From Active to Palliative Care: Emotional Burden and Self Efficacy in Patients and Caregivers (CACP)

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

Study Overview

• Status: Recruiting
• Conditions: End of Life

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).

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Letizia Lafuenti; Phone Number: 00390630156280; Email: letizia.lafuenti1@policlinicogemelli.it
• Study Contact Backup: Name: Daniela Belella; Email: daniela.belella@policlinicogemelli.it

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Agostino Gemelli IRCCS
      • Contact: Letizia Lafuenti; Phone Number: 00390630156280; Email: letizia.lafuenti1@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological assessment of Alexithymia domain in patient and caregiver	Assessment of the emotional state of patient and caregiver at the time of transition from active care to palliative care. The evaluation will be done by Toronto Alexithymia Scale, TAS-20 (G.J. Taylor, R.M. Bagby, J.D.A. Parker, 1992) to measure patient's and caregiver's ability to explore and share emotions. TAS-20 is a self-assessment questionnaire on alexithymia. It provides a total score, and the score of three dimensions that define the construct of Alexithymia: difficulty in identifying feelings, difficulty in communicating feelings to others and externally oriented thinking (operative thinking). It consists of 20 items measured on a five-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). A total score ranging from 20 to 100 is measured, plus three scores relating to the three dimensions of alexithymia. Clinical cut-off is from 60 to 100.	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).
Psychological assessment of caregiver's burden domain.	Assessment of the caregiver burden at the time of transition from active care to palliative care. Assessment will be done by the following instrument: - Caregiver Inventory, CGI-I (S. Serpentini et al., 2021) to measure the caregiver's burden. It is a self-report tool for assessing the caring burden, it measures the self-efficacy of the caregiver in different aspects of caregiving such as managing medical information, taking care of the patient, take care of ownself and manage difficult interactions/emotions. The scoring scale is a Likert-type scale with a ranging from 1 (not at all confident) to 9 points (totally confident). Range scoring is from 9 to 189. The higher the score, the higher will be the caregiver's emotional and care burden.	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).
Assessment of patient and caregiver self-efficacy domain.	Analysis of the results of the General Self-Efficacy Scale (GSE). It is a 10-item self-report psychometric scale that aims to measure the level of perceived self-efficacy to face the difficulties that life presents. It is a 5-point Likert-type scale. Score range is between 10 and 50, higher scores mean higher levels of perceived self efficay.	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).
Psychological assessment of patient's burden domain.	Assessment of the patient's burden at the time of transition from active care to palliative care. Assessment will be done by the following instrument: - Italian Integrated Palliative Outcome Scale (IPOS): widely used as a measure of patient-reported outcome. IPOS studies patients' primary concerns: common symptoms, patient and family distress, existential well-being, sharing feelings with family, information received, and practical concerns. IPOS includes 10 symptoms and 7 questions about emotional situations, spiritual concerns, and provision of information and support. Five answer options are possible for each question (score from 0 to 4; higher scores indicate greater burden). The overall IPOS score is the sum of the scores for each of the 17 questions. The overall IPOS score can therefore range from 0 to 68 (80 if the patient adds the three additional symptoms to the proposed list).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of patient and caregiver resilience domain.	Analysis of the results of the Resilience Scale (RS-14). This scale has got 14 items. It is a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree) for each item. Higher scores mean higher levels of resilience tendency. Minimum score:14, maximum score: 98. Clinical Cut-Off: < 56 very low resilience; 57 to 64: low resilience; 65 to 73: adeguate resilience; 74 to 81: moderate resilience; 82 to 90: high resilience; < 91: very high resilience.	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).
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.	Evaluation of any differences between the examined psychological domains for patients with a first diagnosis or with disease recurrence. Correlation between outcomes in the two groups (first diagnosis vs recurrence) will be done at the end of the study by statistical analisys between variables.	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).

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): May 30, 2024

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: 4776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No