A Feasibility Study of Death Education Intervention for F... | NCT07367984

Status Module

Name	Class
The Seventh Affiliated Hospital of Sun Yat-sen University	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The intervention group	Experimental	A 4-week face-to-face death education intervention provided by a trained registered nurse	Behavioral: Death education intervention for family caregivers of advanced cancer patients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Death education intervention for family caregivers of advanced cancer patients	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	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.	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.	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

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria for patients:

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.

Exclusion Criteria for patients:

-The patient has no primary family caregiver during the study period.

Inclusion Criteria for family caregivers:

Age 18 years or older;
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.

Exclusion Criteria for family caregivers:

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;
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.