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.
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
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);
Single group
Death education intervention for family caregivers of advanced cancer patients
BehavioralThe 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.
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.
Feasibility outcome: eligibility rate
Eligibility rate will be calculated by dividing the number of participants eligible by the number of participants screened.
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.
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.
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.
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.
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.
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.
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The Hong Kong Polytechnic University
Lead sponsor
The Seventh Affiliated Hospital of Sun Yat-sen University
Collaborator
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