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

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Status: Not yet enrolling

Conditions: Cancer; Palliative Care

Treatments: Other: Nurse-led telephonic calls

Study type: Interventional

Funder types: Other

Identifiers

NCT05434208

IRST100.57

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Other: Nurse-led telephonic calls

B CONTROL GROUP: face-to-face visit at end of treatment

No Intervention group

Description:

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