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

NCT ID: NCT05434208

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2025-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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 IPOS
• Questionnaire: FAMCARE-2 for CGs

Group Type: EXPERIMENTAL

Nurse-led telephonic calls

Intervention Type: OTHER

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

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 IPOS
• Questionnaire: FAMCARE-2 for CGs

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nurse-led telephonic calls

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa Valenti, Nurse

Role: STUDY_CHAIR

IRCCS IRST

Locations

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

Meldola, Forlì-Cesena, Italy

Countries

Italy

Central Contacts

Vanessa Valenti

Role: CONTACT

vanessa.valenti@irst.emr.it

+39 0543 739998

Centro di Coordinamento Studi IRST

Role: CONTACT

cc.ubsc@irst.emr.it

+39 0544 285075

Facility Contacts

Vanessa Valenti, Nurse

Role: primary

Other Identifiers

IRST100.57

Identifier Type: -

Identifier Source: org_study_id