Palliative CareNCT07367984
A Feasibility Study of Death Education Intervention for Family Caregivers of Advanced Cancer Patients
A study testing Death education intervention for family caregivers of advanced cancer patients in people with Palliative Care and Advanced Cancer, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
Advanced cancer is the leading cause of death in the world and China. Family caregivers, as the closest individuals to advanced cancer patients, suffer from a range of psychological and spiritual issues due to patients' impending death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Advanced Cancer, Family Caregivers
- What is being tested?
- Death education intervention for family caregivers of advanced cancer patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- The patient with pathologically confirmed stage III or IV cancer;
- The patient has initiated any systemic anti-cancer therapy (e.g.,chemotherapy, immunotherapy, targeted therapy, endocrine therapy) and has completed the first treatment administration/cycle and commenced the next planned administration/cycle;
- The patient is assessed by the doctor as having an estimated life expectancy of ≥3 months; and
- The patient is aware of their advanced cancer diagnosis.
- Age 18 years or older;
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- The caregiver is identified by the patient as the primary family caregiver (e.g., spouse, adult child, parent, or other relative);
- The caregiver has been regularly involved in caregiving for the patient in the past month, and is expected to continue providing support over the next two months (e.g., daily care, accompaniment, involvement in medical communication/decision-making, and financial support);
- Since taking on the primary caregiving role, the caregiver reports the frequency of talking about death/dying with the patient as "Never" or "Rarely" (from: Never / Rarely / Sometimes / Often / Very often);
- The caregiver perceives a need for guidance and support in communicating with the patient about death-related matters; and
- The caregiver has basic Chinese literacy (reading and writing) to understand the intervention content and complete written tasks.
Who cannot join
- -The patient has no primary family caregiver during the study period.
- Paid or professional caregivers who receive financial compensation for providing caregiving services;
- The caregiver provides financial support only, without regular contact with the patient;
- The caregiver has significant cognitive impairment that would affect understanding the intervention and completing the study;
- The caregiver has severe psychiatric symptoms that would affect understanding the intervention and completing the study;
- The caregiver has significant communication difficulties that would affect understanding the intervention and completing the study;
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- The caregiver is unable to complete the 4-week intervention due to physical limitations (e.g., mobility restrictions preventing attendance at intervention sessions);
- The caregiver has practical constraints that would prevent completion of the 4-week intervention or follow-up assessments (e.g., expected prolonged travel during the intervention period or inability to complete assessments as scheduled); and
- The caregiver is currently receiving other structured psychological intervention or psychotherapy that is likely to affect study outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Seventh Affiliated Hospital of Sun Yat-Sen University
Shenzhen, Guangdong, 518001
Xuan Liu, (86)13533384708
Tong Wang, Msc
About this study
Official title: Death Education Intervention for Family Caregivers of Advanced Cancer Patients: a Mixed-methods Feasibility Study
Advanced cancer is the leading cause of death in the world and China. Family caregivers, as the closest individuals to advanced cancer patients, suffer from a range of psychological and spiritual issues due to patients' impending death. Various types of death education interventions have been developed to assist individuals in understanding the meaning of life and death and adapting to dying to address psychological and spiritual issues. However, these interventions have predominantly focused on advanced cancer patients only, with a significant gap in support for family caregivers.
A mixed methods feasibility study will be conducted. A convenience sample of at least 30 family caregivers will be recruited. Participants will receive four 60-minute sessions, flexibly scheduled within a four-week period according to each participant's conditions. The researcher will be trained to deliver the intervention through individual face-to-face sessions in the oncology ward meeting room of the same hospital in phase I. The primary outcome will be feasibility (time to complete the recruitment, eligibility rate, recruitment rate, retention rate, attendance rate, acceptability rate). Secondary outcomes will be measured for preliminary intervention effectiveness on family caregivers' communication with patients on death, anxiety, depression, spiritual well-being, attitudes towards death, and quality of life after collecting the demographic information and written consent forms, and post-intervention. A descriptive qualitative evaluation will be conducted with 12 family caregivers to explore their experience of participating in the intervention by another researcher. The qualitative data in phase II will be audio-taped and transcribed verbatim and analysed using NVivo 14 through thematic analysis. The quantitative data will be entered in SPSS version 29.0. Descriptive statistics will be used to summarise the profiles of participants and outcomes.
- Conditions
- Palliative Care, Advanced Cancer, Family Caregivers
- Being tested
- Death education intervention for family caregivers of advanced cancer patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Death education intervention for family caregivers of advanced cancer patientsBehavioural
The intervention consists of four 60-minute face-to-face sessions, scheduled flexibly within a four-week period based on each participant's condition and availability. The intervention will be delivered face-to-face, individually in the oncology ward meeting room. The intervention sessions will cover topics such as reviewing relationships with the patient, designing legacy products, recognising death-related emotions, and saying goodbye to the patient. The intervention materials include intervention manuals, play cards, and videos, which will be provided to support session activities.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | A 4-week face-to-face death education intervention provided by a trained registered nurse Receives: Behavioral: Death education intervention for family caregivers of advanced cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome: time to complete the recruitment
Time to complete the recruitment will be assessed by the time duration from the beginning to the completion of the recruitment.
Measured: Through recruitment completion, up to 4 months
Feasibility outcome: eligibility rate
Eligibility rate will be calculated by dividing the number of participants eligible by the number of participants screened.
Measured: Through recruitment completion, up to 4 months
Feasibility outcome: recruitment rate
Recruitment rate will be calculated by dividing the number of eligible participants who have consented and been enrolled by the total number of eligible participants.
Measured: Through recruitment completion, up to 4 months
Feasibility outcome: retention rate
Retention rate will be calculated by dividing the number of participants completed the study with valid outcome data by the number of participants enrolled at the baseline.
Measured: Through recruitment completion, up to 4 months
Feasibility outcome: attendance rate
Attendance rate will be calculated by dividing the number of participants completed 4 interventional sessions by the number of participants enrolled at baseline.
Measured: Through recruitment completion, up to 4 months
Acceptability outcome: participants' satisfaction and perspectives of the intervention
Participants' perspectives and satisfaction will be assessed using a self-developed questionnaire, designed for this study based on the Theoretical Framework of Acceptability
Measured: Post-intervention, up to 4 months
Qualitative evaluation of acceptability
A qualitative evaluation will explore the acceptability of the death education intervention among family caregivers. Semi-structured individual interviews will be conducted after participants complete the intervention, using an interview guide focused on their overall experience and perceived usefulness of the sessions. All interviews will be audio-recorded and transcribed verbatim.
Measured: Post-intervention, up to 4 months
Secondary outcomes (6)
Death-related communication with patients
Family caregivers' death-related communication with patients will be assessed using the Caregivers' Communication with Patients about Illness and Death Scale (CCID, Chinese version). Each item is rated on a five-point Likert scale (1 = not at all to 5 = to a large extent), yielding a total score range of 5-25. Higher scores indicate greater avoidance of illness- and death-related communication.
Measured: Baseline; Week 4
Anxiety
Family caregivers' anxiety will be measured using the Generalized Anxiety Disorder-7 (GAD-7, Chinese version).The GAD-7 consists of 7 items, each rated on a 4-point Likert scale (0 = not at all to 3 = nearly every day), with a total score range of 0-21. Higher scores indicate greater anxiety severity. The Chinese version retains the same items and single-factor structure as the original.
Measured: Baseline; Week 4
Depression
Family caregivers' depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9, Chinese version). The PHQ-9 includes 9 items, each rated from 0 (not at all) to 3 (nearly every day), giving a total score range of 0-27. Higher scores represent more severe depressive symptoms. The Chinese version maintains the original item structure.
Measured: Baseline; Week 4
Spiritual well-being
Family caregivers' spiritual well-being will be measured by the Spiritual Index of Well-Being (SIWB, Chinese version). The SIWB comprises 12 items, rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), with a total score range of 12-60. The scale includes two subscales (self-efficacy, and life scheme). Both total and subscale scores will be calculated, with higher total and subscale scores indicating greater spiritual well-being in the corresponding domain.
Measured: Baseline; Week 4
Attitudes toward death
Family caregivers' attitudes toward death will be assessed using the Death Attitude Profile-Revised (DAP-R, Chinese version). The DAP-R consists of 32 items across five subscales (fear of death, death avoidance, neutral acceptance, approach acceptance, and escape acceptance), each rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Interpretation of the DAP-R focuses on the pattern of subscale scores to capture individuals' multifaceted views of death. Higher scores on acceptance-related subscales (neutral acceptance and approach acceptance) generally reflect greater acceptance of death, whereas higher scores on fear- or avoidance-related subscales (fear of death, death avoidance, and escape acceptance) reflect stronger fear-based, avoidant, or escape-oriented attitudes toward death.
Measured: Baseline; Week 4
Health-related quality of life
Family caregivers' quality of life will be measured using the Quality of Life in Life-Threatening Illness - Family Carer Version (QOLLTI-F, Chinese version).
The QOLLTI-F contains 16 items covering 7 domains (environment, patient condition, carer's own state, relationships, outlook, quality of care, and financial worries). Each item is rated on an 11-point numeric scale (0 = worst possible to 10 = best possible), yielding a total score range of 0-160. Higher total scores reflect better quality of life.
Measured: Baseline; Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The Seventh Affiliated Hospital of Sun Yat-sen University
- Responsible party
- Principal investigator, Dr CHENG Huilin, The Hong Kong Polytechnic University
- Investigators
- Huilin Cheng, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367984
- Sponsor's protocol ID
- 06
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Death Education Intervention for Family Caregivers of Advanced Cancer Patients: a Mixed-methods Feasibility Study
- ClinicalTrials.gov ID
- NCT07367984
- Acronym / sponsor ID
- 06
- Conditions
- Palliative Care, Advanced Cancer, Family Caregivers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The Seventh Affiliated Hospital of Sun Yat-sen University
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Advanced cancer is the leading cause of death in the world and China. Family caregivers, as the closest individuals to advanced cancer patients, suffer from a range of psychological and spiritual issues due to patients' impending death. Various types of death education interventions have been developed to assist individuals in understanding the meaning of life and death and adapting to dying to address psychological and spiritual issues. However, these interventions have predominantly focused on advanced cancer patients only, with a significant gap in support for family caregivers.
A mixed methods feasibility study will be conducted. A convenience sample of at least 30 family caregivers will be recruited. Participants will receive four 60-minute sessions, flexibly scheduled within a four-week period according to each participant's conditions. The researcher will be trained to deliver the intervention through individual face-to-face sessions in the oncology ward meeting room of the same hospital in phase I. The primary outcome will be feasibility (time to complete the recruitment, eligibility rate, recruitment rate, retention rate, attendance rate, acceptability rate). Secondary outcomes will be measured for preliminary intervention effectiveness on family caregivers' communication with patients on death, anxiety, depression, spiritual well-being, attitudes towards death, and quality of life after collecting the demographic information and written consent forms, and post-intervention. A descriptive qualitative evaluation will be conducted with 12 family caregivers to explore their experience of participating in the intervention by another researcher. The qualitative data in phase II will be audio-taped and transcribed verbatim and analysed using NVivo 14 through thematic analysis. The quantitative data will be entered in SPSS version 29.0. Descriptive statistics will be used to summarise the profiles of participants and outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: Death education intervention for family caregivers of advanced cancer patientsA 4-week face-to-face death education intervention provided by a trained registered nurse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years or older;
- The patient with pathologically confirmed stage III or IV cancer;
- The patient has initiated any systemic anti-cancer therapy (e.g.,chemotherapy, immunotherapy, targeted therapy, endocrine therapy) and has completed the first treatment administration/cycle and commenced the next planned administration/cycle;
- The patient is assessed by the doctor as having an estimated life expectancy of ≥3 months; and
- The patient is aware of their advanced cancer diagnosis.
Key exclusion criteria (9 listed)
- -The patient has no primary family caregiver during the study period.
- Paid or professional caregivers who receive financial compensation for providing caregiving services;
- The caregiver provides financial support only, without regular contact with the patient;
- The caregiver has significant cognitive impairment that would affect understanding the intervention and completing the study;
- The caregiver has severe psychiatric symptoms that would affect understanding the intervention and completing the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Death education intervention for family caregivers of advanced cancer patientsThe intervention consists of four 60-minute face-to-face sessions, scheduled flexibly within a four-week period based on each participant's condition and availability. The intervention will be delivered face-to-face, individually in the oncology ward meeting room. The intervention sessions will cover topics such as reviewing relationships with the patient, designing legacy products, recognising death-related emotions, and saying goodbye to the patient. The intervention materials include intervention manuals, play cards, and videos, which will be provided to support session activities. | Behavioural | The intervention group |
Primary outcome
Feasibility outcome: time to complete the recruitment
Time frame: Through recruitment completion, up to 4 months
Time to complete the recruitment will be assessed by the time duration from the beginning to the completion of the recruitment.
Feasibility outcome: eligibility rate
Time frame: Through recruitment completion, up to 4 months
Eligibility rate will be calculated by dividing the number of participants eligible by the number of participants screened.
Feasibility outcome: recruitment rate
Time frame: Through recruitment completion, up to 4 months
Recruitment rate will be calculated by dividing the number of eligible participants who have consented and been enrolled by the total number of eligible participants.
Feasibility outcome: retention rate
Time frame: Through recruitment completion, up to 4 months
Retention rate will be calculated by dividing the number of participants completed the study with valid outcome data by the number of participants enrolled at the baseline.
Feasibility outcome: attendance rate
Time frame: Through recruitment completion, up to 4 months
Attendance rate will be calculated by dividing the number of participants completed 4 interventional sessions by the number of participants enrolled at baseline.
Acceptability outcome: participants' satisfaction and perspectives of the intervention
Time frame: Post-intervention, up to 4 months
Participants' perspectives and satisfaction will be assessed using a self-developed questionnaire, designed for this study based on the Theoretical Framework of Acceptability
Qualitative evaluation of acceptability
Time frame: Post-intervention, up to 4 months
A qualitative evaluation will explore the acceptability of the death education intervention among family caregivers. Semi-structured individual interviews will be conducted after participants complete the intervention, using an interview guide focused on their overall experience and perceived usefulness of the sessions. All interviews will be audio-recorded and transcribed verbatim.
6 secondary outcomes
Death-related communication with patients
Time frame: Baseline; Week 4
Anxiety
Time frame: Baseline; Week 4
Depression
Time frame: Baseline; Week 4
Spiritual well-being
Time frame: Baseline; Week 4
Attitudes toward death
Time frame: Baseline; Week 4
Health-related quality of life
Time frame: Baseline; Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huilin Cheng, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Death education intervention for family caregivers of advanced cancer patients in people with Palliative Care and Advanced Cancer, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tong Wang ((86) 13169942779, tongtong.wang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome: time to complete the recruitment (time frame: Through recruitment completion, up to 4 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.