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

Not Applicable

Completed

• Conditions: Emotional Adjustment

• Registration Number: NCT06646315
• Lead Sponsor: Institut Català d'Oncologia

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2024-06-20
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Psyhsical symptoms	Three months	Physical and psychosocial symptoms will be assessed using the ESAS (Edmonton Symptoms Assessment Scale). This scale assesses, using a 10-point Likert scale, the intensity of the following symptoms: pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep, and feeling of wellbeing.
Psychosocial symptoms and needs	Three months	Psychosocial symptoms will be assessed using the ENP-E (Psychosocial and Spiritual Needs Evaluation Scale). This scale assesses, using a 5-point Likert Scale the following dimensions: mood, sadness, feeling nervous, bearability of the situation, sharing the illness with the family, need for more information about the disease, feeling cared for and supported by family and friends, satisfaction with life, feeling in peace, meaning in life, presence of values and beliefs to cope with the situation, level of well-being. Also, the tool explores economic, family, emotional, spiritual and physical concerns, together to signs of emotional distress.
Sociofamiliar needs	Three months	Sociofamiliar needs of patients will be assessed using the following ad-hoc questions: In the family unit, are there minors, disabled people or other people who require attention? (e.g.: elderly people with chronic disease).; Is your habitual residence at such a geographical distance that it entails special needs? Is there a caregiver available? In addition to the disease, do you have any other health problem that limits your day-to-day life? Do you feel capable of sharing the process of the illness with your family? Would you need professional guidance/advice for aspects related to employment procedures, resources, benefits, housing needs, financial aid?

Trial Locations

Locations (1)

Institut Català d'Oncologia; 🇪🇸 L'Hospitalet De Llobregat, Barcelona, Spain