Palliative CarePALTELNCT05434208
Effects of Nurse-led Telephone Based Service for Early Palliative Care (PALTEL)
A study testing Nurse-led telephonic calls in people with Palliative Care and Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
Trial summary
Non-pharmacological, interventional, two-arm, randomized controlled trial. Early Palliative Care cancer patients will be randomized to active telephonic follow-up program by specialist nurses until end-of-treatment (28 days) (group A, research arm) or face-to-face visit at end of treatment (28 days) (group B, control… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Cancer
- What is being tested?
- Nurse-led telephonic calls
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2022to Sep 2025
- Phase
- Interventional
- 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
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study;
- Patients having a defined Caregiver
- Cancer patients referred for the first time to the Early Palliative Care Outpatient Clinic;
- Both Female or Male, aged ≥ 18 years;
- Italian speaking patients.
Who cannot join
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 3 or higher
- Patients cognitively impaired or deaf;
- Patients not having a telephone or not capable of speaking/using a telephone;
- Patients referred to palliative Homecare or Hospice at the first visit Early Palliative Care Outpatient Clinic.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
Meldola, Forlì-Cesena, 47014
Vanessa Valenti, Nurse
About this study
Official title: Effects of Nurse-led Telephone Based Service for Early Palliative Care Patients With Advanced Cancer: the Paltel Randomized Controlled Trial
Non-pharmacological, interventional, two-arm, randomized controlled trial. Early Palliative Care cancer patients will be randomized to active telephonic follow-up program by specialist nurses until end-of-treatment (28 days) (group A, research arm) or face-to-face visit at end of treatment (28 days) (group B, control arm).
There are few studies demonstrating the efficacy of nurse-led telephone service in advanced cancer patients but it's still quite unclear how they can affect quality of life, symptom burden and caregivers distress. In addition, the ideal structure, method and timing of telephone follow-up as well are often not considered and have not been articulated. Nurse-led management by phone to advanced cancer patients could, for some patients, dramatically improve their care experience, quality of life and symptoms control.
Investigators want to build an effective and sustainable approach for implementing the telephone service providing nurse-led telephone-based support to Early Palliative Care cancer patients. The aim is to investigate the feasibility of a proactive approach and measure the efficacy in terms of symptom management, satisfaction with care and impact on health care resources.
- Conditions
- Palliative Care, Cancer
- Being tested
- Nurse-led telephonic calls
- Keywords
- Early Palliative Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led telephonic callsOther
active telephonic follow-up program by specialist nurses until end-of-treatment (28 days)
| Study group | Role | What they receive |
|---|---|---|
| A RESEARCH ARM: active telephonic follow-up by specialist nurse | Experimental | Early Palliative Care cancer patients will be randomized to active telephonic follow-up program by specialist nurses until end-of-treatment (28 days)
* Scheduled phone-calls each 7 days from T0 + unscheduled phone-calls (as needed)
* Questionnaire: ESAS and IPOS;
* Weight;
* Medication intake;
* ECOG-PS
* Scheduled phone-calls at End of Treatment (28 days from T0):
* Questionnaire: ESAS and IPOS
* Questionnaire: FAMCARE-2 for CGs Receives: Other: Nurse-led telephonic calls |
| B CONTROL GROUP: face-to-face visit at end of treatment | No intervention | Early Palliative Care cancer patients will be randomized to face-to-face visit at end of treatment (28 days) * Unscheduled phone-calls, on patients initiative: * Questionnaire: ESAS and IPOS; * Weight; * Medication intake; * ECOG-PS * Face-to-face visit at End of Treatment (28 days from T0): * Questionnaire: ESAS and IPOS * Questionnaire: FAMCARE-2 for CGs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edmonton Symptoms Assessments System (ESAS)
ESAS is a questionnaire to rate common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, with 0 meaning that the symptom is absent and 10 that it is the worst possible severity (total score 0-90).
Measured: 3 years
Italian Integrated Palliative Care Outcome Scale (IPOS)
The IPOS is a patient-reported outcome measures, valid and reliable both in patient self-report and staff proxy-report versions to assess and monitor symptoms and concerns in advanced illness, determine the impact of healthcare interventions, and demonstrate quality of care.
Measured: 3 years
Secondary outcomes (5)
FAMCARE-2
The FAMCARE-2 scale includes 17 items and measures caregivers satisfaction with care received by both patent and caregivers with the following four components of care: management of physical symptoms and comfort, provision of information, family support, and patient psychological care. Each item is rated according to a 5-point Likert scale (5=very satisfied - 1=very dissatisfied). The score range is between 17 and 85: high scores indicate high levels of satisfaction with care.
Measured: 3 years
Use of healthcare services
Number of unscheduled hospital admissions, emergency department visits, face-to-face visit in early Palliative Care Outpatient Clinic, unscheduled phone-calls to Palliative Care telephone service for patients or caregivers needs and unscheduled visits in oncological day-hospital. All this data will be collected at End of Study using patients' medical records.
Measured: 3 years
Number of hospital referrals
Number of home care and hospital referrals in group A and B
Measured: 3 years
Patients' access to the local Palliative care network
Mean number of days in home care and hospital in group A and B
Measured: 3 years
Intervention of Palliative Care Outpatient Clinic
Collection of the reasons that led the oncologist to request the intervention of the Palliative Care Outpatient Clinic and categorization of each reson in the subset agreed by international panel on Lancet.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Valenti, Nurse, Study chair, IRCCS IRST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434208
- Sponsor's protocol ID
- IRST100.57
- Acronym
- PALTEL
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nurse-led Telephone Based Service for Early Palliative Care Patients With Advanced Cancer: the Paltel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05434208
- Acronym / sponsor ID
- PALTEL / IRST100.57
- Conditions
- Palliative Care, Cancer
- Keywords
- Early Palliative Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 27 Jun 2022 (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.
Non-pharmacological, interventional, two-arm, randomized controlled trial. Early Palliative Care cancer patients will be randomized to active telephonic follow-up program by specialist nurses until end-of-treatment (28 days) (group A, research arm) or face-to-face visit at end of treatment (28 days) (group B, control arm).
There are few studies demonstrating the efficacy of nurse-led telephone service in advanced cancer patients but it's still quite unclear how they can affect quality of life, symptom burden and caregivers distress. In addition, the ideal structure, method and timing of telephone follow-up as well are often not considered and have not been articulated. Nurse-led management by phone to advanced cancer patients could, for some patients, dramatically improve their care experience, quality of life and symptoms control.
Investigators want to build an effective and sustainable approach for implementing the telephone service providing nurse-led telephone-based support to Early Palliative Care cancer patients. The aim is to investigate the feasibility of a proactive approach and measure the efficacy in terms of symptom management, satisfaction with care and impact on health care resources.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A RESEARCH ARM: active telephonic follow-up by specialist nurse | Experimental | Other: Nurse-led telephonic callsEarly Palliative Care cancer patients will be randomized to active telephonic follow-up program by specialist nurses until end-of-treatment (28 days) * Scheduled phone-calls each 7 days from T0 + unscheduled phone-calls (as needed) * Questionnaire: ESAS and IPOS; * Weight; * Medication intake; * ECOG-PS * Scheduled phone-calls at End of Treatment (28 days from T0): * Questionnaire: ESAS and IPOS * Questionnaire: FAMCARE-2 for CGs |
| B CONTROL GROUP: face-to-face visit at end of treatment | No intervention | –Early Palliative Care cancer patients will be randomized to face-to-face visit at end of treatment (28 days) * Unscheduled phone-calls, on patients initiative: * Questionnaire: ESAS and IPOS; * Weight; * Medication intake; * ECOG-PS * Face-to-face visit at End of Treatment (28 days from T0): * Questionnaire: ESAS and IPOS * Questionnaire: FAMCARE-2 for CGs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the study;
- Patients having a defined Caregiver
- Cancer patients referred for the first time to the Early Palliative Care Outpatient Clinic;
- Both Female or Male, aged ≥ 18 years;
- Italian speaking patients.
Key exclusion criteria (4 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 3 or higher
- Patients cognitively impaired or deaf;
- Patients not having a telephone or not capable of speaking/using a telephone;
- Patients referred to palliative Homecare or Hospice at the first visit Early Palliative Care Outpatient Clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led telephonic callsactive telephonic follow-up program by specialist nurses until end-of-treatment (28 days) | Other | A RESEARCH ARM: active telephonic follow-up by specialist nurse |
Primary outcome
Edmonton Symptoms Assessments System (ESAS)
Time frame: 3 years
ESAS is a questionnaire to rate common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, with 0 meaning that the symptom is absent and 10 that it is the worst possible severity (total score 0-90).
Italian Integrated Palliative Care Outcome Scale (IPOS)
Time frame: 3 years
The IPOS is a patient-reported outcome measures, valid and reliable both in patient self-report and staff proxy-report versions to assess and monitor symptoms and concerns in advanced illness, determine the impact of healthcare interventions, and demonstrate quality of care.
5 secondary outcomes
FAMCARE-2
Time frame: 3 years
Use of healthcare services
Time frame: 3 years
Number of hospital referrals
Time frame: 3 years
Patients' access to the local Palliative care network
Time frame: 3 years
Intervention of Palliative Care Outpatient Clinic
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
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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.
Vanessa Valenti, Nurse study chair
IRCCS IRST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led telephonic calls in people with Palliative Care and Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. 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 5 inclusion and 4 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 27 Jun 2022. 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 Vanessa Valenti (+39 0543 739998, vanessa.valenti@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edmonton Symptoms Assessments System (ESAS) (time frame: 3 years). The study lists 2 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 27 Jun 2022.