Protocol summary

Study aim
The aim of the study is the use of the theory of planned behavior in prevention, promotion and maintenance of behaviors for cervical cancer prevention in rural areas after identification of women with poor knowledge, attitude and perception regarding cervical cancer and designing and implementing behavior modification educational strategies. Study also aims to measure the uptake of pap smear screening among intervention group and results will be shared with health care system in order to take appropriate action for cervical cancer prevention in rural areas of Pakistan.
Design
Randomised controlled trial consisting of two groups; Intervention and control group consisting of 145 sample in each group. Eligible women will be selected through simple random sampling.
Settings and conduct
Settings will be rural areas of Punjab. Pre-test will be done on a structured questionnaire and health education will be given to intervention group and finally post test will be conducted to measure the effectiveness.
Participants/Inclusion and exclusion criteria
Married females of 15-70 years, no prior hysterectomy and pap smear test. Women who already diagnosed with any type of cancer or with any other health condition will be excluded.
Intervention groups
Educational interventions will be given to intervention group. There will be lecture method and a video will be shown to the participants consisting of information regarding cervical cancer prevention.
Main outcome variables
Preventive behaviors and screening of cervical cancer.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200408046998N1
Registration date: 2020-12-30, 1399/10/10
Registration timing: retrospective

Last update: 2020-12-30, 1399/10/10
Update count: 0
Registration date
2020-12-30, 1399/10/10
Registrant information
Name
Farzana Iqbal
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 32182632
Email address
farzana.iqbal@live.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-20, 1399/06/30
Expected recruitment end date
2020-12-15, 1399/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of Health Education on Knowledge, Attitude and Perception Regarding Cervical Cancer and Screening Uptake among Women in Rural Areas of Punjab, Pakistan
Public title
Evaluate the effect of Health Education on Knowledge, Attitude and Perception Regarding Cervical Cancer and its Screening among Women of Rural Areas of Punjab
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married, age from 15-70 years and they are willing to participate in the study. Women of rural community No prior hysterectomy No pap smear test within last three year
Exclusion criteria:
Already diagnosed with any type of cancer Any family member diagnosed with cancer All the woman who will be pregnant, hospitalized or diagnosed with any critical health situation HIV positive or on immunosuppressive treatments All those who refused to participate in this study
Age
From 15 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 290
Randomization (investigator's opinion)
Randomized
Randomization description
Two districts of Punjab will be randomly selected on the basis of high literacy and low literacy rate. At first stage, the list of the tehsils will be prepared for all the rural areas of selected districts and then one tehsil will be selected through simple random sampling. Moreover, in next stage, a list will be prepared for all the union councils of selected tehsils. Then, 1/4th union councils will be selected through lottery method. One participant will be selected per house using simple random sampling by balloting from selected union councils. Eligible women will be divided equally in Intervention and control groups by using table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of The University of Lahore
Street address
1 - KM Defence Road, Lahore
City
Lahore
Postal code
54000
Approval date
2020-03-02, 1398/12/12
Ethics committee reference number
IRB-UOL-FAHS/716/2020

Health conditions studied

1

Description of health condition studied
Cervical Cancer Prevention
ICD-10 code
D06
ICD-10 code description
Carcinoma in situ of cervix uteri

2

Description of health condition studied
Cervix Cancer Screening
ICD-10 code
Z01.4
ICD-10 code description
Encounter for gynecological examination

Primary outcomes

1

Description
Cervical cancer prevention
Timepoint
Before and after eight weeks of intervention
Method of measurement
Measurement will be done by using a questionnaire consisting of demographic variables, knowledge, attitude and perception variables

2

Description
Cervical Cancer Screening (Pap Smear)
Timepoint
Before and after 8 weeks of intervention
Method of measurement
By performing pap smear test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A structured health education will be given to the intervention group respondents about cervical cancer awareness and its screening. There will be lecture method and a video will be shown to the participants. Education material will consist of: what is cervical cancer its sign symptoms and risk factors? How is HPV transmitted? HPV screening and prevention methods, what increases or decreases the risk of developing cervical cancer, what is a Pap test and how to schedule a Pap test and follow up on the results, and what does an abnormal Pap test result mean. The women will be educated in batches (29) each. Each batch will be trained for one day over a 2 hour period from 1000 to 1200 hours. Health Education sessions will last for 5 days.
Category
Prevention

2

Description
Control group: The control group will receive usual care. This group also receive health education on cervical cancer and its screening after post intervention activities.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Chief Executive Officer, District Health Authority, Sheikhupura
Full name of responsible person
Dr Saddique Ahmad
Street address
Lahore-Sargodha Rd, Nabipura, Civil Lines, Sheikhupura, Punjab
City
Sheikhupura
Postal code
39350
Phone
+92 56 3810303
Email
dhis.skp@gmail.com

2

Recruitment center
Name of recruitment center
Chief Executive Officer, District Health Authority, Muzaffargarh
Full name of responsible person
Dr Faiz Kareem
Street address
Near Yadgar Chowk Alipur Road, Muzaffargarh, Punjab
City
Muzaffargarh
Postal code
34200
Phone
+92 66 9200236
Email
edohealth.mfg@punjab.gov.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty of Allied Health Sciences, The University of Lahore
Full name of responsible person
Prof. Dr. Saleem Rana
Street address
1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road, Lahore.
City
Lahore
Postal code
54000
Phone
+92 42 35322501
Email
smrmep@gmail.com
Web page address
https://www.uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Allied Health Sciences, The University of Lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Farzana Iqbal
Position
PhD Scholar
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
House No 65, C Block- Valencia Town Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 32182632
Email
farzana.iqbal@live.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Prof. Dr. M Saleem Rana
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health
Street address
1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road, Lahore.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35321761
Email
smrmep@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Farzana Iqbal
Position
PhD Scholar
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
House No 65 C Black Valencia Town Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 32182632
Email
farzana.iqbal@live.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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