Effects of Nurse-led Telephone Based Service for Early Palliative Care (PALTEL) (PALTEL)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Palliative Care
• Intervention / Treatment: Other: Nurse-led telephonic calls

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vanessa Valenti; Phone Number: +39 0543 739998; Email: vanessa.valenti@irst.emr.it
• Study Contact Backup: Name: Centro di Coordinamento Studi IRST; Phone Number: +39 0544 285075; Email: cc.ubsc@irst.emr.it

Study Locations

• Italy
  • Forlì-Cesena
    • Meldola, Forlì-Cesena, Italy, 47014
      • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.
      • Contact: Vanessa Valenti, Nurse

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A RESEARCH ARM: active telephonic follow-up by specialist nurse; 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 IPOSQuestionnaire: FAMCARE-2 for CGs	Other: Nurse-led telephonic calls; active telephonic follow-up program by specialist nurses until end-of-treatment (28 days)
No Intervention: B CONTROL GROUP: face-to-face visit at end of treatment; 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 IPOSQuestionnaire: FAMCARE-2 for CGs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 years
Number of hospital referrals	Number of home care and hospital referrals in group A and B	3 years
Patients' access to the local Palliative care network	Mean number of days in home care and hospital in group A and B	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.	3 years

Collaborators and Investigators

• Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Investigators: Study Chair: Vanessa Valenti, Nurse, IRCCS IRST

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Early Palliative Care
• Other Study ID Numbers: IRST100.57

Drug and device information, study documents

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