Cross-sectional, Observational Study of Advanced Cancer Patients' and Their Primary Caregivers' Willingness to Communicate About Advance Care Planning (ACP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Rate of willingness of patients and their primary caregiver to communicate with each other and with the physician(s) about the patient's ACP.
研究概览
简要总结
Advanced care planning (ACP) is a major component of end-of-life care. Advanced care planning aims to (1) establish treatment and care options in the event that continuing cancer treatment is more risky than beneficial (e.g., participating in a clinical trial testing a new treatment; continuing supportive care only) and (2) establish possible treatment limitations in the event that a medical complication threatens the patient's survival without the patient's expressed wishes (e.g., transfer to an intensive care unit; resuscitation). However, cancer patients still rarely engage with their physician(s) and family in a discussion about ACP. The primary objective of the project is to conduct a cross-sectional, observational study of the willingness of advanced cancer patients and their primary caregivers to communicate about ACP with each other and with the physician(s); and their agreement/disagreement with these respective willingness. The secondary objective of the project is to assess the medical, psychological and relational factors associated with these willingness. This study will involve 300 consecutive patient- primary caregiver-physician(s) triads. For each patient and their primary caregiver, an in-depth assessment of their willingness to communicate about ACP with each other and with the physician(s) will be conducted using specific scales. The medical, psychological and relational characteristics of the included patients and their primary caregiver will also be assessed using validated questionnaires. Results of this study will enable to propose innovative interventions likely to optimize the establishment of an ACP for numerous advanced cancer patients.
详细描述
Advanced care planning (ACP) is a major component of end-of-life care. Advanced care planning aims to (1) establish treatment and care options in the event that continuing cancer treatment is more risky than beneficial (e.g., participating in a clinical trial testing a new treatment; continuing supportive care only) and (2) establish possible treatment limitations in the event that a medical complication threatens the patient's survival without the patient's expressed wishes (e.g., transfer to an intensive care unit; resuscitation). ACP aims to ensure that the patient receives care consistent with their personal values, life goals, and preferences. Nowadays, ACP is conceived as an iterative process of communication between patients, their families, and caregivers. However, cancer patients still rarely engage with their physician(s) and family in a discussion about ACP.
There is a gap between the recommendations that communication take place between patients, their families and physician(s) regarding end-of-life care planning, and the application of this recommendation in clinical practice. This gap threatens the quality of life care as well as the adjustment of their caregivers to this phase of the disease and the grief that follows. A thorough and rigorous study of the reasons for this discrepancy has become an essential issue for the oncology of tomorrow.
No studies have quantified the respective willingness of cancer patients and their primary caregivers to communicate about ACP with each other and with their physician(s). No studies have quantified the agreement/disagreement of these patients and their primary caregivers on this issue. No study has assessed the medical, psychological, and relational factors associated with these respective willingness and agreements/disagreements.
This is a cross-sectional observational study. On a weekly basis, the list of eligible patients having a consultation at the Institut Jules Bordet in the medical oncology, hematology, surgery or radiotherapy departments will be provided by the Institute's IT department. An audit of the patients' medical records will be performed by the evaluator. This check will ensure that the patient meets the study's eligibility criteria.
Each patient will be personally contacted by telephone by an evaluator to introduce the study and solicit their participation. During this contact, the patient will identify and provide, if desired, the contact information for their primary caregiver and the physician they designate as their primary decision-maker in the treatment and care of their cancer condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Rate of willingness of patients and their primary caregiver to communicate with each other and with the physician(s) about the patient's ACP.
时间窗: Baseline
Willingness to communicate about patients' ACP is assessed through a self-reported questionnaire created for the study and completed by the patients and their primary caregiver named "Willingness to communicate about the patient's ACP". The questionnaire is composed of 8 items regarding the willingness to communicate with each other and with the physician(s) about patients' planification of treatments, care, and the patient's prognosis. Each item has a 4 points Likert scale, ranging from "no" to "yes".
Rate of patients and their primary caregiver's advanced care wishes.
时间窗: Baseline
Advanced care wishes are assessed through a self-reported questionnaire created for the study and completed by the patients and their primary caregiver named "advanced care wishes". The questionnaire is composed of 12 items regarding advanced care preferences: participating in a clinical trial, receiving supportive care only, being resuscitated, being transferred to an intensive care unit. Each item has a 4 points Likert scale ranging from "no" to "yes".
Rate of patients and their primary caregiver's perceived self-efficacy to communicate with each other and with the physician(s) about the patient's ACP.
时间窗: Baseline
Perceived self-efficacy to communicate about the patient's ACP is assessed through a self-reported questionnaire created for the study and completed by the patients and their primary caregiver named "Perceived self-efficacy to communicate about the patient's ACP ". The questionnaire is composed of 4 items regarding the patient's and primary caregiver's perception of their efficacy to communicate with each other and with the physician(s) about patient's planification of treatments and care. Each item has a 4 points Likert scale ranging from "no" to "yes".
Rate of patients and their primary caregiver's barriers that prevent them from communicating with each other and with the physician(s) about the patient's ACP.
时间窗: Baseline
Barriers that prevent from communicating about the patient's ACP are assessed through a self-reported questionnaire created for the study and completed by the patients and their primary caregiver named "Barriers that prevent from communicating about the patient's ACP". The questionnaire is composed of 14 items regarding the potential barriers that prevent the patients and their primary caregiver from communicating with each other and with the physician(s) about the patient's planification of treatments and care: physical and/or psychological health, religious and/or philosophical beliefs, lack of time and/or availability of the physician(s). Each item has a 4 points Likert scale ranging from "no" to "yes".
次要结局
- Impact of patients and their primary caregiver's socio-demographic characteristics on their willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of the physician's socio-professional characteristics on patients' and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of patient's current functional status on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of medical factors on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of perception of the patient's medical situation on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of physician's communication about the patient's ACP on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of emotional distress on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of satisfaction with cancer care on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of Intolerance of Uncertainty on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of moral principles on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of decision-making preferences regarding medical decisions on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of physicians' perceived self-efficacy to communicate about the patient's ACP on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of physicians' perceived communication about patients' ACP on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of physicians' outcome expectancies regarding communication about patients' ACP on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of collusion between patient, their primary caregiver and the physician(s) on patient, their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of physician cognitive empathy on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of physicians' burn out on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of relational factors on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.(Baseline)
- Impact of perceived daily burden on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP(Baseline)