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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
186
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.
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain
Psyhsical symptoms
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.
Time frame: Three months
Psychosocial symptoms and needs
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.
Time frame: Three months
Sociofamiliar needs
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?
Time frame: Three months
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