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Is it possible to run a trial of early palliative care to improve person-centred outcomes of prostate and cervical cancer patients in Zimbabwe?

Integrated Palliative Oncology Care Intervention (IPOC): a hybrid parallel cluster feasibility trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98225483
Enrollment
156
Registered
2024-12-19
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate and cervical cancer Cancer

Interventions

Current interventions as of 15/10/2025: The IPOC intervention consists of three parts: 1. IPOC training: The training component of the IPOC intervention will consist of the following: 1. Training o

Sponsors

King's College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 15/10/2025: Cancer patients: 1. Adults (aged at least 18 years) 2. Diagnosis of cervical or prostate cancer (histological diagnosis is confirmed for each cancer) 3. Life expectancy of at least 6 months 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 _____ Previous 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

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 15/10/2025: Cancer patients: 1. Housebound and unable to attend tertiary care 2. Patients without a confirmed diagnosis of cancer through histology Caregivers: 1. Paid caregivers such as nurses, social workers _____ Previous 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Current secondary outcome measures as of 15/10/2025: 1. Number of prostate and cervical cancer patients, approached, meet inclusion criteria; have a family member who consents to participate in the study within 4 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 Care Association, Integrated Palliative care Outcome Scale (APCA IPOS). 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-14) 5. Patient experience (communication; emotions; short-term outcomes; barriers; and relations with staff) measured using the Patient Experience Questionnaire (PEQ) 6. Empathy that a patient feels they have received during a consultation, measured using Consultation And Rational Empathy (CARE) Family caregiver self-reported outcomes: 1. Symptoms and concerns measured using the African Palliative Care Association, Integrated Palliative care Outcome Scale (APCA IPOS). 2. Family burden measured using the Zarit Burden Inventory (ZBI-12) 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. _____ Previous secondary outcome measures: 1. Number of prostate and cervical cancer patients, approached, meet inclusion criteria; have a family mem

Countries

Zimbabwe

Contacts

Public ContactKennedy Nkhoma
kennedy.nkhoma@kcl.ac.uk+44 (0)7485116422

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026