End of LifeCACPNCT05796947
From Active to Palliative Care: Emotional Burden and Self Efficacy in Patients and Caregivers
An observational study of End of Life, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This study aims to evaluate psychological dimensions in patients and caregivers in the transition phase from active to palliative care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End of Life
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 5 May 2022to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Daniela Belella contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Agostino Gemelli IRCCS
Roma, RM, 00168
Letizia Lafuenti, 00390630156280, letizia.lafuenti1@policlinicogemelli.it
About this study
This study aims to evaluate psychological dimensions in patients and caregivers in the transition phase from active to palliative care.
Read the 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).
- Conditions
- End of Life
- Medical subject headings
- Death
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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 (2)
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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start5 May 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End of LifeStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796947
- Sponsor's protocol ID
- 4776
- Acronym
- CACP
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Active to Palliative Care: Emotional Burden and Self Efficacy in Patients and Caregivers
- ClinicalTrials.gov ID
- NCT05796947
- Acronym / sponsor ID
- CACP / 4776
- Conditions
- End of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychological assessment of Alexithymia domain in patient and caregiver
Time frame: 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 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.
Psychological assessment of caregiver's burden domain.
Time frame: 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 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.
Assessment of patient and caregiver self-efficacy domain.
Time frame: 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).
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.
Psychological assessment of patient's burden domain.
Time frame: 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 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).
2 secondary outcomes
Assessment of patient and caregiver resilience domain.
Time frame: 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.
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Belella contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End of Life, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Letizia Lafuenti (00390630156280, letizia.lafuenti1@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological assessment of Alexithymia domain in patient and caregiver (time frame: 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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.