NCT06646315

Early Versus Standard Care in Cancer Patients in Phase 1 Clinical Trials

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Institut Català d'Oncologia · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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 and/or the social worker. The control group will receive the TAU, by which they will be only followed by their medical professional of reference

Conditions

• Emotional Adjustment

Interventions

Type	Name	Description
BEHAVIORAL	Early Intervention	The Early Intervention consists of the proper attention given to those patients who participate in a Phase I Clinical Trial. The attention will be based on a monthly assessment of their physical, psychological/emotional symptoms and, also their sociofamiliar needs. After having discussed patients's needs in a multidisciplinary committee, each professional (paliiative physician, clinical psychologist and/or wocial orker) will proportionate them the required attention in order to increase their quality of life.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-06-20
• Completion: 2024-09-30
• First posted: 2024-10-17
• Last updated: 2024-10-17

Locations

1 site across 1 country: Spain