Clinical trial NCT06420609: Efficacy of a Proactive Approach to Death Thoughts in People with Advanced Cancer
Official title: Efficacy of a Proactive Approach to Death Thoughts in People with Advanced Cancer: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Death
Advanced Cancer
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
Collaborators: name: Institut Català d'Oncologia
name: Hospital Arnau de Vilanova
name: Fundacion Rioja Salud
First posted: 2024-05-20
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Emotional distress
timeFrame: 4 days
Secondary outcomes:
measure: Hopelessness assessed by the Beck Hopelessness Questionnaire (BHQ).
timeFrame: 4 days
measure: Doctor-patient relationship evaluated with the Patient-Doctor-Relationship Questionnaire -PDRQ-9-.
timeFrame: 4 days
measure: Quality of life related to health evaluated using the Palliative Outcome Scale (POS)
timeFrame: 4 days
Other outcomes:
measure: Clinical and sociodemographic variables
timeFrame: 4 days
Locations:
city: Sant Cugat del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References:
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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: 10.1177/0269216318824526. Epub 2019 Jan 28.