CTRI

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CTRI Number

CTRI/2023/07/055476 [Registered on: 21/07/2023] Trial Registered Prospectively

Last Modified On:

22/07/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Preventive
Behavioral
Other (Specify) [Knowledge]

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A study to assess effect of teaching on knowledge, attitude, and skill regarding Breast Cancer and its preventive measures.

Scientific Title of Study

Randomized Control Trial to evaluate the Effectiveness of Community-Based Educational Intervention (CBEI) on knowledge, attitude, and skill regarding Breast Cancer and its preventive measures among rural women of Hoshiarpur, Punjab.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
Nil	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Renuka Sandhu
Designation	Ph D Nursing Scholar
Affiliation	Desh Bhagat University,Mandi Gobindgarh
Address	R.No. 06,Research Cell, Nursing Department, Desh Bhagat University, Amloh Road, Mandi Gobindgarh, District Fatehgarh Sahib Fatehgarh Sahib PUNJAB 147301 India
Phone	7837012416
Fax
Email	rtsandhu88@gmail.com

Details of Contact Person
Scientific Query

Name	Dr N Balasubramanian
Designation	Director-Principal
Affiliation	Desh Bhagat University, Mandi Gobindgarh
Address	Director-Principal office, Nursing Department, SLM Institute of Nursing, A division of Desh Bhagat University, Amloh Road, Mandi Gobindgarh Punjab Fatehgarh Sahib PUNJAB 147301 India
Phone	8427309077
Fax
Email	snbalu78@gmail.com

Details of Contact Person
Public Query

Name	Dr N Balasubramanian
Designation	Director-Principal
Affiliation	Desh Bhagat University, Mandi Gobindgarh
Address	Director-Principal office, Nursing Department, SLM Institute of Nursing, A division of Desh Bhagat University, Amloh Road, Mandi Gobindgarh Punjab Fatehgarh Sahib PUNJAB 147301 India
Phone	8427309077
Fax
Email	snbalu78@gmail.com

Source of Monetary or Material Support

Desh Bhagat University, Mandi Gobindgarh

Primary Sponsor

Name	Renuka Sandhu
Address	Desh Bhagat University, Mandi Gobindgarh Punjab
Type of Sponsor	Other [self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Renuka Sandhu	Desh Bhagat University	R.No. 06,Research Cell, Nursing Department, Desh Bhagat University, Amloh Road, Mandi Gobindgarh, District Fatehgarh Sahib. Fatehgarh Sahib PUNJAB	7837012416 rtsandhu88@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Desh Bhagat University Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Women who are not having physical and psychological problems,not pregnant during study period and women who are not diagnosed with breast cancer.

Intervention / Comparator Agent

Type	Name	Details
Intervention	Community-Based Educational Intervention	The intervention comprises educational packages delivered for a period of 2 months with an interval of 21 days for each session. Community-Based educational packages consist of flashcards, PowerPoints presentation, group discussions, and demonstrations on breast cancer and its preventive measures. It was assured that teaching is interesting and effective. Since this study will not involve any medical treatment, so details on drugs, dose, duration, frequency, and route of administration are not applicable.
Comparator Agent	Non Intervention	The educational package related to breast cancer and its preventive measures will not be delivered to this group.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	55.00 Year(s)
Gender	Female
Details	1. Women who are in age group 18 - 55 years. 2. women who are residing in selected villages of district Hoshiarpur. 3. Women who are willing to participate in study group. 4. Women who are able to read and understand Punjabi language.

ExclusionCriteria

Details

1. Women who are having physical and psychological problems.
2. Women who are pregnant during study period.
3. Women who are diagnosed with breast cancer.

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
1. Enhance in Knowledge score related to breast cancer & preventive measures. 2. Increase in positive attitude related to breast cancer & preventive measures. 3. Improve skills related to breast cancer & preventive measures.	Baseline assessment on 1st day, Follow up Assessment on 21 day, 42 and 62 day.

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="400"

Phase of Trial

N/A

Date of First Enrollment (India)

28/07/2023

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="3"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

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

In light of past research and personal experience in the field of community, it has been observed that women have a lack of knowledge, negative attitudes and poor or no skills toward breast cancer and its preventive measures. So, more research is needed to determine that a community-based teaching program will be an effective technique for enhancing knowledge, bringing a positive attitude, and increasing skills towards breast cancer and its preventive measures.