Genetic testing for breast and ovarian cancer amongst black African women in Luton (UK)
| ISRCTN | ISRCTN62028038 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62028038 |
- Submission date
- 27/03/2021
- Registration date
- 30/03/2021
- Last edited
- 30/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and Study aims
Breast cancer has been identified as the most common cancer among women worldwide. Breast cancer accounts for approximately 15% of all new cancer cases in the UK every year. Approximately 54,000 new cases of invasive breast cancer and 700 new cases of pre-invasive breast cancers are diagnosed yearly. Although most breast cancers are diagnosed at an early stage, breast cancer remains the leading cause of death in women aged 35-49. Ovarian cancer accounts for more deaths than other gynaecological malignancies and is the 6th most common cancer amongst women in the UK. With incidence rates higher in women aged 75-79 in 2016, 5% of all cancer-related deaths in the UK were from ovarian cancer. 60% of most ovarian cancers are diagnosed at later stages in the UK compared to other countries. These facts suggest the importance of early diagnosis to improve prospects of long-term survival and decrease the mortality rate of both breast and ovarian cancer.
There are two types of screening used to respectively detect cancers (routine cancer screening) and detect a gene that could cause an individual to be at a higher risk of developing certain types of cancers (genetic testing).
The rationale of this study is based on the lack of research investigating Black African women’s awareness and knowledge of genetic testing and the scarcity of interventions to increase uptake of genetic testing for breast and ovarian cancer in Luton.
Who can participate?
Women self-identifying themselves as Black African women aged 18 - 69 years, residing in Luton with a good understanding and speaking level of English.
What does the study involve?
A "Health Party" intervention conducted virtually via Zoom due to the pandemic restrictions consisting of an educational session in a party setting. Participants were taught about genetic testing and how to access genetic testing services in the NHS by qualified healthcare professionals.
What are the possible benefits and risks of participating?
Benefits include a potential increase in awareness, knowledge and uptake of genetic testing amongst Black African women and help them to make informed choices about genetic testing whilst improving early diagnosis of breast and ovarian cancer.
Risks include the possibility of distress in both the participants and facilitators due to the topic discussed. The researcher used a distressed protocol in place to identify signs of distress amongst the participants and facilitators.
Where is the study run from?
University of Bedfordshire (UK)
When is the study starting and how long is it expected to run for?
August 2020 to May 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Valencia Kabeya, valencia.kabeya@study.beds.ac.uk
Contact information
Public
University of Bedfordshire
Room 32
Putteridge Bury campus
Hitchin Road
Luton
LU2 8LE
United Kingdom
 ORCID ID |
0000-0001-6194-7095 |
|---|---|
| Phone | +44 (0)1582 743797 |
| valencia.kabeya@study.beds.ac.uk |
Study information
| Study design | Quasi-experimental feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Quasi-experimental |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | A “Health Party” intervention on genetic testing for breast and ovarian cancer amongst black African women in Luton (UK): feasibility study protocol |
| Study objectives | A "Health Party" intervention aiming to increase knowledge, awareness and uptake of genetic testing for breast and ovarian cancer amongst Black African women in Luton. |
| Ethics approval(s) | Approved 13/08/2020, Institute for Health Research (IHR) Ethics Committee at the University of Bedfordshire (Room 120, Putteridge Bury, Luton, Bedfordshire, LU2 8LE, UK; +44 (0)1582 743797; gurch.randhawa@beds.ac.uk), ref: IHREC947 |
| Health condition(s) or problem(s) studied | Genetic testing for breast and ovarian cancer |
| Intervention | The “Health Party” intervention consists of an educational session in a party session that was performed virtually via zoom due to the pandemic restrictions. Participants were taught about genetic testing and how to access genetic testing services in the NHS by qualified healthcare professionals. 5 virtual sessions were conducted each with about 10-12 participants. A quantitative pre-post evaluation with measurements prior, at 2 - 3hrs and at 6 months following the intervention were conducted to assess the preliminary effectiveness on knowledge, awareness and uptake of genetic testing. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Feasibility by assessing the recruitment and retention rate. Descriptive statistics were used to assess the participant’s uptake rate (recruitment rate) and participant’s retention over the period of the intervention by recording the participants filling the 2-3hour post-intervention form and the 6 month follow up form (retention rate). The recruitment rate was assessed by tracking the number of potential participants who confirmed their attendance to the heath party that attended and those that did not attend. The retention rate was assessed by tracking the number of participants who took part in all the requirements of the intervention. This included how many participants filled the 2-3 hour post-intervention form and the 6 month follow up form. The 6 month follow up is yet to be conducted. 2. Acceptability by conducting focus groups discussions amongst the participants and the facilitators to provide insight in their experience of the intervention. The data gathered was analysed thematically with the use of the Nvivo 10 software using the thematic analysis approach. Acceptability of the intervention was also assessed quantitatively using the SPSS version 24 to assess the scores obtained by both the participants and facilitators through a survey. 3. The fidelity of training, delivery and receipt were assessed in this intervention. 3.1. Fidelity of training was assessed qualitatively in the focus group discussions conducted by the researcher with the facilitators. A survey was also given to the facilitators to evaluate fidelity of training and was measured quantitatively. 3.2. Fidelity of delivery. The researcher tailored a checklist of the components of the educational content of the interventions to assess fidelity of delivery . The researcher conducted this assessment during the presentation of the educational content. Each session was audio-recorded to ensure that this assessment was accurate. This was measured by calculating the difference between the content covered and the intended content 3.3. Fidelity of receipt was assessed qualitatively during the focus group discussions with the participants and quantitatively through a survey sent to the participants after the intervention |
| Secondary outcome measures | 1. Participants’ knowledge, awareness, and uptake of genetic testing measured using a questionnaire at baseline, 2 - 3 hours post-intervention, and 6 month follow up |
| Overall study start date | 13/08/2020 |
| Completion date | 03/05/2021 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Mixed |
| Sex | Female |
| Target number of participants | 50 |
| Total final enrolment | 54 |
| Key inclusion criteria | 1. Black African women aged 18 - 69 years 2. Residing in Luton 3. Good understanding and speaking level of English |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/09/2020 |
| Date of final enrolment | 26/10/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Luton
LU2 8LE
United Kingdom
Sponsor information
University/education
Vicarage Street
3788 University Drive
Luton
LU1 3JU
England
United Kingdom
| shuby.puthussery@beds.ac.uk | |
| Website | http://www.beds.ac.uk/ |
"ROR" |
https://ror.org/0400avk24 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/05/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository. |
Editorial Notes
30/03/2021: Trial's existence confirmed by University of Bedfordshire
