Death Education Intervention for Family Caregivers of Advanced Cancer Patients: a Mixed-methods Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility outcome: time to complete the recruitment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
The intervention group
A 4-week face-to-face death education intervention provided by a trained registered nurse
干预措施: Death education intervention for family caregivers of advanced cancer patients (Behavioral)
结局指标
主要结局
Feasibility outcome: time to complete the recruitment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Death-related communication with patients(Baseline; Week 4)
- Anxiety(Baseline; Week 4)
- Depression(Baseline; Week 4)
- Spiritual well-being(Baseline; Week 4)
- Attitudes toward death(Baseline; Week 4)
- Health-related quality of life(Baseline; Week 4)
研究者
Dr CHENG Huilin
Assistant Professor
The Hong Kong Polytechnic University