Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Emotional distress
研究概览
简要总结
The aim of this study is to demonstrate the efficacy of a proactive intervention to approach death thoughts among people with advanced cancer compared to usual care (the reactive approach) via a feasible approach with previous indicators of efficacy: Go-TAD (Give the Opportunity to Talk about Death). The benefits of the intervention will be evaluated in terms of: reduction of emotional distress and hopelessness and improvement the doctor-patient relationship, as well as improvement of quality of life for the patient. A Phase II randomized controlled mixed methods clinical trial (RCT) will be carried out within 4 Palliative Care units of tertiary care hospitals in Catalonia. Participants will be persons with advanced cancer defined according to the criteria of the American Society of Clinical Oncology. Participants will be randomly assigned to an intervention group or control group. In the intervention group, the participants will receive a medical visit that will include the 4 open-ended questions comprising the Go-TAD intervention, while the control group will receive usual care. Between 24 and 96 hours later, a researcher from outside the center will assess study outcome measures. To strengthen the study conclusions, a qualitative study will be carried out in which the experiences of the participants in the intervention group and of their professionals who administered the Go-TAD will be explored in depth.
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
- Single (Participant)
盲法说明
This study proposes a randomized controlled clinical trial (RCT) with a stepped-wedge design, in which 6 palliative care units from second and third level hospitals in Spain will collaborate. The six units will contribute with both experimental and control participants, starting with the recruitment of the control group participants and subsequently starting the intervention group. The time at which they will transition to the intervention will be chosen at random. The centers will be randomized to know at what point in the study they should begin the intervention and each center will be informed of the number of patients they should include in each of the groups. The clusters correspond to the different palliative care units that participate in the study. Six sequences will be carried out, seven periods with 4 patients in each period. Patients will be different in each of the periods.
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
- •The inclusion criteria will be:
- •patients with advanced cancer defined according to ASCO (American Society of Clinical Oncology) criteria referred for the initial palliative care (PC) consultation.
- •age over 18 years
- •ECOG 0-3 (functionality status)
- •outpatients and inpatients
- •patients who can sign the informed consent
- •patients with the ability to maintain a conversation
排除标准
- •patients with acute symptoms that may affect their consciousness.
- •patients with any uncontrolled symptoms that prevent collaboration in the study assessed according to clinical judgment
- •moderate or severe cognitive impairment assessed according to clinical judgment
- •patients included in another incompatible clinical trial
研究组 & 干预措施
Go-TAD
the participants will receive a medical visit that will include the 4 open-ended questions comprising the Go-TAD intervention
干预措施: Go-TAD (Other)
CONTROL
the participants will receive a medical visit that will include the 4 open-ended questions comprising hobbies and other personal themes, but not death.
结局指标
主要结局
Emotional distress
时间窗: 4 days
The main outcome will be emotional distress, which will be evaluated using an instrument validated and developed in the context of palliative care in Spain, the Emotional Distress Detection (DME) questionnaire. This questionnaire is characterized by the simplicity and ease of application and the short application time, given that it only consists of 4 items. The first three items are questions with answers in the format of a visual numerical scale from 0 to 10, in which the state of mind and the perception of coping with the situation are evaluated, and another that records the presence or absence of concerns. The last question is based on the observation, by the healthcare professional, of the presence of external signs of emotional distress. The DME gives a total score (0 to 20) made up of the sum of the scores of the first three items, one of them in reverse format, with the highest scores indicating greater discomfort.
次要结局
- Hopelessness assessed by the Beck Hopelessness Questionnaire (BHQ).(4 days)
- Doctor-patient relationship evaluated with the Patient-Doctor-Relationship Questionnaire -PDRQ-9-.(4 days)
- Quality of life related to health evaluated using the Palliative Outcome Scale (POS)(4 days)
研究者
Iris Crespo Martin
Principal investigator
Universitat Internacional de Catalunya