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

NCT06420609 | Active Not Recruiting DMC

• 1 other identifier: PI22/01536
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Death; Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Other Outcomes (1)

• Clinical and sociodemographic variables

  4 days

Study Arms (2)

Go-TAD

EXPERIMENTAL

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

Other: Go-TAD

CONTROL

NO INTERVENTION

the participants will receive a medical visit that will include the 4 open-ended questions comprising hobbies and other personal themes, but not death.

Interventions

Go-TAD OTHER

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

Go-TAD

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead
• Institut Català d'Oncologia: collaborator
• Hospital Arnau de Vilanova: collaborator
• Fundacion Rioja Salud: collaborator

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Related Publications (7)

• 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.

  PMID: 18375647 BACKGROUND

• 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.

  PMID: 22033008 BACKGROUND

• 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.

  PMID: 20116893 BACKGROUND

• 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.2020.0276. Epub 2020 Sep 18.

  PMID: 32945714 BACKGROUND

• 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.

  PMID: 15482713 BACKGROUND

• 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: 10.1177/0269216318824526. Epub 2019 Jan 28.

  PMID: 30688146 BACKGROUND

• Julia-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.

  PMID: 40659391 DERIVED

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: May 14, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 21, 2025
• Last Updated: April 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)