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

NCT06646315 | Completed

• 2 other identifiers: Psico UFF1pr081/20
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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

Conditions

Emotional Adjustment

Keywords

Phase I Clinical Trial; Symptoms control; Psychosocial attention; Emotional distress; Sociofamiliar attention

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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?

  Three months

Study Arms (2)

Early intervention

EXPERIMENTAL

Participants will be assessed using ESAS, ENP and adhoc sociofamiliar questions just before entering their Phase I Clinical Trial (T0). Responses of this assessment will be discussed in a multidisciplinary committee comprised of a palliative physician, a clinical psychologist, a social worker, an oncologist, an hematologist and the Phase 1 Unit referent nurse. According to the patient responses, the committee will decide which needs will be addressed and this will be cited to the corresponding professional (palliative, psychologist and/or social worker) within the following 15 days. The same cycle (assessment - committee - attention) will take place a month after the T0 (T1), and during the following 2 other months (T2 and T3).

Behavioral: Early Intervention

TAU

NO INTERVENTION

Participants will be assessed using ESAS, ENP and adhoc sociofamiliar questions just before entering their Phase I Clinical Trial (T0), one month after (T1), two months after (T2) and three months after (T3).

Interventions

Early Intervention BEHAVIORAL

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.

Early intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Català d'Oncologia: lead

Study Sites (1)

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: December 1, 2022
• Primary Completion: June 20, 2024
• Study Completion: September 30, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)