Impact of health education intervention on cervical cancer and screening for women in Ghana
| ISRCTN | ISRCTN13468198 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13468198 |
| Secondary identifying numbers | DRIC/UCC/18 |
- Submission date
- 18/03/2019
- Registration date
- 22/03/2019
- Last edited
- 15/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
School of Nursing and Midwifery
University of Cape Coast
Cape Coast
-
Ghana
 ORCID ID |
0000-0002-3279-5800 |
|---|---|
| Phone | +233 (0)541145193 |
| nebu@ucc.edu.gh |
Study information
| Study design | Non-equivalent control-group design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Scientific title | Impact of health education intervention on cervical cancer and screening for women in Ghana: a community-based trial |
| Study acronym | IHEICCSWG |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 08/08/2017 |
| Completion date | 07/11/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Other |
| Sex | Female |
| Target number of participants | 418 women were recruited for the intervention group and another 418 for the control group |
| Total final enrolment | 782 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 07/08/2018 |
| Date of final enrolment | 30/08/2018 |
Locations
Countries of recruitment
- Ghana
Study participating centre
University of Cape Coast
Cape Coast
-
Ghana
Sponsor information
Government
University of Cape Coast
Cape Coast
-
Ghana
| Phone | +233 (03321) 32480/32483 |
|---|---|
| registrar@ucc.edu.gh | |
| Website | www.ucc.edu.gh |
"ROR" |
https://ror.org/0492nfe34 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 08/10/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/11/2019 | 15/11/2019 | Yes | No |
Editorial Notes
15/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
22/03/2019: Trial's existence confirmed by the funding agency and institutional review board.
