Effectiveness of an intervention package (oral self-examination, oral scrape cytology based screening and mHealth) to increase the oral cancer screening

Not yet recruiting

Conditions: Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,

Registration Number: CTRI/2023/11/060380

Lead Sponsor: Dr. Sana Anwar

Brief Summary: 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 â‰¥ 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

Adults aged 30 years and above 2.
Residing in the field practice areas of selected urban PHCs (UPHCs) which are not under CUHA, selected UPHCs under CUHA and PHC and CHC under CRHA.
for most of the last six months.
Either owning a mobile phone themselves or having at least one member of their family living in the same household owning a mobile phone.

Exclusion Criteria

Persons living with diagnosed oral cancer and currently on treatment.
Participants not present at home even after two follow up visits during initial recruitment and post intervention follow up survey.
Those refusing consent for the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage change in number of screened population positive for both OSE & oral scrape cytology screening, population screened positive in OSE, number of OSE positive self referring themselves for oral scrape cytology screening, Proportion of population screened positive in OSE & underwent oral scrape cytology screening, number of cytology positive selfreferring & referral by ASHA, change in level of awareness, knowledge, attitude & skills, frequency of OSE ,proportion of calls to ASHA, delayed calls, population receiving pamphlets & videos from ASHA ,reach, adoption, fidelity & implementation cost.	Baseline data collection starts at 0 months . \| Follow up after 12 months

Secondary Outcome Measures

Name	Time	Method
no secondary outcomes	no secondary outcomes

Trial Locations

Locations (1): AIIMS Bhopal
🇮🇳
Bhopal, MADHYA PRADESH, India
AIIMS Bhopal
🇮🇳Bhopal, MADHYA PRADESH, India
Dr Sana Anwar
Principal investigator
9818526196
sana.phd2022@aiimsbhopal.edu.in