| CTRI Number |
CTRI/2024/08/072366 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Self-help group-based awareness campaign (SHGBAC)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare the effects of self-help group-based awareness campaign and contemporary awareness through ASHA health worker on detection of cancer of female reproductive tract among rural women. |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of a self-help group-based awareness campaign (SHGBAC) as against contemporary awareness through ASHA health worker in respect to screening of cervical cancer among rural women.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Achita Sawarkar |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Health Nursing, Smt. Radhikabai Meghe Memorial College Of Nursing,
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8421621140 |
| Fax |
|
| Email |
achitasawarkar5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
Associate Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Health Nursing, Smt. Radhikabai Meghe Memorial College Of Nursing,
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9527538397 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
Associate Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Health Nursing, Smt. Radhikabai Meghe Memorial College Of Nursing,
Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
9527538397 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha India 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Achita Sawarkar |
Datta Meghe Institute of Higher Education and Research |
Department of Community Health Nursing
Smt. RadhikabaiMeghe Memorial College Of Nursing, Sawangi Meghe Wardha India 442001
Wardha
MAHARASHTRA |
8421621140
achitasawarkar5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Self-help group-based awareness campaign (SHGBAC) on Cervical cancer |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Awareness through ASHA health worker |
ASHA workers will spread awareness on cervical cancer screening among rural women for a period of 1 month. |
| Intervention |
Self-help group-based awareness campaign (SHGBAC) |
Self-help group-based awareness campaign (SHGBAC) will be implemented for 1 month regarding screening of cervical cancer among rural women. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Rural women in the age group of 21 years and above.
2. Rural woman who understand Marathi
3. Rural woman who are willing to participate in study
|
|
| ExclusionCriteria |
| Details |
1. Rural woman with severe physical and mental disorders
2. Rural woman involved in other similar research projects.
3. Health professionals. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved number for cervical cancer screening,
Early diagnosis of cervical cancer, Treatment initiation among diagnosed rural women
|
Assessment will be done at 1 month, 3 months and 6 months from enrolment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
study is a randomized trial comparative
efficacy of a self-help group-based awareness campaign (SHGBAC) as against
contemporary awareness through ASHA health workers with respect to screening of
cervical cancer among rural women.
The outcomes that will be studied include Improved number
for cervical cancer screening, Early diagnosis
of cervical cancer, Treatment
initiation among diagnosed rural women |