Diagnosis of cancer in Nairobi, Kenya: duration and causes of delay
| ISRCTN | ISRCTN31974245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31974245 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | NIHR158242 |
| Sponsor | University of Birmingham |
| Funder | National Institute for Health and Care Research |
- Submission date
- 24/03/2025
- Registration date
- 17/04/2025
- Last edited
- 07/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Cancer is a leading cause of death worldwide. Patients with cancer in sub-Saharan Africa have a higher death rate than patients with cancer in high-income countries. This is largely because the majority of patients in sub-Saharan Africa present with cancer late, when it has done a lot of damage to the body and the chances of a cure are low. It is therefore important that patients are diagnosed earlier so that they can receive treatment before the cancer spreads. This study aims to better understand delays in the pathway to care and the factors contributing to these delays in Kenya. The study is focused on four common cancer types: breast, colorectal, head-and-neck, and cervical cancer. These cancers are treatable if diagnosed early and often present noticeable symptoms.
Who can participate?
Patients aged 18 years and older who have been diagnosed for the first time with breast, colorectal, head-and-neck, or cervical cancer, who present at the Kenyatta National Hospital, a government-owned national referral and specialized hospital in Kenya.
What does the study involve?
The study will involve one-to-one interviews with patients diagnosed with the selected cancers. A semi-structured questionnaire will be used to explore the time to diagnosis in three stages:
The first stage is from when the patient first notices a change in their body/symptom to when they first present to a formal healthcare provider.
The second stage is from when the patient presents to a formal healthcare provider to when they receive a cancer diagnosis.
The third stage is from when the patient receives a diagnosis to when they start treatment.
The study will recruit 40 to 50 patients for each cancer type from Kenyatta National Hospital. A clinician or nurse from the hospital will assist in identifying and approaching the eligible patients. If the patient agrees to participate, their contact details will be shared with the research team, who will then arrange an interview.
All participants will be required to provide written consent before the interviews.
The researchers will examine the information from the interviews to calculate the time between each of the stages and identify the reasons for the delay at each stage.
What are the possible benefits and risks of participating?
There are no direct benefits or risks of participating in the study. However, some patients may find it distressing to discuss their cancer journey. The research team is trained to provide support and refer patients to emotional support services if needed. If a patient becomes too distressed, the interview will be stopped.
Where is the study run from?
The study is a collaboration between the African Population and Health Research Center (APHRC) in Kenya, the University of Birmingham in the UK, and the University of Ibadan in Nigeria.
When is the study starting and how long is it expected to run for?
November 2024 to July 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) Global Health Programme (UK)
Who is the main contact?
Lyagamula Kisia, lkisia@aphrc.org
Contact information
Principal investigator
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0002-0634-984X |
|---|---|
| Phone | +44 (0)121 414 6772 |
| r.j.lilford@bham.ac.uk |
Public, Scientific
APHRC Campus
Manga Cl
Nairobi
PO Box 10787-00100
Kenya
| ORCID ID |
0000-0002-2045-6158 |
|---|---|
| Phone | +254 (0)720 098388 |
| lkisia@aphrc.org |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Mixed-methods cross sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | The delays in cancer care and the associated causes of the delays in Nairobi, Kenya |
| Study objectives | The findings will provide preliminary evidence to inform policy and decision-makers in designing and implementing multilevel and holistic approaches to cancer control and improving the overall care pathway. It will also inform subsequent work packages in a programme of work in which this is the first part. |
| Ethics approval(s) |
1. Approved 05/11/2024, African Population Health Research Center (APHRC) (APHRC Campus, Manga Close, Kirawa road, Nairobi, PO Box 10787-00100, Kenya; +254 (0)722205933; info@aphrc.org), ref: DOR/2024/058 2. Submitted 15/11/2024, Kenyatta National Hospital/University of Nairobi (Ethics and Research Committee, College of Health Sciences, Nairobi, PO Box 19676-00202, Kenya; +254 (0)721257746; uoknh_erc@uonbi.ac.ke), ref: N/A 3. Not yet submitted, National Commission for Science, Technology and Innovation (Waiyaki Way, Upper Kabete, Nairobi, PO Box 30623, 00100, Kenya; +254 (0)204007000; info@nacosti.go.ke), ref: N/A |
| Health condition(s) or problem(s) studied | Breast, colorectal, head-and-neck, or cervical cancer |
| Intervention | Semi-structured interviews with patients with a recent diagnosis of cancer to elicit patients' accounts of their cancer care pathway The study will involve one-to-one interviews with patients diagnosed with the selected cancers. A semi-structured questionnaire will be used to explore the time to diagnosis in three stages: The first stage is from when the patient first notices a change in their body/symptom to when they first present to a formal healthcare provider. The second stage is from when the patient presents to a formal healthcare provider to when they receive a cancer diagnosis. The third stage is from when the patient receives a diagnosis to when they start treatment. The study will recruit 40 to 50 patients for each cancer type from Kenyatta National Hospital. A clinician or nurse from the hospital will assist in identifying and approaching the eligible patients. If the patient agrees to participate, their contact details will be shared with the research team, who will then arrange an interview. All participants will be required to provide written consent before the interviews. The researchers will examine the information from the interviews to calculate the time between each of the stages and identify the reasons for the delay at each stage. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Duration of delays will be measured using a semi-structured interview instrument at three timepoints that is point 1 (recognition of symptoms to presentation to a formal healthcare provider), point 2 (presentation to a formal healthcare provider to diagnosis), point 3 (diagnosis to resolution). |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 160 |
| Key inclusion criteria | 1. Patients with a first histologically confirmed diagnosis of breast, colorectal, head and neck, or cervical cancer 2. Patients aged 18 years and above 3. Patients referred from the Nairobi Metropolitan Area (NMA) 4. Patients capable of providing informed consent |
| Key exclusion criteria | 1. Patients with a diagnosis of a cancer secondary to a primary cancer 2. Any patients who are acutely ill or receiving end-of-life care 3. Patients with a recurrent cancer |
| Date of first enrolment | 15/04/2025 |
| Date of final enrolment | 15/06/2025 |
Locations
Countries of recruitment
- Kenya
Study participating centre
Nairobi
PO Box 20723-00202
Kenya
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/03/2025: Study's existence confirmed by the NIHR.
