Evaluating the impact of culturally specific patient-centric behavioral intervention package versus usual care for tobacco cessation among patients attending noncommunicable disease clinics in North India: A single-blind trial pilot study protocol

BACKGROUND: In a low and middle-income country (LMIC) like India, non—communicable diseases (NCDs) contribute a major proportion (61.8%) of all causes of death. Out of this, 48% of cardiovascular diseases , 23% of Chronic Respiratory Diseases , and 10% of Cancer deaths are attributable to tobacco use. Tobacco use is a major risk factor for NCDs and thus, the tobacco cessation approach is a high priority intervention to combat complications and death among NCD patients. While several interventions are available for tobacco cessation, in resource constraint countries like India, the effectiveness of low-cost, culturally specific patient-centric tobacco cessation behavioral intervention holds a potential that needs to be evaluated. A newly developed evidence-based tobacco cessation intervention package will be compared with the existing/usual care provided under the National Programme for Prevention and Control of Cancers, Diabetes, Cardiovascular Diseases, and Stroke (NPCDCS) at NCD clinics. METHODS AND DESIGN: 2 arm, parallel-group randomized controlled trial. PARTICIPANTS: Patients aged ≥30 years suffering from NCD, currently using tobacco, and attending NCD clinics in 2 districts of Punjab, India. SAMPLE SIZE: A total of 200 participants meeting the selection criteria will be recruited. They will be allocated either to the intervention arm or control (usual care) arm (100 each) using block randomization. INTERVENTION: For the participants, there will be 4 face-to-face disease-specific cessation counseling sessions, disease-specific pamphlets, short text messages in vernacular language, that is, Punjabi. Follow-ups will be done at the third, sixth, ninth, and 12th months. PRIMARY OUTCOME: Seven-day abstinence, biochemically verified by plasma cotinine levels. SECONDARY OUTCOME: Quit attempts, number of sticks/number of times of smokeless tobacco usage in a day, and stage of behavior change in tobacco users. DISCUSSION: This multicomponent culturally specific-patient-centric behavioral intervention package for tobacco cessation at NCD clinic settings focusing on the individual, family, and social environment could increase the outreach of cessation services using existing resources, thereby strengthening health systems and enhancing the quality of life of NCD patients. TRIAL REGISTRATION: The protocol for the study has been registered with the Clinical Trials Registry in India under the registration number CTRI/2018/01/011643.