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Trial Title:
Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer
NCT ID:
NCT06420609
Condition:
Death
Advanced Cancer
Conditions: Official terms:
Neoplasms
Death
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Masking description:
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.
Intervention:
Intervention type:
Other
Intervention name:
Go-TAD
Description:
The participants will receive a medical visit that will include the 4 open-ended
questions comprising the Go-TAD intervention
Arm group label:
Go-TAD
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Start date:
May 14, 2024
Completion date:
December 21, 2025
Lead sponsor:
Agency:
Universitat Internacional de Catalunya
Agency class:
Other
Collaborator:
Agency:
Institut Català d'Oncologia
Agency class:
Other
Collaborator:
Agency:
Hospital Arnau de Vilanova
Agency class:
Other
Collaborator:
Agency:
Fundacion Rioja Salud
Agency class:
Other
Source:
Universitat Internacional de Catalunya
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06420609
