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Cervical Cancer Screening : Video Based Tutorials for ANMs/ASHAs/PHWs

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
cervical cancer screening
Sponsored by
Tata Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring VIA, Cervical Cancer, Training

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: ANMs /ASHAs/PHWs attached to the TMC, District Hospitals and PHCs who have not learned VIA based cervical cancer screening before.

Exclusion Criteria: ANMs /ASHAs/PHWs attached to the TMC, District Hospitals and PHCs who have learnt VIA based cervical cancer screening before.

Sites / Locations

  • Tata Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

cervical cancer

Arm Description

cervical cancer screening and training for ANMs/ASHAs/PHWs To develop video-based tutorials to train ANMs/ASHAs/PHWs in conducting cervical cancer related health education, screening for cervical cancers using VIA, collection of PAP smears and HPV samples.

Outcomes

Primary Outcome Measures

Improvement in the Post training knowledge about cancer
Questionnaire: that will compare pre-training knowledge with post training and assess the improvement in the Post training knowledge about various aspects of cervical cancer viz., causes, various cervical cancer screening techniques, steps required to perform VIA etc. These will be measured with the help of test scores. Each question in the test will have marks assigned to it based on difficulty level. (Easy 1 mark, Intermediate 2 marks, Hard 3 marks, Very hard 4 marks). The ANMs will be assigned marks depending on the number of correct responses. The ANMs will have to take the tests before the training, immediately after the training, and three months after the training is complete.

Secondary Outcome Measures

Satisfaction to the video based tutorials
Questionnaire: that will assess the satisfaction level and feed back of the trainees with the course provided. The satisfaction level with the mode of teaching will be done on a survey based on a likert scale.

Full Information

First Posted
May 16, 2016
Last Updated
August 3, 2018
Sponsor
Tata Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02783235
Brief Title
Cervical Cancer Screening : Video Based Tutorials for ANMs/ASHAs/PHWs
Official Title
Cervical Cancer Screening: Video-based Tutorials for Skills Development of ANMs/ASHAs/PHWs
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 29, 2018 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tata Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims at creating video-based tutorials for developing skills in performing cervical cancer screening using VIA for the Auxillary Nurse Midwives (ANMs), Accredited Social Health Activists (ASHAs) and Primary Health Workers (PHWs). Cervical cancer screening is mainly done by the following three methods: Visual inspection with acetic acid (VIA), Cervical Smear Cytology (PAP) and HPV DNA test. VIA is a low cost, low resource cervical cancer screening method and especially useful for low middle income countries (LMICs) like India. We propose to develop video-based tutorials, such that the ANMs/ASHAs/PHWs could be trained in performing and interpreting VIA with the use of this tutorial. The ANMs/ASHAs/PHWs have important roles in delivering health in rural/ semi urban areas and they will be trained using this tutorial. The video-based tutorials will be made according to the 'Spoken Tutorials' methodology, developed at IIT Bombay. Video-based Tutorials has given skills based training to over 2 lakh students in the past four years on IT based topics. The tutorials are made available online free of cost. They are designed to be used without the need of an expert being physically present.
Detailed Description
Aim of the study: To develop video-based tutorials to train ANMs/ASHAs/PHWs in conducting cervical cancer related health education, screening for cervical cancers using VIA, collection of PAP smears and HPV samples. To reduce the training time required by an expert to train ANMs/ASHA/PHWs as compared to the traditional training methods. To evaluate the efficacy of the training tool by conducting a pre-test and post-test and practical test for lesion identification. To assess the satisfaction levels of ANMs/ASHAs/PHWs for learning through video-based tutorials. Methodology: A. Creating the Tutorials 1) The video-based tutorials will be created with the help of domain experts, Content generators and Animators. B. Conducting the Training TMH will recruit Medical Social Workers and Health Workers to provide training to 50 ANMs/ASHAs/PHWs at their own centres. The training will be staggered into different modules, and will be completed for each trainee over a period of approximately 3 months. The investigators will also obtain images after due permissions, of the clinic, preparations for examination like arrangements of trolleys, preparation of dilute acetic acid, etc. and the cervical pictures/ videos of the patients before and after VIA after obtaining due consents (there will be no revealing of identity) to aid the animation and the tutorials. The effectiveness of the tutorials will be checked by a pre- and post- tutorial assessment quiz. Sample Size and power estimates: For this study, sampling method is a convenience sample of 50 ANMs/ASHAs/PHWs attached to the TMC, District, Municipal Hospitals and PHCs who have not learned VIA based cervical cancer screening before. Three MSWs will be appointed to co-ordinate with the respective officials of BMC, State Government, District hospitals etc. and explain the importance of the project. The Social Workers will approach different BMC hospitals in Mumbai and PHCs and district hospitals around Mumbai to relieve their ANMs/ASHAs/PHWs to participate in this training. Newly recruited PHWs in the Preventive Oncology projects will also be enrolled for this training. Pre training knowledge about various aspects of cervical cancer viz., causes, various cervical cancer screening techniques, steps required to perform VIA etc. The satisfaction level and feed back of the trainees with the course provided. Improvement in the Post training knowledge about various aspects of cervical cancer viz., causes, various cervical cancer screening techniques, steps required to perform VIA etc. These will be measured with the help of test scores. Each question in the test will have marks assigned to it based on difficulty level. (Easy 1 mark, Intermediate 2 marks, Hard 3 marks, Very hard 4 marks). The ANMs will be assigned marks depending on the number of correct responses. The ANMs will have to take the tests before the training, immediately after the training, and three months after the training is complete. The satisfaction level with the mode of teaching will be done on a survey based on a likert scale. Ability to correctly identify a VIA positive lesion. This will be measured based on marks they score during the tests and assignments, where they will do an image based diagnosis of 15 VIA cases. This will also be scored based on observation sessions they will have with a doctor who performs VIA on 10 patients. They will be assessed based on the number of correct identifications of VIA lesions. Data entry and analysis: Data entry will be done in IIT Bombay and in the Department of Preventive Oncology, Tata Memorial Hospital, using SPSS version 18. Checks for consistency, data safety and analysis will be carried out at regular intervals. Both descriptive and inferential statistics will be generated for describing variables under the study objectives. Agreement of test scores, pre-training and post-training will be estimated using kappa statistics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
VIA, Cervical Cancer, Training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cervical cancer
Arm Type
Other
Arm Description
cervical cancer screening and training for ANMs/ASHAs/PHWs To develop video-based tutorials to train ANMs/ASHAs/PHWs in conducting cervical cancer related health education, screening for cervical cancers using VIA, collection of PAP smears and HPV samples.
Intervention Type
Other
Intervention Name(s)
cervical cancer screening
Intervention Description
for 50 ANMs/ASHAs/PHWs/ in conducting cervical cancer related health education , screening for cervical cancers using VIA, collection of PAP smears and HPV samples.
Primary Outcome Measure Information:
Title
Improvement in the Post training knowledge about cancer
Description
Questionnaire: that will compare pre-training knowledge with post training and assess the improvement in the Post training knowledge about various aspects of cervical cancer viz., causes, various cervical cancer screening techniques, steps required to perform VIA etc. These will be measured with the help of test scores. Each question in the test will have marks assigned to it based on difficulty level. (Easy 1 mark, Intermediate 2 marks, Hard 3 marks, Very hard 4 marks). The ANMs will be assigned marks depending on the number of correct responses. The ANMs will have to take the tests before the training, immediately after the training, and three months after the training is complete.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Satisfaction to the video based tutorials
Description
Questionnaire: that will assess the satisfaction level and feed back of the trainees with the course provided. The satisfaction level with the mode of teaching will be done on a survey based on a likert scale.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Clinical skills development
Description
Scores will be assigned and the ability to correctly identify a VIA positive lesion will be assessed.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ANMs /ASHAs/PHWs attached to the TMC, District Hospitals and PHCs who have not learned VIA based cervical cancer screening before. Exclusion Criteria: ANMs /ASHAs/PHWs attached to the TMC, District Hospitals and PHCs who have learnt VIA based cervical cancer screening before.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gauravi A Mishra, MD
Phone
+912224177000
Ext
4634
Email
gauravi2005@yahoo.co.in
First Name & Middle Initial & Last Name or Official Title & Degree
Sharmila A Pimple, MD
Phone
+912224177000
Ext
4631
Email
pimplesharmila@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gauravi A Mishra, MD
Organizational Affiliation
Tata Memorial Hospital, Mumbai.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gauravi A Mishra, MD
Organizational Affiliation
ata Memorial Hospital, Mumbai.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gauravi A Mishra, MD
Phone
+912224177000
Ext
4634
Email
gauravi2005@yahoo.co.in

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data entry will be done in IIT Bombay and in the Department of Preventive Oncology, Tata Memorial Hospital, using SPSS version 18.

Learn more about this trial

Cervical Cancer Screening : Video Based Tutorials for ANMs/ASHAs/PHWs

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