Clinical trial NCT03604939: Improving Access to Control of Diseases for Women
Official title: Improving Access to Control of Diseases for Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardio-vascular Disease
Stroke Cancer
Breast Cancer
Oral Cancer
Cervical Cancer
Keywords: cardio-vascular disease
stroke cancer
breast cancer
oral cancer
cervical cancer
Lead sponsor: International Agency for Research on Cancer
Sponsor class: OTHER
Collaborators: name: GBH Cancer Memorial Hospital Udaipur, India
First posted: 2018-07-30
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 35,000 households in 228 villages, among which women between 30 to 60 years residing in the villages of the block are eligible to participate
Primary purpose: SCREENING

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

Eligibility criteria: 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.

Primary outcomes:
measure: Outcomes of the questionnaire survey 1/5
timeFrame: 1 year
measure: Outcomes of the questionnaire survey 2/5
timeFrame: 1 year
measure: Outcomes of the questionnaire survey 3/5
timeFrame: 1 year
measure: Outcomes of the questionnaire survey 4/5
timeFrame: 1 year
measure: Outcomes of the questionnaire survey 5/5
timeFrame: 1 year
measure: NCD Screening study 1/11
timeFrame: 1 year
measure: NCD Screening study 2/11
timeFrame: 1 year
measure: NCD Screening study 3/11
timeFrame: 1 year
measure: NCD Screening study 4/11
timeFrame: 1 year
measure: NCD Screening study 5/11
timeFrame: 1 year
measure: NCD Screening study 6/11
timeFrame: 1 year
measure: NCD Screening study 7/11
timeFrame: 1 year
measure: NCD Screening study 8/11
timeFrame: 1 year
measure: NCD Screening study 9/11
timeFrame: 1 year
measure: NCD Screening study 10/11
timeFrame: 1 year
measure: NCD Screening study 11/11
timeFrame: 1 year
Secondary outcomes:
measure: effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis
timeFrame: 1 year
Other outcomes:
Locations:
city: Udaipur
country: India
facility: GBH Cancer Memorial Hospital
state: Rajasthan
Study officials:
References:
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.
citation: 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.