An Interactive Advance Care Planning Intervention to Facilitate a Good Death for Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 466
- 试验地点
- 2
- 主要终点
- Family quality of life
研究概览
简要总结
The purpose of this 5-year interventional study is to design, implement, and evaluate the effectiveness of an intervention aimed at facilitating prognosis communication and end-of-life care decision-making to increase the extent of congruence between the patient's preferred and actual EOL care received and patients' and family caregivers' QOL and psychological well-being, reduce futile aggressive healthcare resources utilization at end-of-life, and facilitate bereavement adjustment.
详细描述
A randomized controlled trial with a tailored, multifaceted intervention will be conducted on a convenience sample of 231 dyads of terminally ill cancer patients and caregivers with the same number of attention controlled group to evaluate the intervention's effectiveness.
Sample size calculation: There was no interventional study directly investigating the effectiveness in increasing the extent of congruence between patient preferred and actual end-of-life (EOL) care received by terminally ill cancer patients; therefore sample size estimation will be based on the effectiveness of holding EOL care discussions between patients and physicians on the extent to increase congruence between the patient's preferred and actual EOL care received. Patients who reported having EOL care discussions with their physicians significantly more likely to receive EOL care consistent to their preferences (OR=2.26; p<.0001) and received significantly fewer aggressive medical interventions near death, with lower rates of CPR (0.8% vs 6.7%; AOR, 0.16; 95% CI, 0.03-0.80), mechanical ventilation support (1.6% vs 11.0%; AOR, 0.26; 95% CI, 0.08-0.83), and ICU care (4.1% vs 12.4%; AOR, 0.35; 95% CI, 0.14-0.90), respectively. A sample size of 124-195 dyads per group achieves 80% power to detect a difference between the interventional and control group by a two-sided hypothesis test with a significance level of 0.05. In compensating the 18.5% of attrition rate found in our previous longitudinal study, 147-231 dyads per group are needed. The proposed sample size will be targeted on 231 dyads per group to ensure adequate power to detect the hypothesized effects of the proposed intervention.
Approximately 8-10 new dyads of terminally ill cancer patients and their family caregivers were recruited in each month. In order to recruit the targeted 462 dyads (231 dyads in each treatment group) of subjects, after development of detailed study protocol, subjects will start to enter into the study at the beginning of the 6th month of the study through the 54 th month and be followed through the 5th year of the proposed study period. We will enroll and randomly assign eligible dyads of terminally ill cancer patients and their family caregivers into intervention or attention controlled group in a 1:1 fashion without stratification.
Data collection procedures: Assessments will be performed prospectively and continue until patient death, loss to follow-up, study withdrawal, or when the patient can no longer be interviewed. An every-3-week time frame will be used in this study for repeated QOL and other outcomes assessments for both patients and their family caregivers bases on the review of literature to cover the most rapid change of patient physical conditions and demanding period of caregiving until the death of the patient. After each patient's death, a chart review and postmortem interview with patients' caregivers will be performed to confirm the type of medical care received at the EOL. Bereavement interviews will be conducted 1, 3, 6 and 13 months after the time of death in order to avoid contamination on the basis of anniversary grief reactions.1
Several strategies will be taken to ensure research fidelity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Terminally ill cancer patients are they:
- •have a disease at a terminal stage which continues to progress with distant metastases and is unresponsive to current curative cancer treatment as judged by their oncologists
- •are cognitively competent
- •can communicate with data collectors
- •have a designated family caregiver who agrees to participate in the survey.
- •Family caregivers will be recruited if they are:
- •family members of cancer patients with a terminally ill disease as defined by this proposed study
- •identified by the patients as the persons primarily conduct the patient's care needs without receiving financial reimbursement for the care they provide
- •who agree to participate and can communicate with data collectors.
排除标准
- •Patients or family caregivers who are not able to communicate coherently.
- •Only one party in the patient-family dyad agrees to participate.
研究组 & 干预措施
Attention usual care intervention
Interventions includes prognosis disclosure and discussions of EOL care as needed as in current clinical practices.
Interventions of the attention usual care arm include a consistent master prepared nurse on the study team will provide the attention portion of the care and a workbook and a video with educational materials. The initial meeting will occur before the patient discharges from hospital and the usual care nurse will give patients and family caregivers a workbook and a video with educational materials on how to manage common symptoms and a comprehensive list of resources available, including patient support organizations, support and financial assistance through the social work department.
干预措施: Attention usual care (Behavioral)
Interactive advance care planning
The intervention aims at facilitating patients, families, and primary physicians to discuss the patient's wishes for EOL care by clarifying a terminally ill cancer patient's understanding of his/her prognosis and treatment options and her/his readiness for engagement in ACP, appropriately weighting the benefits and burdens of medical treatments at EOL, and clearly defining and documenting the patient's preferences so as to be readily available later for the patient's primary physician to guide EOL care decision-making which will honor the patient's preferences for EOL care.
干预措施: Interactive advance care planning (Behavioral)
结局指标
主要结局
Family quality of life
时间窗: An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
Quality of life for family caregivers while they provide end-of-life care will be measured by the Caregiver Quality of Life Index-Cancer.
Bereavement adjustment-complicated grief
时间窗: Bereavement interviews will be conducted 1, 3, 6 and 13 months after the time of death in order to avoid contamination on the basis of anniversary grief reactions.
Complicated grief experience by family caregivers during their bereavement will be measured by the Inventory of Complicated Grief.
Quality of life for terminally ill cancer patients
时间窗: An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
McGill Quality of Life Questionnaire will be used to measure quality of life.
Congruence between preferred and actual EOL care received
时间窗: An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
EOL care includes (1) life-prolonging or comfort-oriented EOL care, (2) CPR when life is in danger, (3) life-sustaining treatments, including cardiac massage, mechanical ventilation, ICU care, tube feeding, intravenous nutrition, and hemodialysis, and (4) hospice care.
Psychological well-beings for terminally ill cancer patients
时间窗: An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
Depression and anxiety for terminally ill cancer patients. Anxiety and depressive symptoms of terminally ill cancer patients will be measured by the Hospital Anxiety and Depression Scale.
Family depressive symptoms
时间窗: An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.
Depressive symptoms will be measured by the Center for Epidemiological Studies-Depression Scale.
Bereavement adjustment-Family depressive symptoms
时间窗: Bereavement interviews will be conducted 1, 3, 6 and 13 months after the time of death in order to avoid contamination on the basis of anniversary grief reactions.
Center for Epidemiological Studies-Depression Scale will be used to measure depressive symptom for bereaved family caregivers.
次要结局
- Patient prognosis awareness(An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.)
- EOL care discussions among patients, families, and physicians(An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.)
- The extent of patient-family agreement on the preferences of EOL care(An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.)
- Family prognosis awareness(An every-3-week time frame, at a minimum, after study enrollment until patient death or subject declining to participate will be used in this study for repeated outcomes assessments. Subjects will participate for an expected average of 5 months.)
- Aggressive EOL care treatments(After each patient's death, a chart review and postmortem interview with patients' caregivers will be performed to confirm the type of medical care received at the EOL.)
研究者
Siew Tzuh Tang
Professor
Chang Gung University