Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420609
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-14
Brief Title:
Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer
Sponsor:
Universitat Internacional de Catalunya
Organization:
Universitat Internacional de Catalunya
Study Overview
Official Title:
Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Go-TAD
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None