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

Plain-language 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

Who can participate

What they're measuring

Trial details