Development, field trial, effectivenessand economic evaluation of an integrated public health intervention package to increasethe screening of oral cancer among adults residing in two districts of Madhya Pradeshmixed methods implementation research study

Introduction and Rationale-

Oral cancer is sixth common malignancy globally, while in India, it is third most common malignancy with a five-year survival rate of 52% indicating that most of the cases  are identified later at an advanced stage. Thus, early detection is critical for improving the survival rates. Oral cancers are usually preceded by potentially malignant disorders which are generally asymptomatic at their initiation and may be detected by clinicians on routine oral  visual examination (OVE) and by people themselves through oral self examination (OSE). OSE has been endorsed by NPCDCS as well, which is the flagship programme of government of India for addressing NCDs. Screening is usually recommended once in 5 years but NFHS 4 and 5 data indicates low screening rates in Madhya Pradesh. Review of Indian studies have shown that, oral cancer screening through OSE and oral scrape cytology is a useful screening adjunct to conventional OVE for early detection  of oral cancer and is simple, easy to use, minimal patient discomfort, good patient acceptance, non invasive , cost effective, less time consuming, minimum manpower and equipment requirement. Community Health Officers(CHOs) posted in sub centres and staff nurses posted in PHC with some training can easily be taught how to perform sample collection for oral scrape cytology-based screening for early identification of oral cancer.

Primary objective

1.) To find out the effectiveness, and to conduct economic and implementation evaluation of an integrated public health intervention package (oral self-examination, oral scrape cytology based screening and m Health) for increasing screening for oral cancer among adults aged 30 years and above.

2.) To conduct a situational analysis to document oral cancer screening practices, and to understand  barriers and facilitators with respect to screening, diagnosis, treatment and referral of oral cancer as reported by the different stakeholders involved.

Secondary objective

To find out the socio-demographic, clinical, behavioural, environmental and health system predictors of oral cancer screening.

Methodolgy- mixed-methods intervention design with cluster randomized trial in  community. Qualitative component includes in depth interviews (IDIs) and key informant interview (KIIs) and quantitative component includes cross-sectional survey and semi-structured interviews, questionnaire based survey and health facility survey to be carried out among the healthcare facilities (both government and private) of Bhopal and Raisen district on adults aged 30 years and above . Final sample is 240 i.e. 120 in each arm. ASHAs will be trained for OSE and CHOs for collection of oral scrape cytology sample by the candidate.  The pragmatic cluster randomized trial will be conducted for nine months in three phases. Phase 1(situational analysis), phase 2 (implementation and trial of the complex intervention for oral cancer screening), phase 3(Evaluation of the intervention). Outcome measures will be percentage change in number of screened population, self referral practices, people undergoing oral scrape cytology and change in level of awareness, knowledge, attitude and skills between aged ≥ 30 years) in the intervention arm as compared to usual care arm.

Ethical Consideration- LOP for thesis proposal has been obtained from institutional human ethics committee.