Clinical trial · Interventional
Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer
Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer: a Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Death | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Go-TAD | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Go-TAD
- description
- the participants will receive a medical visit that will include the 4 open-ended questions comprising the Go-TAD intervention
- interventionNames
- Other: Go-TAD
- type
- NO_INTERVENTION
- label
- CONTROL
- description
- the participants will receive a medical visit that will include the 4 open-ended questions comprising hobbies and other personal themes, but not death.
Primary outcomes (1)
- measure
- Emotional distress
- timeFrame
- 4 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
The inclusion criteria will be: 1. patients with advanced cancer defined according to ASCO (American Society of Clinical Oncology) criteria referred for the initial palliative care (PC) consultation. 2. age over 18 years 3. ECOG 0-3 (functionality status) 4. outpatients and inpatients 5. patients who can sign the informed consent 6. patients with the ability to maintain a conversation The exclusion criteria will be: 1. patients with acute symptoms that may affect their consciousness. 2. patients with any uncontrolled symptoms that prevent collaboration in the study assessed according to clinical judgment 3. moderate or severe cognitive impairment assessed according to clinical judgment 4. patients included in another incompatible clinical trial
References
Publications (7)
- BACKGROUNDLee JJ, Liu DD. A predictive probability design for phase II cancer clinical trials. Clin Trials. 2008;5(2):93-106. doi: 10.1177/1740774508089279. PMID 18375647
- BACKGROUNDLimonero JT, Mateo D, Mate-Mendez J, Gonzalez-Barboteo J, Bayes R, Bernaus M, Casas C, Lopez M, Sirgo A, Viel S. [Assessment of the psychometric properties of the Detection of Emotional Distress Scale in cancer patients]. Gac Sanit. 2012 Mar-Apr;26(2):145-52. doi: 10.1016/j.gaceta.2011.07.016. Epub 2011 Oct 26. Spanish. PMID 22033008
- BACKGROUNDMartin-Fernandez J, del Cura-Gonzalez MI, Gomez-Gascon T, Fernandez-Lopez E, Pajares-Carabajal G, Moreno-Jimenez B. [Patient satisfaction with the patient-doctor relationship measured using the questionnaire (PDRQ-9)]. Aten Primaria. 2010 Apr;42(4):196-203. doi: 10.1016/j.aprim.2009.09.026. Epub 2010 Feb 8. Spanish. PMID 20116893
- BACKGROUNDSerra-Prat M, Nabal M, Santacruz V, Picaza JM, Trelis J; Grupo Catalan de Estudio de la Efectividad de los Cuidados Paliativos. [Validation of the Spanish version of the Palliative Care Outcome Scale]. Med Clin (Barc). 2004 Oct 2;123(11):406-12. doi: 10.1016/s0025-7753(04)74535-2. Spanish. PMID 15482713
- RESULTCrespo I, Monforte-Royo C, Balaguer A, Pergolizzi D, Cruz-Sequeiros C, Luque-Blanco A, Porta-Sales J. Screening for the Desire to Die in the First Palliative Care Encounter: A Proof-of-Concept Study. J Palliat Med. 2021 Apr;24(4):570-573. doi: 10.1089/jpm.2020.0276. Epub 2020 Sep 18. PMID 32945714
- RESULTPorta-Sales J, Crespo I, Monforte-Royo C, Marin M, Abenia-Chavarria S, Balaguer A. The clinical evaluation of the wish to hasten death is not upsetting for advanced cancer patients: A cross-sectional study. Palliat Med. 2019 Jun;33(6):570-577. doi: 10.1177/0269216318824526. Epub 2019 Jan 28. PMID 30688146
- DERIVEDJulia-Torras J, Garcia-Salanova A, Monforte-Royo C, Jimeno Ariztia M, Balaguer A, Crespo I. Impact of proactively inviting people with advanced cancer to talk about the end of life: a randomised clinical trial protocol. BMJ Open. 2025 Jul 13;15(7):e104195. doi: 10.1136/bmjopen-2025-104195.