Structured family education for caregivers in palliative care

ISRCTN	ISRCTN15560493
DOI	https://doi.org/10.1186/ISRCTN15560493
Sponsor	SEHA Tawam Hospital
Funder	SEHA Tawam Hospital

Submission date: 02/05/2026
Registration date: 05/05/2026
Last edited: 05/05/2026

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Family members and caregivers play an important role in supporting patients receiving palliative care, especially in advanced cancer. However, many caregivers may feel uncertain about what palliative care means, how to recognize and manage common symptoms, and how to cope emotionally. This study aims to find out whether a structured three-session family education program can improve caregiver knowledge, confidence, satisfaction, and caregiver burden compared with standard verbal counselling.

Who can participate?
Adult family members or caregivers aged 18 years and above of patients receiving palliative care at Tawam Hospital can participate. The patient should have an estimated life expectancy of less than 6 months, and the family member or caregiver must be willing to provide informed consent. Family members or caregivers who are unable to attend the structured education sessions cannot participate.

What does the study involve?
Participants will be randomly assigned to one of two groups. One group will receive the structured SHIFA-PC family education program, which includes three sessions of approximately 30 minutes each. The sessions cover an introduction to palliative care, symptom management, and emotional and spiritual support. The other group will receive standard verbal counselling during routine care. Participants will complete questionnaires at baseline, after the education sessions or equivalent follow-up point, and at 1 month.

What are the possible benefits and risks of participating?
Participants may benefit from improved understanding of palliative care, symptom management, and caregiver support. The study may also help improve future family education in palliative care. There may be no direct personal benefit. Possible risks are minimal but may include emotional discomfort when discussing palliative care, caregiving stress, or end-of-life issues. Participants may pause or stop at any time, and concerns can be discussed with the healthcare team.

Where is the study run from?
Tawam Hospital (United Arab Emirates)

When is the study starting and how long is it expected to run for?
June 2026 to October 2026

Who is funding the study?
Tawam Hospital (United Arab Emirates)

Who is the main contact?
Dr Nandan Maruti Shanbhag, nshanbhag@seha.ae, onco@drnandan.com

Contact information

Dr Nandan Shanbhag
Principal investigator, Public, Scientific

SEHA Tawam Hospital, Al Maqam
Al Ain
12345
United Arab Emirates

Phone	+971 (0)37074757
Email	nshanbhag@seha.ae

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Supportive care
Scientific title	Structured help for families in illness and focused assistance in palliative care: a randomized controlled trial (SHIFA-PC-RCT)
Study acronym	SHIFA-PC-RCT
Study objectives	The objective of this study is to evaluate whether a structured three-session family education intervention improves palliative care knowledge among family caregivers of patients receiving palliative care compared with standard verbal counselling. Secondary objectives are to assess whether the intervention improves caregiver confidence in symptom management, caregiver satisfaction, and caregiver burden measured using the Zarit Burden Interview.
Ethics approval(s)	1. Approved 27/08/2025, Abu Dhabi Health Research and Technology Ethics Committee (ADHRTC) (Department of Health – Abu Dhabi, Abu Dhabi, 5674, United Arab Emirates; +971 (0)2 4493333; medical.research@doh.gov.ae), ref: DOH/ADHRTC/2025/1999 2. Approved 27/08/2025, Al Ain Region Human Research Ethics Committee (REC) (SEHA Tawam Hospital, Khalifa Bin Zayed Street, Al Ain, 15258, United Arab Emirates; +971 (0)37074757; clinicalresearch@seha.ae), ref: MF2058-2025-1305
Health condition(s) or problem(s) studied	Caregiver support, family education, and caregiver burden among family caregivers of patients with advanced cancer receiving palliative care
Intervention	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.
Intervention type	Behavioural
Primary outcome measure(s)	Palliative care knowledge measured using the approved SHIFA-PC symptom checklist at baseline and immediate follow-up after the third education session or equivalent control follow-up point
Key secondary outcome measure(s)	Palliative care knowledge measured using the approved SHIFA-PC symptom checklist at baseline and 1-month follow-up after the third education session or equivalent control follow-up point Caregiver confidence in symptom management measured using approved SHIFA-PC questionnaire confidence items at baseline, immediate follow-up after the third education session or equivalent control follow-up point, and 1-month follow-up Caregiver burden measured using the 22-item Zarit Burden Interview at baseline and 1-month follow-up Caregiver satisfaction measured using approved SHIFA-PC satisfaction survey items at immediate follow-up after the third education session or equivalent control follow-up point, and 1-month follow-up where applicable Session feedback and acceptability measured using approved SHIFA-PC session feedback items and open-ended responses at completion of the structured education sessions
Completion date	30/10/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	20
Total final enrolment	20
Key inclusion criteria	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
Key exclusion criteria	1. Families/caregivers unable to attend structured education sessions
Date of first enrolment	01/06/2026
Date of final enrolment	31/08/2026

Locations

Countries of recruitment

United Arab Emirates

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file			05/05/2026	No	No
Statistical Analysis Plan	version 1.0		05/05/2026	No	No

Additional files

49461_PROTOCOL.pdf: Protocol file
49461_SAP_V1.0.pdf: Statistical Analysis Plan

Editorial Notes

05/05/2026: Study's existence confirmed by the Abu Dhabi Health Research and Technology Ethics Committee (ADHRTC).