Development and pilot of an intervention to accelerate cancer treatment in sub-Saharan Africa
| ISRCTN | ISRCTN99788471 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99788471 |
- Submission date
- 04/09/2025
- Registration date
- 12/09/2025
- Last edited
- 10/09/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- 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. Previous research has shown that a big part of the delay in cancer diagnoses in sub-Saharan Africa is due to delays within the health system, from the point when patients first present to the health care provider with symptoms to the point that they receive a diagnosis. This study is part of a wider study that seeks to reduce this delay. This sub-study aims to develop an intervention to reduce delays to cancer care, and try out the intervention in primary care facilities in Nigeria and Kenya.
Who can participate?
The study will include health professionals and patients.
Health professionals: Frontline staff working in primary care facilities who are usually the first point of contact when a patient presents to the facility with symptoms. This includes:
• Doctors
• Nurses
• Clinical officers (in Kenya)
• Community Health Extension workers (CHEWs) (in Nigeria)
Patients: Patients with who have been referred from a primary care facility with symptoms consistent with cancer
What does the study involve?
We will develop an intervention to reduce the delays to cancer care. The intervention will have three components (1) providing education to clinicians who see patients in a primary care to improve recognition and referral of individuals presenting with symptoms of cancer (2) improving clinic systems to ensure clear and consistent referral pathways, and (3) providing guidance and assistance to patients with symptoms of cancer who have been referred to the hospital.
We will then try out the intervention in 25 clinics at each site (Ibadan in Nigeria, Kano in Nigeria, and Nairobi in Kenya). We will deliver the education to up to 120 health professionals at each site, and provide guidance and assistance to up to 80 patients with referrals across the three sites.
Where is the study run from?
The study is a collaboration between the University of Birmingham in the UK, the University of Ibadan in Nigeria, the Bayero Kano University in Nigeria and the African Health and Population Research Centre in Kenya.
When is the study starting and how long is it expected to run for?
The study runs from March 2025 to December 2026.
Who is funding the study?
The National Institute for Health and Care Research (NIHR) Global Health Programme (UK)
Who is the main contact?
Jen Knight, NIHR Reducing Cancer Delays in sub-Saharan Africa Project Manager, j.knight.2@bham.ac.uk
Contact information
Scientific
Department of Applied Health Sciences
College of Medicine and Health
Murray Learning Centre
University of Birmingham
Birmingham
B31 1PE
United Kingdom
 ORCID ID |
0000-0003-0835-3495 |
|---|---|
| Phone | +44 121 414 8556 |
| p.n.k.apenteng@bham.ac.uk |
Principal Investigator
Department of Applied Health Sciences
College of Medicine and Health
Murray Learning Centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 121 414 6772 |
|---|---|
| r.j.lilford@bham.ac.uk |
Public
Department of Applied Health Sciences
College of Medicine and Health
Murray Learning Centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 121 414 5837 |
|---|---|
| j.knight.2@bham.ac.uk |
Study information
| Study design | Developing and piloting an intervention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Pilot study |
| Study setting(s) | GP practice, Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Development and pilot of an intervention to accelerate cancer treatment in sub-Saharan Africa |
| Study acronym | ACT-DAP |
| Study objectives | This study aims to develop and pilot interventions to reduce delay to cancer care within the health service in Nigeria and Kenya. Our objectives are to: 1. Develop a compound intervention consisting of educational, clinic strengthening and navigation support components. 2. Implement the intervention in 25 clinics in each site. 3. Evaluate the intervention. |
| Ethics approval(s) |
1. Approved 08/05/2025, Amref Ethics and Scientific Review Committee (Amref Health Africa in Kenya, Nairobi, P O Box 30125-00100, Kenya; +254 (02)206994000; info.kenya@amref.org), ref: ESRC P1882/2025 2. Approved 15/05/2025, Bayero University Kano Health Research Ethics Committee (Gwarzo Road, Kano, P.M.B. 3011, Nigeria; +234 8033238779; provost.chs@buk.edu.ng), ref: NHREC/BUK-HREC/613/10/2311 3. Approved 11/04/2025, College of Medicine, University of Ibadan UI/UCH Research Ethics Committee (Institute for Advanced Medical Research and Training, Ibadan, 200285, Nigeria; +234-8032349387; ikeajayi2003@yahoo.com), ref: UI/EC/25/0294 4. Approved 05/06/2025, Oyo State Ministry of Health Research Ethics Committee (Ministry of Health, Department of Planning, Research and Statistics Division, Ibadan, PMB 5027, Nigeria; +234 8038210122; info@oyostate.gov.ng), ref: NHREC/OYOSHRIEC/10/12/22 5. Approved 03/06/2025, Kano State Ministry of Health Research Ethics Committee (Kano State of Nigeria Ministry of Health, 2nd and 3rd Floor, Kano, PMB 3066, Nigeria; +234 8033238779; smoh.kano2019@gmail.com), ref: NHREC/17/03/2018 |
| Health condition(s) or problem(s) studied | Health system delays to cancer care in sub-Saharan Africa |
| Intervention | We will develop a compound intervention consisting of educational, clinic-strengthening, and navigation support components. We will implement the intervention in 25 clinics in each site (Kenya, Ibadan in Nigeria and Kano in Nigeria) and collect both qualitative and quantitative data to guide any necessary modifications to the intervention. Educational intervention: Each participating healthcare professional will receive two educational training sessions, delivered three weeks apart. The details of the education sessions, including the duration will be developed during the course of the study. All learners at all sessions will be asked to complete a brief questionnaire on their response to the learning and improvements that could be made for future delivery. Clinic strengthening and navigation assistance: 1. We will hold group interviews with facility managers and participating clinicians after intervention and clinical data collection is complete (n=1-2 groups per site, approx. 20 participants in total) to explore challenges to intervention implementation and trial procedures, how these might be resolved, and adaptation of the intervention and trial procedures. 2. Patients consenting to navigation assistance will be provided support a navigation assistant from the point of referral from primary healthcare facility to the point where it is determined that they do not have cancer or to the point where they start of treatment if they are found to have cancer. 3. Patients who have been referred to secondary care, who have consented to be contacted by the research team, will contacted 8 weeks post referral to complete a short interview and survey. |
| Intervention type | Mixed |
| Primary outcome measure | Education component: 1. Attendance at educational sessions is measured using session attendance logs at each session during the intervention period 2. Delivery process and learner engagement is measured using structured observation checklists at randomly selected educational sessions during the intervention period 3. Learner response to the education and suggestions for improvement is measured using a feedback questionnaire at the end of each educational session Clinic strengthening and navigation assistance: 4. Quality of referral record-keeping is measured using retrospective review of referral records at baseline (first few weeks of implementation) and prospective monitoring throughout the intervention period 5. Clinic staff and navigation support team engagement in implementation is measured using structured observation notes during clinic strengthening visits and navigation support meetings throughout the intervention period 6. Ability to normalise the intervention into practice is measured using the NOMAD questionnaire at first and final encounters with the implementation team 7. Patient engagement with navigator support is measured using navigator supporters’ work logs throughout the intervention period 8. Level of patient need is measured using navigator supporters’ assessment forms throughout the intervention period 9. Activities undertaken with each patient is measured using navigator supporters’ work logs (including description and duration) throughout the intervention period |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/03/2025 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 440 |
| Key inclusion criteria | Health professionals: All clinical staff working in primary care facilities who see patients for a primary care consultation. This includes all relevant cadres of clinical staff (doctors, nurses, clinical officers (Kenya), community health extension workers (Nigeria)) Patients: 1. Patients aged above 18 years who have been referred to secondary care with symptoms consistent with cancer 2. Patients referred from the participating clinics a clinic providing primary care services |
| Key exclusion criteria | Health professionals: Does not see patients in a clinical setting |
| Date of first enrolment | 01/08/2025 |
| Date of final enrolment | 30/09/2026 |
Locations
Countries of recruitment
- Kenya
- Nigeria
Study participating centres
Ibadan
200132
Nigeria
Nairobi
P.O. Box: 10787-00100
Kenya
Kano
PMB3011
Nigeria
Sponsor information
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 414 3344 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 | Planned publication in a peer-reviewed journal |
| IPD sharing plan | Not provided at time of registration |
Editorial Notes
04/09/2025: Trial's existence confirmed by Amref Ethics and Scientific Review Committee.
