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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
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.
The Seventh Affiliated Hospital of Sun Yat-Sen University
Shenzhen, Guangdong, China
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Post-intervention, up to 4 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: Baseline; Week 4