Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT04165460
Eligibility Criteria:
Inclusion Criteria:
* PATIENTS:
* Affiliated to the MICAELA (Modelo Integral para el Cáncer Cervicouterino Localmente Avanzado y Avanzado) program
* Ability to understand the study and to provide signed informed consent
* Diagnosed with locally advanced and advanced cervical cancer
* Patients newly diagnosed or with recurrence about to start treatment
* Patients with moderate or severe anxiety, and/or depression symptoms or maladaptive coping
* PRIMARY CAREGIVERS:
* Relatives, acquaintance or friends reported to be the principal caregiver of the patient
* Relatives, acquaintance or friends who do not perceived economic remuneration for taking care of the patient
Exclusion Criteria:
* PATIENTS:
* Patients with psychological or psychiatric treatment or who received previous mental-health treatment.
* Patients with any alteration of the Central Nervous System
* Patients with moderated or severe cognitive impairment
* Patients under palliative care or in terminal phase
* PRIMARY CAREGIVERS
* Caregivers with severe hearing and/or visual problems
* Caregivers with a professional or technical training in patient care
Elimination criteria Patients referred to palliative care
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04165460
Study Brief:
Protocol Section:
NCT04165460