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

NCT ID: NCT06646315

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Early intervention

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).

Group Type: EXPERIMENTAL

Early Intervention

Intervention Type: 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.

TAU

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early Intervention

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Català d'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Barcelona, Spain

Countries

Spain

Other Identifiers

pr081/20

Identifier Type: OTHER

Identifier Source: secondary_id

Psico UFF1

Identifier Type: -

Identifier Source: org_study_id