Condition category
Cancer
Date applied
18/03/2019
Date assigned
22/03/2019
Last edited
22/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cervical cancer is a leading cause of death among women. However, it is preventable, as there are technologies for early detection and treatment of precancerous lesions. The main aim of this study is to determine the effect of a health education intervention on cervical cancer and screening beliefs and perceptions of women in the Komenda, Edina, Eguafo, and Abirem District in the Central Region.

Who can participate?
Women aged 11 to 70 at selected churches in Elmina and Kissi in the Central Region of Ghana

What does the study involve?
The study will involve women in Elmina and Kissi completing questionnaires on cervical cancer and screening after which health education on cervical cancer and screening is offered to women in Elmina only for six weeks and data is collected again from both groups.

What are the possible benefits and risks of participating?
Women will receive information on cervical cancer and screening. Those in the intervention group will benefit from health education on cervical cancer and screening, which can enable them to adopt behaviours to prevent cervical cancer. The study will not result in any physical, social or psychological risks, but participants are being cautioned that some of the questions may cause emotional discomfort.

Where is the study run from?
University of Cape Coast (Ghana)

When is the study starting and how long is it expected to run for?
August 2017 to November 2018

Who is funding the study?
Directorate of Research, Innovation and Consultancy of the University of Cape Coast (Ghana)

Who is the main contact?
Dr Nancy Innocentia Ebu Enyan
nebu@ucc.edu.gh

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nancy Innocentia Ebu

ORCID ID

http://orcid.org/0000-0002-3279-5800

Contact details

School of Nursing and Midwifery
University of Cape Coast
Cape Coast
-
Ghana
+233 (0)541145193
nebu@ucc.edu.gh

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

DRIC/UCC/18

Study information

Scientific title

Impact of health education intervention on cervical cancer and screening for women in Ghana: a community-based trial

Acronym

IHEICCSWG

Study hypothesis

The study hypothesised that there will be an increase in knowledge about cervical cancer, knowledge about cervical cancer screening, perceived susceptibility, perceived seriousness, perceived benefits, and self-efficacy in the intervention group compared to the control group. It also hypothesised that perceived barriers about cervical cancer screening will decrease for women in the intervention group compared to the control group.

Ethics approval

Approved by 08/06/2017, Institutional Review Board of the University of Cape Coast, University of Cape Coast, Institutional Review Board, Private Mail Bag, Cape Coast, Ghana, Tel: +233 (0)558093143/ +233 (0)508878309/ +233 (0)244207814, Email: irb@ucc.edu.gh, ref: UCCIRB/CHAS/2017/24

Study design

Non-equivalent control-group design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Condition

Cervical cancer and screening beliefs and perceptions

Intervention

Six weeks health education was given to women in the selected churches in the intervention group. These women were grouped in their respective churches and baseline data collected before offering the health education on cervical cancer and screening using a standardised tool. The health education intervention took approximately six weeks, variety of teaching methodologies were employed. Also, each participating church had the opportunity of being educated once a week for six weeks. The education was given by a qualified registered nurse, and each session took approximately 1 hour. Participants were reassessed after the intervention

For the control group, initial data was collected from eligible women in the churches constituting the control group who volunteered to participate in the study. Participants from the selected churches were conveniently sampled based on their consent to participate in the study. Data were collected from the same group six weeks after the initial data collection.

Official permission was sought from the leadership of the various churches. Written informed consent was obtained from each participant and with assurance of confidentiality and anonymity. Privacy was also ensured at the data collection stage of the research. Additionally, no personal identifying information was found on the instrument. Persons suspected of having the disease were referred to an obstetrician gynaecologist at the Cape Coast Teaching Hospital for further investigation and management. This intervention would have been expanded to cover all the women in the district, but due to the limited funding available for this project, only the selected women benefited. It is hoped that future interventions would be upscaled to cover other women in the district and beyond.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Knowledge of cervical cancer
2. Knowledge of cervical cancer screening
3. Perceived susceptibility
4. Perceived seriousness
5. Perceived benefits
6. Perceived barriers
7. Self-efficacy
All measured using a questionnaire adapted from Ebu, Mupepi, Siakwa, and Sampselle (2015) and Mupepi, Sampselle and Johnson (2011) at baseline and 6 weeks

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

08/08/2017

Overall trial end date

07/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Women aged 11 to 70 years residing in the K.E.E.A District were included in this study. It was assumed that if women as young as 11 years obtain information about cervical cancer and screening, they will be well informed about the risks and prevention strategies

Participant type

Healthy volunteer

Age group

Other

Gender

Female

Target number of participants

418 women were recruited for the intervention group and another 418 for the control group

Participant exclusion criteria

1. Women who failed to volunteer for the study
2. Those under 11 years and above 70
3. Those with dementia or mental health problems
4. Those who were not residing in the study area

Recruitment start date

07/08/2018

Recruitment end date

30/08/2018

Locations

Countries of recruitment

Ghana

Trial participating centre

Elmina and Kissi in the Central Region of Ghana
School of Nursing and Midwifery University of Cape Coast
Cape Coast
-
Ghana

Sponsor information

Organisation

University of Cape Coast

Sponsor details

University of Cape Coast
Cape Coast
-
Ghana
+233 (03321) 32480/32483
registrar@ucc.edu.gh

Sponsor type

Government

Website

www.ucc.edu.gh

Funders

Funder type

University/education

Funder name

University of Cape Coast

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A manuscript has been prepared for submission to BMC Public Health. The findings will be shared with the participants and stakeholders interested in cervical cancer at the local and international level.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

08/10/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/03/2019: Trial's existence confirmed by the funding agency and institutional review board.