Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Go-TAD: The participants will receive a medical visit that will include the 4 open-ended questions comprising the Go-TAD intervention

Study summary

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.

Eligibility

Primary outcome measure(s)

• Emotional distress — 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.

Trial sites (1)

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