Improving Access to Control of Diseases for Women

Not Applicable

Completed

• Conditions: Cardio-vascular Disease; Stroke Cancer; Oral Cancer; Breast Cancer; Cervical Cancer

• Registration Number: NCT03604939
• Lead Sponsor: International Agency for Research on Cancer

Brief Summary

The aim of this study is to evaluate the feasibility and acceptability of the model of delivering CHW-driven home-based comprehensive NCD control services aimed to prevent premature deaths from cardio-vascular diseases, stroke and breast, cervix and oral cancers in the hard-to-reach women.

Detailed Description

Specific objectives of this study are the evaluation of:

1. The social, cultural and behavioral factors that impact the uptake of the NCD control services among rural women using the Rapid Assessment, Response and Evaluation (RARE) approach;

2. The feasibility and acceptability of the strategy to deliver the following NCD control services to the rural women at their homes by the trained CHWs:

* Counselling of the tobacco habitués to give up the practice

* Early detection of hypertension and diabetes to ensure prompt and regular treatment

* Creating breast awareness and ensuring access to prompt diagnosis and treatment of the women with symptoms suggestive of breast cancer

* Screening for cervical cancer by self-collected HPV test and ensuring prompt treatment of screen detected precancers and cancers

* Screening of the habitual tobacco/alcohol users for oral cancer by OVE and ensuring prompt treatment of screen detected precancers and cancers

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-30
• Primary Completion: 2018-08-01
• Study Completion: 2019-07-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

• Women between 30 to 60 years residing in the villages of the Gogunda block in the district of Udaipur in Rajasthan, India, will be eligible to participate.

Exclusion Criteria

• Women suffering from debilitating illnesses, pregnant women and women refusing to participate will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Outcomes of the questionnaire survey 1/5	1 year	proportion of the participants who know about the adverse effect of smoking, chewing tobacco and consuming alcohol on health in general and NCDs in particular
Outcomes of the questionnaire survey 5/5	1 year	proportion of the participants with a diagnosis of cancer who adhere to the treatment advised
NCD Screening study 1/11	1 year	screen positivity - proportion of the screened participants detected to have high blood pressure
NCD Screening study 2/11	1 year	screen positivity - proportion of the screened participants detected to have high BMI
NCD Screening study 5/11	1 year	screen positivity - proportion of the screened participants detected to have abnormal visual examination test
NCD Screening study 11/11	1 year	positive predictive values of further assessment - proportion of participants with confirmed visual premalignant and malignant lesions on examination and/or biopsy among those assessed for positive visual examination
Outcomes of the questionnaire survey 4/5	1 year	proportion of the participants with a diagnosis of diabetes who adhere to the treatment advised
NCD Screening study 3/11	1 year	screen positivity - proportion of the screened participants detected to have abnormal HPV detection test
NCD Screening study 9/11	1 year	positive predictive values of further assessment - proportion of participants with confirmed cervical neoplasias on colposcopy and/or biopsy among those assessed for positive HPV test
Outcomes of the questionnaire survey 2/5	1 year	proportion of the participants who know about the common NCDs including cancers and their early symptoms
Outcomes of the questionnaire survey 3/5	1 year	proportion of the participants with a diagnosis of hypertension who adhere to the treatment advised
NCD Screening study 4/11	1 year	screen positivity - proportion of the screened participants detected to have abnormal oral examination test
NCD Screening study 8/11	1 year	positive predictive values of further assessment - proportion of participants with confirmed diabetes among those assessed for high sugar
NCD Screening study 6/11	1 year	compliance to further assessment - proportion of screen positive participants undergoing further assessment at the primary health center or at the hospital
NCD Screening study 7/11	1 year	positive predictive values of further assessment - proportion of participants with confirmed diagnosis of hypertension among those assessed for high BP
NCD Screening study 10/11	1 year	positive predictive values of further assessment - proportion of participants with confirmed oral premalignant and malignant lesions on examination and/or biopsy among those assessed for positive oral examination

Secondary Outcome Measures

Name	Time	Method
effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis	1 year	effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis

Trial Locations

Locations (1)

GBH Cancer Memorial Hospital; 🇮🇳 Udaipur, Rajasthan, India