Structured help for families in illness and focused assistance in palliative care: a randomized controlled trial (SHIFA-PC-RCT)
Caregiver support, family education, and caregiver burden among family caregivers of patients with advanced cancer receiving palliative care
Family members or caregivers will be randomized to either structured SHIFA-PC education sessions or standard verbal counselling during routine care. Participants randomized to the intervention arm will receive three structured family education sessions delivered by trained healthcare professionals. The education sessions cover an introduction to palliative care, symptom management, and emotional/spiritual support. Participants will be randomized using a computer-generated allocation sequence created before recruitment using a Python script. Participants will be randomized in a 1:1 ratio to either the structured SHIFA-PC family education intervention or standard verbal counselling. Block randomization with variable block sizes of 4 and 6 will be used. The final allocation sequence will be stored securely. The case manager will act as the randomization custodian and will reveal the allocation only after eligibility is confirmed, informed consent is completed, Study ID is assigned, and baseline assessment is completed. The enrolling team will not know the next allocation before participant enrollment and baseline assessment.
1. Adult family members/caregivers aged 18 years and above of patients receiving palliative care 2. Patient life expectancy less than 6 months 3. Family member/caregiver willing to provide informed consent
1. Families/caregivers unable to attend structured education sessions