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

Advanced Cancer Clinical Trial

— Go-TAD  

Official title:

Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer: a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420609
• Other study ID #: PI22/01536
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: December 21, 2025

Study information

• Verified date: May 2024
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: December 21, 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Death
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya	Fundacion Rioja Salud, Hospital Arnau de Vilanova, Institut Català d'Oncologia

References & Publications (6)

Crespo 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 — View Citation

Lee JJ, Liu DD. A predictive probability design for phase II cancer clinical trials. Clin Trials. 2008;5(2):93-106. doi: 10.1177/1740774508089279. — View Citation

Limonero 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. — View Citation

Martin-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. — View Citation

Porta-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: 10.117 — View Citation

Serra-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical and sociodemographic variables	age, gender, marital status, type of cancer, months since diagnosis.	4 days
Primary	Emotional distress	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.	4 days
Secondary	Hopelessness assessed by the Beck Hopelessness Questionnaire (BHQ).	Hopelessness will be assessed with the Beck Hopelessness Questionnaire (BHQ). This validated and widely used questionnaire in palliative care research originally consists of 20 items that were reduced to 7 items with true/false responses in a brief version specially adapted to the area of palliative care. The total score ranges from 0 to 7, with higher scores indicating a higher level of hopelessness.	4 days
Secondary	Doctor-patient relationship evaluated with the Patient-Doctor-Relationship Questionnaire -PDRQ-9-.	The quality of the doctor-patient relationship from the patient's perspective will be evaluated with the Patient-Doctor-Relationship Questionnaire -PDRQ-9-. This questionnaire consists of 9 items with a 5-point Likert-type response format and has been previously used in the field of palliative care. The total score ranges between 9-45, with higher scores indicating a better relationship between doctor and patient.	4 days
Secondary	Quality of life related to health evaluated using the Palliative Outcome Scale (POS)	It will be evaluated using the Palliative Outcome Scale (POS). This scale has been validated with a proxy for quality of life in patients with palliative care. It consists of 12 items with multiple response format that address the physical and psychological dimensions, the information given, communication with family and friends, the meaning of life and other practical aspects related to the disease. The range of scores is 0-40, with higher scores indicating worse quality of life.	4 days