Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646315
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Early Versus Standard Care in Cancer Patients in Phase 1 Clinical Trials
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Versus Standard Care in Cancer Patients in Phase 1 Clinical Trials
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Psico UFF1
Brief Summary:
The goal of this clinical trial is to test de feasibility and effectiveness of and early psychosocial and symptoms attention in cancer patients participating in a Phase I Clinical Trial The main question it aims to answer is the following Is an early psychosocial and palliative care attention effective to reduce psychosocial and physical symptoms among participants included in a Phase I Clinical Trial All participants will answer a questionnaire including the Spanish version of the ESAS Carvajal García y Centeno 2013 the ENP-E Mateo-Ortega et al 2019 and two adhoc sociofamiliar-oriented questions The assessments will take place just before entering the Phase I Clinical Trial treatment T0 and one-time per month for three consecutive months T1-T3 Researchers will compare questionnaire responses of the early-attention group and the control group The assessment responses from the early-attention group will be monthly discussed in a multidisciplinary committee just after each assessment and these will receive the attention according to their needs either by the palliative professional the clinical psychologist andor the social worker The control group will receive the TAU by which they will be only followed by their medical professional of reference
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None