Clinical trial NCT06646315: Early Versus Standard Care in Cancer Patients in Phase 1 Clinical Trials
Official title: Early Versus Standard Care in Cancer Patients in Phase 1 Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Adjustment
Keywords: Phase I Clinical Trial
Symptoms control
Psychosocial attention
Emotional distress
Sociofamiliar attention
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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


Eligibility criteria: Inclusion Criteria:

* Outpatients with a diagnosis of cancer, under outpatient oncological treatment and follow-up in a Phase 1 clinical trial.
* Having the functional capacity to respond to the study's evaluation measures.

Exclusion Criteria:

* Patients with physical limitations, with severe major depression, significant self-harm ideation, who present symptoms of psychosis or substance abuse, or with difficulty answering the questions of the study's evaluative measures, either due to language issues or due to the presence of cognitive impairment.
* Patients who, at the time of being recruited to start the Phase I clinical trial, are being cared for by one of the following three service: Psycho-oncology, Social Work and Palliative Care, or have been cared for by such services during the last 6 months.

Primary outcomes:
measure: Psyhsical symptoms
timeFrame: Three months
measure: Psychosocial symptoms and needs
timeFrame: Three months
measure: Sociofamiliar needs
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Català d'Oncologia
state: Barcelona
Study officials:
References: