Improving Access to Control of Diseases for Women

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EstadoTerminado

Patrocinadores

International Agency for Research on Cancer

Colaboradores

GBH Cancer Memorial Hospital Udaipur, India

ENSAYO CLÍNICO: NCT03604939

BioSeek: nct03604939

Palabras clave

Abstracto

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.

Descripción

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

fechas

Verificado por última vez:	06/30/2018
Primero enviado:	08/16/2017
Inscripción estimada enviada:	07/19/2018
Publicado por primera vez:	07/29/2018
Última actualización enviada:	07/19/2018
Última actualización publicada:	07/29/2018
Fecha de inicio real del estudio:	12/31/2016
Fecha estimada de finalización primaria:	06/30/2018
Fecha estimada de finalización del estudio:	06/30/2018

Condición o enfermedad

Cardio-vascular Disease

Stroke Cancer

Breast Cancer

Oral Cancer

Cervical Cancer

Intervención / tratamiento

Diagnostic Test: Evaluation of social, cultural and behavioral factors

Diagnostic Test: Evaluation of the feasibility and acceptability of delivery of early detections services

Fase

Criterio de elegibilidad

Edades elegibles para estudiar	30 Years A 30 Years
Sexos elegibles para estudiar	Female
Acepta voluntarios saludables	si
Criterios	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.

Salir

Medidas de resultado primarias

1. 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

2. 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

3. Outcomes of the questionnaire survey 3/5 [1 year]

proportion of the participants with a diagnosis of hypertension who adhere to the treatment advised

4. Outcomes of the questionnaire survey 4/5 [1 year]

proportion of the participants with a diagnosis of diabetes who adhere to the treatment advised

5. Outcomes of the questionnaire survey 5/5 [1 year]

proportion of the participants with a diagnosis of cancer who adhere to the treatment advised

6. NCD Screening study 1/11 [1 year]

screen positivity - proportion of the screened participants detected to have high blood pressure

7. NCD Screening study 2/11 [1 year]

screen positivity - proportion of the screened participants detected to have high BMI

8. NCD Screening study 3/11 [1 year]

screen positivity - proportion of the screened participants detected to have abnormal HPV detection test

9. NCD Screening study 4/11 [1 year]

screen positivity - proportion of the screened participants detected to have abnormal oral examination test

10. NCD Screening study 5/11 [1 year]

screen positivity - proportion of the screened participants detected to have abnormal visual examination test

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

Medidas de resultado secundarias

1. 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

Improving Access to Control of Diseases for Women

Palabras clave

nicotina

cáncer de mama

cáncer

accidente cerebrovascular