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Effectiveness of a Cervical Cancer Stigma Reduction Intervention Program on Cancer Stigma Score and Cervical Cancer Screening Uptake in Nepal

Primary Purpose

Cervical Cancer, Stigma, Screening

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
"Cervical Cancer Stigma Reduction Intervention"
Sponsored by
Kathmandu University School of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women aged 30-60 years (the age range recommended for VIA screening in Nepal
  • Married women
  • Residents of Budanilkantha Municipality

Exclusion Criteria:

  • Women who have already undergone screening within 5 years.
  • Women with hearing or mental disorders
  • Pregnant women
  • Less than 6 weeks postpartum
  • Mothers who had lived in the community for less than 6 months to perform seasonal work (e.g. in brick kilns) or visitors in the family.
  • Women who are already diagnosed with cervical pre-cancer and cancer and have undergone hysterectomy.

Sites / Locations

  • Budanilkantha Municipality

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

Randomization will allocate women to intervention and control arm in 1:1 ratio; with 6 wards in each group. The intervention arm will consist of 153 women who will receive "Cervical Cancer Stigma Reduction Intervention".

The control arm will consist of 153 women who would not be given any intervention.

Outcomes

Primary Outcome Measures

Mean stigma score
Change in mean stigma score using Cancer Stigma Scale at baseline and follow up

Secondary Outcome Measures

Cervical cancer screening uptake
Number of women attending cervical cancer screening program in intervention and control groups

Full Information

First Posted
May 24, 2022
Last Updated
April 18, 2023
Sponsor
Kathmandu University School of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05489978
Brief Title
Effectiveness of a Cervical Cancer Stigma Reduction Intervention Program on Cancer Stigma Score and Cervical Cancer Screening Uptake in Nepal
Official Title
Effectiveness of a Cervical Cancer Stigma Reduction Intervention Program on Cancer Stigma Score and Cervical Cancer Screening Uptake in Nepal- A Cluster Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
February 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kathmandu University School of Medical Sciences

4. Oversight

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

5. Study Description

Brief Summary
It is a cluster randomized control trial to assess the effectiveness of the cervical cancer stigma reduction intervention on cancer stigma score and cervical cancer screening uptake in Nepal
Detailed Description
Despite the presence of ample evidence, that stigma is one of the major reasons for low screening coverage, Nepal does not have a single stigma reduction intervention targeted among women to increase cervical cancer screening coverage. Therefore, we aim to assess the effectiveness of a stigma reduction education program on stigma score and cervical cancer screening uptake in Nepal. We will conduct a two-arm open-label cluster-interventional study in Budanilkhantha Municipality. A computer-based program will randomly allocate the 12 wards of Budanilkhantha Municipality with an allocation ratio 1:1; 6 wards in intervention group and 6 wards in control group. We will conduct a "stigma reduction education program" in the intervention group. After that we will follow up the participants for2 months to see the effectiveness of a stigma reduction education program on stigma score and cervical cancer screening uptake in Nepal. We will analyze data using STATA 14. We will use independent tests to find the mean difference between cervical cancer screening uptake and cervical cancer stigma score. The difference in mean among the two groups will actually be the difference due to intervention given. Findings from this study will help managers and stakeholders to formulate and improve strategies on screening programs and develop programs to reduce stigma on cervical cancer among women in Nepal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Stigma, Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Randomization will allocate women to intervention and control arm in 1:1 ratio; with 6 wards in each group. The intervention arm will consist of 153 women who will receive "Cervical Cancer Stigma Reduction Intervention".
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
The control arm will consist of 153 women who would not be given any intervention.
Intervention Type
Behavioral
Intervention Name(s)
"Cervical Cancer Stigma Reduction Intervention"
Intervention Description
Change in knowledge: Cervical cancer burden in Nepal, signs and symptoms, preventive measures available, lifestyle modifications, HPV vaccination, early diagnosis, screening, and treatment. Change in Stigma Para-social contact Video of a person facing cervical cancer what symptoms she got, how she dealt with it, and how she overcame it. Experiences of a cervical cancer survivor so that women personalize the information by relating it to their own life experiences by changing their attitude and behavior. Participatory learning techniques Personal stories: Voluntary self-reflection of any stigma they perceive on cervical cancer or their community perceives cervical cancer. Group Discussion: Discuss the drivers of stigma, facilitators of sigma, types of stigma prevalent in your community, and consequences of stigma. Myths vs facts: Negative attitudes, myths, and misconceptions about cervical cancer will be contraindicated by factual information.
Primary Outcome Measure Information:
Title
Mean stigma score
Description
Change in mean stigma score using Cancer Stigma Scale at baseline and follow up
Time Frame
Measured at baseline and endline (after 2 months gap from baseline)
Secondary Outcome Measure Information:
Title
Cervical cancer screening uptake
Description
Number of women attending cervical cancer screening program in intervention and control groups
Time Frame
Measured within a month after endline

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study population will be women aged 30-60 years which is the recommended age group by National Guideline for Cervical Cancer Screening and Prevention in Nepal
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women aged 30-60 years (the age range recommended for VIA screening in Nepal Married women Residents of Budanilkantha Municipality Exclusion Criteria: Women who have already undergone screening within 5 years. Women with hearing or mental disorders Pregnant women Less than 6 weeks postpartum Mothers who had lived in the community for less than 6 months to perform seasonal work (e.g. in brick kilns) or visitors in the family. Women who are already diagnosed with cervical pre-cancer and cancer and have undergone hysterectomy.
Facility Information:
Facility Name
Budanilkantha Municipality
City
Kathmandu
State/Province
Province-3
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of a Cervical Cancer Stigma Reduction Intervention Program on Cancer Stigma Score and Cervical Cancer Screening Uptake in Nepal

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