Clinical trial NCT05434208: Effects of Nurse-led Telephone Based Service for Early Palliative Care (PALTEL)
Official title: Effects of Nurse-led Telephone Based Service for Early Palliative Care Patients With Advanced Cancer: the Paltel Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Palliative Care
Cancer
Keywords: Early Palliative Care
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Edmonton Symptoms Assessments System (ESAS)
timeFrame: 3 years
measure: Italian Integrated Palliative Care Outcome Scale (IPOS)
timeFrame: 3 years
Secondary outcomes:
measure: FAMCARE-2
timeFrame: 3 years
measure: Use of healthcare services
timeFrame: 3 years
measure: Number of hospital referrals
timeFrame: 3 years
measure: Patients' access to the local Palliative care network
timeFrame: 3 years
measure: Intervention of Palliative Care Outpatient Clinic
timeFrame: 3 years
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
state: Forlì-Cesena
Study officials:
affiliation: IRCCS IRST
name: Vanessa Valenti, Nurse
role: STUDY_CHAIR
References: