, pain scores and cancer stage were calculated using the Mann–Whitney test (non-normal distribution). The Chi-square test was used to study the association between categorical variables. The associations between the compliance and linico-socio-demographic risk factors were expressed as risk ratio (RR) (adjusted with 95% confidence intervals [CI]) using logistic regression in the Statistical Package for the Social Sciences version 17.0. P<0.05 was considered statistically significant. Ethics approval was obtained from the Institutional Review Board, CCHRC, Silchar, India (ECR/925/Inst/AS/2017/RR-21, dated 13 April 2024. As the study involved a review of patient records (secondary programme data), a waiver for written informed consent was obtained.

RESULTS Sociodemographic characteristics

A total of 314 HNC patient records were analysed. Two hundred four patients were in the NIG (January 2022–December 2022), and 110 patients were in the IG (January 2023–August 2023). The mean age of patients in our study was 57 years. The male-to-female ratio was 3:1. In this study, all the patients used some form of tobacco, of which 55% were smokeless tobacco users, 6% were smokers, and 39% of patients used both. The majority of patients reported alcohol use (80–87%), and one-third (33%) of the patients were found to be underweight [Table 1].

Table 1: Sociodemographic characteristics of newly diagnosed head-and-neck cancer patients assessed for the quality improvement programme of pain assessment and management between implemented and non-implemented groups in a tertiary cancer centre.

Characteristics Quality Control Programme Total (n=314) Non-Implemented Implemented n % n % n % Age   18–39 years 10 4.9 10 9.1 20 6.4   40–64 years 126 61.8 71 64.5 197 62.7   Above 64 years 68 33.3 29 26.4 97 30.9 Sex   Male 155 76.0 84 76.4 239 76.1   Female 49 24.0 26 23.6 75 23.9 Tobacco habit   Smoking 4 2.0 15 13.6 19 6.1   Smokeless 115 56.4 56 50.9 171 54.5   Both 85 41.7 39 35.5 124 39.5   Non-user 0 0 0 0 0 0 Alcohol use   No 27 13.2 21 19.1 48 15.3   Yes 177 86.8 89 80.9 266 84.7 Body mass index   Underweight (<18.5) 72 35.3 31 28.2 103 32.8   Normal (18.5–24.9) 108 52.9 73 66.4 181 57.6   Overweight (25–29.9) 19 9.3 6 5.5 25 8.0   Obese (>30) 5 2.5 0 0.0 5 1.6 Clinical characteristics

Table 2 summarises the various clinical characteristics in the entire study group and subgroups based on the quality control implementation program. In our study, patients with oral cavity cancer constituted 39%, followed by oropharynx and hypopharynx cancer, both constituting 25% each. Most of the patients (39%) presented with stage III, followed by stage II in 28% and Stage IVa in 17% of the patients. Only 15% of the patients were found to be non-compliant with the treatment. Hypopharynx cancer was more common in the NIG (26%) than in the IG (21%), whereas oropharynx cancer was less common in the NIG when compared to IG (21% and 31%, respectively).

Non-compliance to treatment was found in 41% (85) of patients in NIG and 39% (43) in the IG. Of the 204 patients in the QIP NIG, treatment abandonment was seen in 46 patients (23%), whereas in IG (110 patients), treatment abandonment was seen in only 18 patients (16%). Pain assessment was carried out in 63% (120) of patients in NIG and 86% (95) patients in the IG and was found to differ significantly (P < 0.0001) between the groups. Complete response at the end of treatment was similar (91%) in both groups. Unfavourable events (relapse, death and treatment failure) were seen in 14 (7%) patients of NIG and 5 patients (4%) of the IG.

Table 2: Clinical characteristics of newly diagnosed head-and-neck cancer patients assessed for the quality improvement programme of pain assessment and management between implemented and non-implemented groups in a tertiary cancer centre.

Characteristics Quality Control Programme Total (n=314) Non-Implemented Implemented n % n % n % Tumour site   Oral Cavity 86 42.2 37 33.6 123 39.2   Oropharynx 43 21.1 35 31.8 78 24.8   Larynx 18 8.8 10 9.1 28 8.9   Hypopharynx 54 26.5 24 21.8 78 24.8   Nasopharynx 3 1.5 4 3.6 7 2.2 TNM staging   Stage I 15 7.4 1 0.9 16 5.1   Stage II 56 27.5 32 29.1 88 28.0   Stage III 77 37.7 46 41.8 123 39.2   Stage Iva 37 18.1 17 15.5 54 17.2   Stage IVb 15 7.4 10 9.1 25 8.0   Not recorded 4 2.0 4 3.6 8 2.5 Histopathology grade   Well differentiated 112 54.9 67 60.9 179 7.0   Moderated differentiated 82 40.2 32 29.1 114 36.3   Poorly differentiated 10 4.9 11 10.0 21 6.7 Performance status   0 7 3.4 3 2.7 10 3.2   1 171 83.8 100 90.9 271 86.3   2 19 9.3 7 6.4 26 8.3   3 3 1.5 0 0.0 3 1.0   4 4 2.0 0 0.0 4 1.3 Pain management   No 79 38.7 11 10.0 90 28.7   Yes 125 61.3 99 90.0 224 71.3 Plan treatment   Unimodality 155 76.0 69 62.7 224 71.3   Bimodality 41 20.1 33 30.0 74 23.6   Tri modality 8 3.9 8 7.3 16 5.1 Comorbidity   No Comorbidity 154 75.5 98 89.9 252 80.5   Single Comorbid 47 23.0 9 8.3 56 17.9   Multiple comorbidity 3 1.5 2 1.8 5 1.6 Compliance to treatment   Compliant 175 85.80 93 84.50 268 85.40   Non-compliant 29 14.20 17 15.50 46 14.60 DISCUSSION

This study is the largest single-centre study from India to document the role of QIP in the management of newly diagnosed HNC. In our study, more than two-thirds of patients presented with pain as an initial symptom and the implementation of QIP significantly increased the proportion of pain assessment along with pain management, decreased non-compliance by 3% and treatment abandonment by 6%. QIP in oncology has shown their impact on treatment outcomes. Kamal and Krzyzanowska[8] discussed the necessity of sharing real-world experiences as delivering cancer faces complex situations. This study was done initially as part of NCG-EQuiP[7] as pain is one of the most common factors in patients presenting with HNC often neglected. Ghei and Khot discussed about 80% of HNC patients present with pain.[6]

In our study, nearly 70% of our patients reported pain, which is correlated with van den Beuken-van Everdingen et al.[3] study where the prevalence of pain in cancer patients ranged from 52% to 77%; in HNC patients, it was mentioned to be significantly higher and one of the primary symptoms experienced by patients. The reason might be due to the advanced nature of the disease at the time of initial presentation. 7 out of 10 patients had stage 3 or stage 4 at the time of treatment initiation. Pain was assessed and managed in 86% and 62% of IG and NIG, respectively, leading to effective management.

The mean age of the study group was around 57 years. Our findings are consistent with other studies reported from India. In our study, all the patients were tobacco users, of which 90% were using some form of smokeless tobacco. A higher prevalence of tobacco use amongst HNC in comparison with Western studies is reported in various Indian studies. A study from Northeast India by Bhattacharjee et al. reported similar findings of high usage of tobacco, particularly the smokeless form.[9-11] In our study, 87% of the population had a history of alcohol consumption. Oswal et al.[12] conducted a district-level household survey to determine the prevalence and determinants of alcohol consumption in the North East Region (NER), which showed a higher prevalence of consumption of alcohol in males; homemade alcohol drinks are very popular in Assamese culture and tribal populations. Data from the National Family Health Survey-4 2015–2016 showed a higher use of the NER, 71%, compared with 50 % in the rest of India.[12] In our study, 4 out of 10 had oral cancer subsite, which is similar to the findings of Chauhan et al. and contrary to the findings of Bhattacharjee et al. and Kulkarni.[9-11]

In our study, QIP led to significant improvement in pain assessment and management and a decrease in treatment abandonment. Although the compliance rate was better in IG, it was not statistically significant. The reason might be due to the small sample size, short follow-up period and missing data. Ours is the first study to report the effectiveness of the QIP for pain assessment and management. Most of our literature review cites the following barriers as the reasons for ineffective management such as poor pain assessment, lack of knowledge, reluctance to prescribe opioids, unavailability of drugs and lack of sensitisation amongst health workers.[4,13] Implementation of QIP has helped us to overcome these barriers. The study findings necessitate QIP for effective pain management and mandate pain score as the fifth vital sign during the management of HNC patients in all cancer centres.

Limitations

The key limitations are the missing data in case records, the absence of serial pain scores and the quality of life assessment.

CONCLUSION

In our study, QIP resulted in efficient pain assessment and management, enhanced patient compliance and reduced rates of treatment abandonment. Delivering quality cancer care is difficult in complex situations. QIP helps in many aspects of health care, particularly cancer in resource-limited settings, thereby reducing treatment abandonment and improving patient compliance.