A Feasibility Study of Death Education Intervention for Family Caregivers of Advanced Cancer Patients

Официальное название

Death Education Intervention for Family Caregivers of Advanced Cancer Patients: a Mixed-methods Feasibility Study

Обзор

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.

Вмешательства

• Поведенческое Death education intervention for family caregivers of advanced cancer patients
  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 interven

Первичные конечные точки

• Feasibility outcome: time to complete the recruitment [Срок оценки: Through recruitment completion, up to 4 months]
• Feasibility outcome: eligibility rate [Срок оценки: Through recruitment completion, up to 4 months]
• Feasibility outcome: recruitment rate [Срок оценки: Through recruitment completion, up to 4 months]
• Feasibility outcome: retention rate [Срок оценки: Through recruitment completion, up to 4 months]
• Feasibility outcome: attendance rate [Срок оценки: Through recruitment completion, up to 4 months]
• Acceptability outcome: participants' satisfaction and perspectives of the intervention [Срок оценки: Post-intervention, up to 4 months]
• Qualitative evaluation of acceptability [Срок оценки: Post-intervention, up to 4 months]

Вторичные конечные точки (6)

• Death-related communication with patients [Срок оценки: Baseline; Week 4]
• Anxiety [Срок оценки: Baseline; Week 4]
• Depression [Срок оценки: Baseline; Week 4]
• Spiritual well-being [Срок оценки: Baseline; Week 4]
• Attitudes toward death [Срок оценки: Baseline; Week 4]
• Health-related quality of life [Срок оценки: Baseline; Week 4]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• The Seventh Affiliated Hospital of Sun Yat-Sen University — Шэньчжэнь

Идентификаторы

NCT: NCT07367984 · 06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗