Clinical trial NCT05796947: From Active to Palliative Care: Emotional Burden and Self Efficacy in Patients and Caregivers
Official title: From Active to Palliative Care: Emotional Burden and Self Efficacy in Patients and Caregivers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End of Life
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients and caregivers declared "OLT/Off Therapy" for whom a suitable/eligible evaluation request is made by the clinicians to the UOC of Palliative Care (enrolled after clinical and psychological evaluations by the multidisciplinary team).

Brief summary: This study aims to evaluate psychological dimensions in patients and caregivers in the transition phase from active to palliative care.

Detailed description: After being informed about the study, all patient giving written informed consent will enrolled and evaluated at T0 through the General Self-Efficacy Scale (GSE), Resilience Scale (RS-14), Toronto Alexithymia Scale (TAS-20), Integrated Palliative Care Outcome Scale (IPOS) and Caregiver Inventory (CGI).

Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* Patients who are not undergoing active treatments (OLT)
* Suitability of the patient for palliative care
* Ability to express informed consent

Exclusion Criteria:

* Age \< 18 years
* Patient not eligible for palliative care (active treatments)
* Comorbidity factors that make enrollment impossible
* Inability to give informed consent
* Psychiatric disorders prior to the current pathology
* Severe speech impairment

Primary outcomes:
measure: Psychological assessment of Alexithymia domain in patient and caregiver
timeFrame: Test administred just once, at Time 0 (up to 5 days after the clinical decision about the suspension of active tratements, and subsequently activation of Palliative Care Unit consultation).
measure: Psychological assessment of caregiver's burden domain.
timeFrame: Test administred just once, at Time 0 (up to 5 days after the clinical decision about the suspension of active tratements, and subsequently activation of Palliative Care Unit consultation).
measure: Assessment of patient and caregiver self-efficacy domain.
timeFrame: Test administred just once, at Time 0 (up to 5 days after the clinical decision about the suspension of active tratements, and subsequently activation of Palliative Care Unit consultation).
measure: Psychological assessment of patient's burden domain.
timeFrame: Test administred just once, at Time 0 (up to 5 days after the clinical decision about the suspension of active tratements, and subsequently activation of Palliative Care Unit consultation).
Secondary outcomes:
measure: Assessment of patient and caregiver resilience domain.
timeFrame: Test administred just once, at Time 0 (up to 5 days after the clinical decision about the suspension of active tratements, and subsequently activation of Palliative Care Unit consultation).
measure: Psychological differences between patients with first diagnosis or disease recurrence in self efficacy (assessed by General Self-Efficacy Scale) and resilience (assessed by Resilience Scale) domains.
timeFrame: Test to patients are administred just once, at Time 0 (up to 5 days after the clinical decision about the suspension of active tratements, and subsequently activation of Palliative Care Unit consultation).
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Agostino Gemelli IRCCS
state: RM
Study officials:
References: