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

NCT05434208 | Unknown

• 1 other identifier: IRST100.57
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Palliative Care; Cancer

Keywords

Early Palliative Care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• FAMCARE-2

  3 years

• Use of healthcare services

  3 years

• Number of hospital referrals

  3 years

• Patients' access to the local Palliative care network

  3 years

• Intervention of Palliative Care Outpatient Clinic

  3 years

Study Arms (2)

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

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

Interventions

Nurse-led telephonic calls OTHER

active telephonic follow-up program by specialist nurses until end-of-treatment (28 days)

A RESEARCH ARM: active telephonic follow-up by specialist nurse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (1)

IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.

Meldola, Forlì-Cesena, 47014, Italy

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Vanessa Valenti, Nurse

  IRCCS IRST

  STUDY CHAIR

Central Study Contacts

Vanessa Valenti

CONTACT

+39 0543 739998; vanessa.valenti@irst.emr.it

Centro di Coordinamento Studi IRST

CONTACT

+39 0544 285075; cc.ubsc@irst.emr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 27, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

IT (1)