| CTRI Number |
CTRI/2024/12/078501 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Structured Teaching Programme] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Enhancing Knowledge of Endometrial Cancer Prevention: The Impact of a Structured Teaching Program on Middle-Aged Women |
|
Scientific Title of Study
|
Assess the effectiveness of structured teaching programme on the knowledge regarding endometrial cancer and its prevention among middle adulthood 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 |
Lalhmachhuani Hmar |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Medical Surgical Nursing, S.R.M.M.C.O.N Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9615849121 |
| Fax |
|
| Email |
teihmar49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchira Ankar |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Medical Surgical Nursing, S.R.M.M.C.O.N Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7620978673 |
| Fax |
|
| Email |
ruchira3110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchira Ankar |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Medical Surgical Nursing, S.R.M.M.C.O.N Building, Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
7620978673 |
| Fax |
|
| Email |
ruchira3110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe Wardha Inia 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha Inia 442001 |
| Type of Sponsor |
Government 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 |
| Dr Lalhmachhuani Hmar |
Acharya Vinoba Bhave Rural Hospital |
Dept. of Obstetrics and Gynaecology,2nd floor, AVBRH Building, Sawangi, Meghe
Wardha
MAHARASHTRA |
9615849121
teihmar49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIl |
NA |
| Intervention |
Structured Teaching Programme |
Pre-test questionnaire will be distributed among the women, after that structured teaching programme on endometrial cancer and its prevention will be delivered. Post test questionnaire will be distributed and the result will be analysed. The period of intervention will be 3 to 6 hours. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Middle adulthood who are willing to participate, middle adulthood who are in a specified age range 35 to 60 years, middle adulthood who are available during data collection, Middle adulthood who can read, write and understand Marathi.
|
|
| ExclusionCriteria |
| Details |
Middle adulthood who had attend similar programme before 6 months, woman who are not in age group 35 to 65 years of age.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in knowledge regarding endometrial cancer and its prevention |
Assessment will be done at the end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/01/2025 |
| 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="1"
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
Modification(s)
|
Introduction: Endometrial cancer is the most common gynaecological malignancy in the whole world. Epidemiological studies have widely documented the association of endometrial cancer with modifiable lifestyle risk factors, most notably obesity. However, preventative strategies for endometrial cancer have not been well reported. The recent findings were, Obesity is an established risk factor for endometrial cancer. Weight cycling and weight gain in middle age are risk factors for endometrial cancer. Methodology: Pre-test structured knowledge questionnaire will be administered about knowledge regarding endometrial cancer and its prevention. After the answers will be enquired, structured teaching was carried out about knowledge regarding endometrial cancer and its prevention. The post- test will be conducted with same structured knowledge questionnaire. After this analysis will be done and result will be interpreted. Expected outcome: Improvement in the knowledge regarding endometrial cancer and its prevention among middle adulthood women. |