Improving Access to Control of Diseases for Women (IMPACD)

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Breast Cancer; Oral Cancer; Cardio-vascular Disease; Stroke Cancer
• Intervention / Treatment: Diagnostic test: Evaluation of social, cultural and behavioral factors; Diagnostic test: Evaluation of the feasibility and acceptability of delivery of early detections services

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 Type: Interventional
• Enrollment (Actual): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Rajasthan
    • Udaipur, Rajasthan, India, 313001
      • GBH Cancer Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcomes of the questionnaire survey 1/5	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	1 year
Outcomes of the questionnaire survey 2/5	proportion of the participants who know about the common NCDs including cancers and their early symptoms	1 year
Outcomes of the questionnaire survey 3/5	proportion of the participants with a diagnosis of hypertension who adhere to the treatment advised	1 year
Outcomes of the questionnaire survey 4/5	proportion of the participants with a diagnosis of diabetes who adhere to the treatment advised	1 year
Outcomes of the questionnaire survey 5/5	proportion of the participants with a diagnosis of cancer who adhere to the treatment advised	1 year
NCD Screening study 1/11	screen positivity - proportion of the screened participants detected to have high blood pressure	1 year
NCD Screening study 2/11	screen positivity - proportion of the screened participants detected to have high BMI	1 year
NCD Screening study 3/11	screen positivity - proportion of the screened participants detected to have abnormal HPV detection test	1 year
NCD Screening study 4/11	screen positivity - proportion of the screened participants detected to have abnormal oral examination test	1 year
NCD Screening study 5/11	screen positivity - proportion of the screened participants detected to have abnormal visual examination test	1 year
NCD Screening study 6/11	compliance to further assessment - proportion of screen positive participants undergoing further assessment at the primary health center or at the hospital	1 year
NCD Screening study 7/11	positive predictive values of further assessment - proportion of participants with confirmed diagnosis of hypertension among those assessed for high BP	1 year
NCD Screening study 8/11	positive predictive values of further assessment - proportion of participants with confirmed diabetes among those assessed for high sugar	1 year
NCD Screening study 9/11	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	1 year
NCD Screening study 10/11	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	1 year
NCD Screening study 11/11	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis	effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis	1 year

Collaborators and Investigators

• Sponsor: International Agency for Research on Cancer
• Collaborators: GBH Cancer Memorial Hospital Udaipur, India

Publications and helpful links

General Publications

• Mahajan M, Naik N, Jain K, Patira N, Prasad S, Mogri S, Muwonge R, Lucas E, Faruq F, Sankaranarayanan R, Iyer S, Basu P. Study of Knowledge, Attitudes, and Practices Toward Risk Factors and Early Detection of Noncommunicable Diseases Among Rural Women in India. J Glob Oncol. 2019 Apr;5:1-10. doi: 10.1200/JGO.18.00181.
• Basu P, Mahajan M, Patira N, Prasad S, Mogri S, Muwonge R, Lucas E, Sankaranarayanan R, Iyer S, Naik N, Jain K. A pilot study to evaluate home-based screening for the common non-communicable diseases by a dedicated cadre of community health workers in a rural setting in India. BMC Public Health. 2019 Jan 3;19(1):14. doi: 10.1186/s12889-018-6350-4.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: breast cancer; cardio-vascular disease; stroke cancer; oral cancer; cervical cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Uterine Cervical Neoplasms; Cardiovascular Diseases; Vascular Diseases; Mouth Neoplasms
• Other Study ID Numbers: DCA/SCR/2016/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No