Improving Access to Control of Diseases for Women

Breast Cancer Clinical Trial

— IMPACD  

Official title:

Improving Access to Control of Diseases for Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604939
• Other study ID #: DCA/SCR/2016/01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2021
• Source: International Agency for Research on Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: July 1, 2019
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Cardio-vascular Disease
• Cardiovascular Diseases
• Cervical Cancer
• Mouth Neoplasms
• Oral Cancer
• Stroke Cancer
• Uterine Cervical Neoplasms
• Vascular Diseases

Intervention

Diagnostic Test:
• Evaluation of social, cultural and behavioral factors
Evaluation of the social, cultural and behavioral factors that impact the uptake of the NCD prevention and control services among women, using the RARE methodology
• Evaluation of the feasibility and acceptability of delivery of early detections services
Evaluation of the feasibility and acceptability of delivery of the NCD early detections services by the trained community health workers at home settings

Locations

Country	Name	City	State
India	GBH Cancer Memorial Hospital	Udaipur	Rajasthan

Sponsors (2)

Lead Sponsor	Collaborator
International Agency for Research on Cancer	GBH Cancer Memorial Hospital Udaipur, India

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Outcomes of the questionnaire survey 3/5	proportion of the participants with a diagnosis of hypertension who adhere to the treatment advised	1 year
Primary	Outcomes of the questionnaire survey 4/5	proportion of the participants with a diagnosis of diabetes who adhere to the treatment advised	1 year
Primary	Outcomes of the questionnaire survey 5/5	proportion of the participants with a diagnosis of cancer who adhere to the treatment advised	1 year
Primary	NCD Screening study 1/11	screen positivity - proportion of the screened participants detected to have high blood pressure	1 year
Primary	NCD Screening study 2/11	screen positivity - proportion of the screened participants detected to have high BMI	1 year
Primary	NCD Screening study 3/11	screen positivity - proportion of the screened participants detected to have abnormal HPV detection test	1 year
Primary	NCD Screening study 4/11	screen positivity - proportion of the screened participants detected to have abnormal oral examination test	1 year
Primary	NCD Screening study 5/11	screen positivity - proportion of the screened participants detected to have abnormal visual examination test	1 year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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