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

Cancer Clinical Trial

— PALTEL  

Official title:

Effects of Nurse-led Telephone Based Service for Early Palliative Care Patients With Advanced Cancer: the Paltel Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05434208
• Other study ID #: IRST100.57
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: September 2025

Study information

• Verified date: June 2022
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: Vanessa Valenti
• Phone: +39 0543 739998
• Email: vanessa.valenti[@]irst.emr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: September 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Palliative Care

Intervention

Other:
• Nurse-led telephonic calls
active telephonic follow-up program by specialist nurses until end-of-treatment (28 days)

Locations

Country	Name	City	State
Italy	IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.	Meldola	Forlì-Cesena

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Number of hospital referrals	Number of home care and hospital referrals in group A and B	3 years
Secondary	Patients' access to the local Palliative care network	Mean number of days in home care and hospital in group A and B	3 years
Secondary	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