Is it possible to run a trial of early palliative care to improve person-centred outcomes of prostate and cervical cancer patients in Zimbabwe?
ISRCTN | ISRCTN98225483 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN98225483 |
Secondary identifying numbers | GHRUG NIHR134440 |
- Submission date
- 02/11/2024
- Registration date
- 19/12/2024
- Last edited
- 27/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
People living with prostate and cervical cancer experience pain, shortness of breath and other physical problems and concerns and may require support with physical, psychosocial or spiritual care. This study is designed to understand the care of patients and families living with cervical or prostate cancer to see if additional care (focussing on physical e.g. pain, psychological e.g. worry, social e.g. costs and spiritual e.g. your religious beliefs) will improve patient and caregiver experience of living with cervical or prostate cancer.
Who can participate?
1. Adult (at least 18 years old) patients with a confirmed diagnosis of cervical or prostate cancer attending care at Parirenyatwa or Mpilo hospitals in Zimbabwe
2. Adult family caregivers (at least 18 years old) of patients living with cervical or prostate cancer
3. Cervical or prostate cancer patients who are receiving any form of cancer treatment either chemotherapy, radiotherapy, surgery, immunotherapy
4. Patients who are able to communicate in English, Shona or Ndebele and able to give informed consent
What does the study involve?
The following will happen if patients and caregivers decide to part:
1. They will be asked to meet a study researcher to describe their health-related needs and concerns, and the services that they use
2. The researcher will extract the patient's health records held at the health facility where the patient receives medical care. The records to be extracted include the date of diagnosis, other illnesses, clinical stage of the illness, current treatment, hospitalisation history, etc.
3. The researcher will read aloud questions to study participants, and participants will provide responses/answers, the researcher will then record the responses/answers. This interview will be conducted at the health care facility or patient's home initially as the enrol in the study and every month for 12 months. Follow-up interviews may be conducted by phone.
4. After all patients and caregivers enrol in the study, the two sites (Parirenyatwa and Mpilo Hospital) will be randomly allocated to intervention and control. Either Parirenyatwa or Mpilo Hospital will become the intervention or control site.
5. Healthcare professionals at the intervention facility will be trained to provide person-centred care (cancer care alongside supportive care). Healthcare professionals at the control facility will not receive any training. They will provide care as usual (cancer care only).
6. Patients and caregivers at the intervention site receive care from healthcare professionals who have received training.
7. Patients and caregivers at the control site will receive care from health professionals with no exposure to training.
What are the possible benefits and risks of participating?
There are no known direct benefits to the participants at the moment, though it may benefit future patients.
The risks expected with participation in this study are related to the questions that the researchers are going to ask participants about cancer illness. Some of the questions might cause distress. If patients or caregivers become upset or distressed, the researchers will offer a chance for them to take some time out of the interview and then either carry on or stop the interview completely. In addition, the services of a counsellor will be made available to all participants at no cost should they need these services.
Where is the study run from?
Parirenyatwa Hospital in Harare and Mpilo Hospital in Bulawayo (Zimbabwe)
When is the study starting and how long is it expected to run for?
We are starting recruitment on 2nd January 2025, and we expect to finalise recruitment on 31st January 2026.
Who is funding the study?
The National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
UK: Prof. Richard Harding, richard.harding@kcl.ac.uk
Zimbabwe: Dr Dickson Chifamba
Contact information
Scientific, Principal Investigator
Cicely Saunders Institute of Palliative Care Policy and Rehabilitation
Denmark Hill Campus
Bessemer Road
London
SE5 9PJ
United Kingdom
0000-0001-9653-8689 | |
Phone | +44 (0)207 848 5518 |
richard.harding@kcl.ac.uk |
Public, Scientific
Cicely Saunders Institute of Palliative Care Policy and Rehabilitation
Denmark Hill Campus
Bessemer Road
King's College London
London
SE5 9PJ
United Kingdom
0000-0002-2991-8160 | |
Phone | +44 (0)7485116422 |
kennedy.nkhoma@kcl.ac.uk |
Study information
Study design | Hybrid parallel cluster feasibility randomized controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Cluster randomised trial |
Study setting(s) | Built environment/local authority |
Study type | Quality of life |
Scientific title | Integrated Palliative Oncology Care Intervention (IPOC): a hybrid parallel cluster feasibility trial |
Study acronym | IPOC |
Study objectives | Aim: To determine the feasibility of evaluating an integrated cancer/oncology palliative care using a randomized controlled trial (RCT) design. Objectives: 1. Determine trial recruitment rates to an RCT for prostate and cervical cancer patients and family members 2. Measure completion of potential patient and family outcome and staff cost data, intervention implementation 3. Determine staff, patient and family views of the intervention and its processes 4. Confirm primary outcome measure and potential effect size, identify contamination, and develop full trial protocol if full trial is warranted 5. Develop methodological guidance for palliative care trials in Low- and Middle-Income Countries (LMICs) and intervention manual adaptation to partner countries Research questions: 1. What is a feasible and acceptable model of integrated palliative care to improve self-reported outcomes for cancer patients and their families, and can it be implemented? 2. Is an RCT feasible in terms of delivery of the intervention and recruitment/retention to the trial? 3. What are stakeholder views of the intervention and evaluation processes? 4. Is a full trial warranted and what is the optimum trial design? |
Ethics approval(s) |
1. Approved 17/10/2024, King's College London Research Ethics Committee (Research Ethics Office, 5-11 Lavington St, London, SE1 0NZ, United Kingdom; +44 (0)207 848 5554; rec@kcl.ac.uk), ref: HR/DP-23/24-45379 2. Submitted 30/10/2024, Medical Research Council of Zimbabwe (20 Cambridge Road, Avondale, Harare, -, Zimbabwe; +263 (0)8644073772; mrcz@mrcz.org.zw), ref: MRCZ/A/3029 |
Health condition(s) or problem(s) studied | Prostate and cervical cancer |
Intervention | The IPOC intervention consists of three parts: 1. IPOC training: The training component of the IPOC intervention will consist of the following: 1. Training of healthcare professionals/oncologists and palliative care on: 2. The principles of Palliative care 3. The principles of Oncology care 4. Palliative care and oncology integration 5. Person-centered care 6. Pain and symptom assessment and management 7. Psychosocial care and decision-making support 8. Spiritual care and support 9. Person-centred communication, including handling difficult communication and prognosis, breaking bad news 10. Documentation 11. Goal setting 12. Developing action plans 13. End-of-life care discussions and bereavement support 14. Joint clinical appointments/ward rounds 15. Referral mechanism and signposting 16. For patients and caregivers 17. Goal setting and developing action plans 18. Information provision 19. Patient education 2. Process Logic Model The current processes of care delivery within the healthcare facilities will be taken into consideration, to ensure the IPOC intervention fits with the current structure and can be adapted easily to the current structure. The researchers conducted a theory of change workshop and developed a process logic model to guide all stakeholders involved in the delivery of the intervention. The logic model clarifies the care pathway for prostate and cervical cancer patients and their families as they access the IPOC intervention, and the other preliminary activities needed for the scaling of the intervention into healthcare facilities. 3. Mentorship and support The other component of the IPOC intervention is mentorship and support. This will consist of weekly sessions between trained healthcare professionals and mentees from Island Hospices and the University of Zimbabwe. The mentor and mentee will develop mentorship goals, plans and strategies to implement the goals, including identification of resources. The researchers will recruit 39 cervical cancer and 39 prostate cancer patients at Parirenyatwa Hospital in Harare-Zimbabwe. They will also recruit 39 cervical cancer and 39 prostate cancer patients at Mpilo in Bulawayo-Zimbabwe. Patients will be recruited with their family caregivers. They aim to recruit these patients within 2 months. The patients will be invited to complete self-reported measures which capture their demographic and clinical characteristics, symptoms and concerns, and their experiences receiving care at the two facilities. Using a computer, the researchers will allocate one of the two sites to receive the intervention, which is palliative care and cancer care provided together. The site that has been chosen to receive the intervention will deliver new methods of care to cancer patients and their families. All healthcare professionals working at the site will undergo weekly training for 1 month consisting of: 1. Provision of cancer care and palliative care 2. Person-centred care 3. Person-centred communication 4. Pain and symptom management 5. End of life care After the training healthcare professionals will then use the new knowledge and skills to provide palliative and cancer care to patients and their families. Trained healthcare professionals will also be mentored, supported and supervised by experienced palliative care and cancer professionals. Mentorship sessions will be held every two weeks for 10 months. All patients will continue to receive care from healthcare professionals at both sites. All patients and their families from both study sites will complete self-reported outcomes monthly for 12 months. Hospitals sites will be randomised. One site will be the intervention site. At the intervention site healthcare professionals will receive the intervention. Patients will therefore receive care from healthcare professionals who have been trained in palliative and oncology care. At the control site, patients will receive care from healthcare professionals with no exposure to the intervention. |
Intervention type | Behavioural |
Primary outcome measure | 1. Trial recruitment at each site: 1.1. Number of eligible prostate and cervical cancer participants who consent to participate in the study within 6 weeks 1.2. Number of eligible family caregivers of prostate and cervical cancer participants who consent to participate in the study within 6 weeks 2. Trial retention at each site: 2.1. Number of prostate and cervical cancer participants who consented to participate and remain in the study each month for 12 months 2.2. Number of family caregivers of prostate and cervical cancer participants who consented to participate and remain in the study each month for 12 months |
Secondary outcome measures | 1. Number of prostate and cervical cancer patients, approached, meet inclusion criteria; have a family member who consents to participate in the study within 6 weeks at each site. 2. Number of cervical and prostate cancer patients able to complete each timepoint; die within follow-up period; and place of death 3. Time to complete person-reported outcome measures (researcher read aloud and record response) 4. Intervention exposure, intervention fidelity: number of contacts with the intervention staff 5. Contamination/control group contacts with the intervention (% of intended contacts and activity, control exposure) Patient self-reported outcomes: 1. Symptoms and concerns measured using the African Palliative Outcome Scale 2. Psychological morbidity measured using General Health Questionnaire (GHQ-12) 3. Physical function measured using the Palliative Performance Scale 4. Quality of life measured using the functional assessment of chronic illness therapy-palliative care (FACIT-Pal) 5. Patient experience (communication; emotions; short-term outcomes; barriers; and relations with staff) measured using the Patient Experience Questionnaire 6. Empathy that a patient feels they have received during a consultation, measured using Consultation And Rational Empathy 7. Informal and formal service use, chemotherapy and surgery, admissions and length of stay, treatment access, measured using Patient and Carer Cancer Cost (PaCCCt) Family caregiver self-reported outcomes: 1. Symptoms and concerns measured using the African Palliative Outcome Scale 2. Family burden measured using the Zarit Burden Inventory All patient and caregiver self-reported outcomes will be administered at baseline and monthly for 12 months. For all outcomes, the researchers will collect data at baseline then monthly. |
Overall study start date | 01/08/2022 |
Completion date | 31/01/2026 |
Eligibility
Participant type(s) | Patient, Carer |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 156 |
Key inclusion criteria | Cancer patients: 1. Adults (aged at least 18 years) attending tertiary care at Parirenyatwa or Mpilo hospitals 2. Diagnosis of cervical or prostate cancer (histological diagnosis is confirmed for each cancer) 3. Clinical criteria: Any clinical stage of cancer. Receiving cancer treatment either chemotherapy, radiotherapy, surgery, immunotherapy or any cancer treatment 4. Able to communicate in English, Shona or Ndebele 5. Able to give informed consent Caregivers: 1. Primary caregiver to be identified by the patient, in line with the definition of caregiver “unpaid, informal providers of one or more physical, social, practical and emotional tasks. In terms of their relationship to the patient, they may be a friend, partner, ex-partner, sibling, parent, child or other blood or non-blood relative" 2. Adult at least 18 years of age 3. Able to communicate in English, Shona or Ndebele 4. Able to give informed consent |
Key exclusion criteria | Cancer patients: 1. Housebound and unable to attend tertiary care 2. Unable to give informed consent due to loss of capacity 3. Those who cannot communicate in English, Shona, Ndebele 4. Any other type of cancer other than cancer of the cervix or prostate 5. Without a confirmed diagnosis of cancer through histology Caregivers: 1. Paid caregivers such as nurses, social workers 2. Those below 18 years of age 3. Those not involved in day-to-day care for the cancer patient 4. Those involved in day-to-day care for other cancer type |
Date of first enrolment | 02/01/2025 |
Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Zimbabwe
Study participating centres
Harare
PO Box CY 198
Zimbabwe
Bulawayo
Bulawayo
PO Box 2096
Zimbabwe
Sponsor information
University/education
Vice President (Research and Innovation)
London
WC2R 2LS
England
United Kingdom
Phone | +44 (0)2078487306 |
---|---|
vpri@kcl.ac.uk | |
Website | https://www.kcl.ac.uk/ |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
Intention to publish date | 30/12/2026 |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not expected to be made available |
Publication and dissemination plan | The researchers aim to publish with BMC Global Health or palliative medicine. They will work at the country level (with governments through their existing networks and healthcare professionals); at the regional/global level (with a series of policy workshops, by their partners the African Palliative Care Association, and with their WHO Collaborating Centre) and for scientists (through African and global conferences, scientific papers and a series of international seminars to improve science in this area). |
IPD sharing plan | The researchers do not have ethics approval for data to be made available. They will store their data securely on King's SharePoint and King's OneDrive, their institutional platforms. |
Editorial Notes
27/11/2024: Study's existence confirmed by the NIHR.