Development of the standardised patient method to assess quality of cancer care in Nigeria and Kenya
| ISRCTN | ISRCTN30416410 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30416410 |
| Sponsor | University of Birmingham |
| Funder | National Institute for Health and Care Research |
- Submission date
- 13/02/2026
- Registration date
- 23/02/2026
- Last edited
- 13/02/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This project is part of a larger programme aiming to shorten the time it takes for people with possible cancer symptoms in sub Saharan Africa to get diagnosed and start treatment. The full programme includes several work packages. The section described here (WP3) focuses on developing and testing a new way to measure how well clinical staff recognise and refer people who have cancer.
To do this, the study will use Standardised Patients (SPs). These are trained individuals who visit health facilities acting as real patients. They follow a set script and then report what happened during the consultation. SPs have been used in many countries, including Kenya and Nigeria, to assess the quality of healthcare, and have featured in major international studies.
The SP method will help identify common gaps to be addressed in clinical practice (including asking history questions, making referrals, requesting lab tests, and dispensing or prescribing medicines) for cancer-related conditions in primary care settings. This information will inform the intervention and function as an outcome measure in evaluation of the intervention.
Who can participate?
For this study, individuals are hired as standardised patients and will present as the patient in the clinical cases they are given.
What does the study involve?
Trained Standardised Patients will visit selected health facilities posing as real patients with scripted symptoms that may indicate cancer. They will undergo a consultation and then record what happened, including whether the health worker recognised the potential seriousness of the symptoms and whether an appropriate referral was made.
No real patients are directly involved, and health workers’ usual practice will not be disrupted.
What are the possible benefits and risks of participating?
Health workers may indirectly benefit from improved training and support developed from the findings of this study, which aims to enhance early cancer detection and referral systems.
The primary risk is minimal and relates to the covert nature of the assessment. However, protections are in place, and the study will only proceed after ethical review and approval.
Where is the study run from?
The study is delivered as part of an international research programme focused on improving cancer outcomes in sub-Saharan Africa. It is sponsored by the University of Birmingham and led co-investigators at the African Population and Health Research Center (Kenya), University of Ibadan (Nigeria) and Bayero University (Kano).
When is the study starting and how long is it expected to run for?
June 2025 to August 2025
Who is funding the study?
The study is funded by the National Institute for Health and Care Research (NIHR) (UK), which has reviewed the scientific quality of the project.
Who is the main contact?
Jen Knight (Project Manager), j.knight.2@bham.ac.uk
Contact information
Principal investigator, Public, Scientific
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 7540 |
|---|---|
| r.j.lilford@bham.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cross sectional study |
| Scientific title | Development of the standardised patient method to assess quality of cancer care in Nigeria and Kenya |
| Study objectives | Develop and test a method to evaluate the quality of diagnosis and referral utilising standardised patients. The standardised patient method will help identify common gaps to be addressed in clinical practice (including asking history questions, making referrals, requesting lab tests, and dispensing or prescribing medicines) for cancer-related conditions in primary care settings. |
| Ethics approval(s) |
1. Approved 28/01/2025, African Population Health Research Center (APHRC Campus, 2nd Floor, Manga Close, Off Kirawa Road, Nairobi, PO Box 10787-00100, Kenya; +254 (0)720098388; info@aphrc.org), ref: DOR/2024/063 2. Approved 17/03/2025, AMREF Ethics and Scientifc Review Committee (Amref Health Africa in Kenya, Nairobi, Nairobi, PO Box 30125-00100, Kenya; +254 (02)206994000; info.kenya@amref.org), ref: ESRC P1841/2025 3. Approved 14/05/2025, National Commission for Science, Technology and Innovation (Off Waiyaki Way, Upper Kabete, Nairobi, PO Box 30623 - 00100, Kenya; +254 (0)204007000; dg@nacosti.go.ke), ref: NACOSTI/P/25/4173261 4. Approved 17/01/2025, Oyo State Ministry of Health Research Ethics Committee (HREC) (Ministry of Health, Department of Planning, Research and Statistics Division, Ibadan, Private Mail Bag No, Nigeria; +234 (0)8038210122; info@oyostate.gov.ng), ref: NHREC/OYOSHRIEC/10/11/22 5. Approved 04/02/2025, University of Ibadan/University College Hospital Ethics Committee (UI/UCH EC) (Institute for Advanced Medical Research and Training (IAMRAT), Ibadan, 200285, Nigeria; +234 (0)8023268431; ikeajayi2003@yahoo.com), ref: NHREC/05/01/2008a 6. Approved 19/12/2024, Bayero University, Kano - Health Research Ethics Committee (BUK-HREC) (Bayero University - Health Research Ethics Committee (BUK-HREC), Kano, P.M.B. 3011, Nigeria; +234 (0)8032349387; provost.chs@buk.edu.ng), ref: NHREC/BUK-HREC/546/10/2311 7. Approved 28/12/2024, Health Research Ethics Committee of Kano State of Nigeria Ministry of Health (Kano State of Nigeria Ministry of Health, 2nds and 3rd Floor, Post Office Road, Kano, P.M.B 3066, Nigeria; +234 (0)8033238779; smoh.kano2019@gmail.com), ref: NHREC/17/03/2018 |
| Health condition(s) or problem(s) studied | Non-communicable diseases in primary care |
| Methodology | We will develop a series of standardised patient cases to describe a patient presentation and to guide responses over five knowledge domains of history taking, clinical examination, differential diagnosis, treatment/management and next steps. Following the consultation, the standardised patient will complete a form that forms the basis for assessment over the above five domains; did the clinician ask the appropriate questions, do or offer the correct examination, explain the possible causes clearly, take the correct action in terms of testing or referring and explain what would happen next and why. Standardised patients will then be recruited and trained following a process with which we are familiar. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 13/08/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 24 Years |
| Upper age limit | 58 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 71 |
| Key inclusion criteria | The individuals involved in this study are standardised patients (who aim to pass as a normal patient) and will be recruited based on the characteristics of the case they are presenting. All the standardised patients portraying a particular scenario are meticulously trained and rehearsed to ensure that the clinical presentation as well as the emotional, physical and psychosocial aspects of the patient they represent — speech, body language, dress, reactions to physical examinations — are standardised thus ensuring that each provider, when meeting an SP, will face the same clinical challenge. |
| Key exclusion criteria | Individuals who do not pass the training selection process |
| Date of first enrolment | 10/06/2025 |
| Date of final enrolment | 13/08/2025 |
Locations
Countries of recruitment
- Kenya
- Nigeria
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
13/02/2026: Study's existence confirmed by the NIHR.
