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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
140
active telephonic follow-up program by specialist nurses until end-of-treatment (28 days)
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
Meldola, Forlì-Cesena, Italy
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).
Time frame: 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.
Time frame: 3 years
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.
Time frame: 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.
Time frame: 3 years
Number of hospital referrals
Number of home care and hospital referrals in group A and B
Time frame: 3 years
Patients' access to the local Palliative care network
Mean number of days in home care and hospital in group A and B
Time frame: 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.
Time frame: 3 years
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