Brief Intervention for Tobacco when Diagnosed with Oral Cancer (BITDOC): Study protocol of a randomized clinical trial studying efficacy of brief tobacco cessation intervention, Chhattisgarh, India

INTRODUCTION: Tobacco use is a major causative factor for cancer. Cessation programs along with diagnosis of cancer as a motivating factor may improve quitting rates in patients. This is a protocol of a study that aims to assess the efficacy of brief tobacco cessation intervention (compared to treatment as usual, TAU) on pattern and attitudes towards tobacco chewing in newly diagnosed head and neck cancer patients and their relatives. METHODS: The proposed study will be conducted in two phases. Phase 1 will include 105 dyads of patients and relatives and shall assess patterns (amount, frequency, duration of use and dependence etc.) and knowledge and attitudes (quitting, continued use, health-behavioural modifications, long-term effects on treatment etc.) towards tobacco chewing in newly diagnosed head and neck cancer patients using smokeless tobacco and their relatives. Sample will be recruited from outpatients attending the ear, nose, throat and head and neck surgery department of a tertiary health care institute. Phase 2 will be a randomized trial that will compare the efficacy of the ‘Brief Intervention for Tobacco when Diagnosed with Oral Cancer’ (BITDOC) and TAU, and will include 27 dyads in each of the two groups. Intervention will be delivered in three sessions, based on the principles of motivational interviewing and the 3As model. CONCLUSIONS: This study will help in the evaluation of the attitude towards smokeless tobacco (SLT) in a population that has faced the adverse consequences from its use and changes brought by a diagnosis of HNC. It will also help in developing a cost-effective model for promotion of smoking cessation.