Telemedicine in Palliative Care: Interventions, Experiences and Perceptions of Patients Diagnosed With Cancer

NCT06538350 | Not Yet Recruiting

• 1 other identifier: Telemedicine. Palliative Care.
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to estimate the effects of a palliative care consultation intervention among adults with advanced cancer delivered either as a remote (telemedicine) or face-to-face consultation, on changing symptom scores, quality of life, communication, participants' experiences, e-health literacy, emergency and unscheduled visits, adherence to treatment, retention rate, adherence rate, the level of satisfaction of patients and healthcare professionals.

Conditions

Advanced Cancer

Keywords

Cancer; Palliative Care; Telemedicine; Outpatient

Outcome Measures

Primary Outcomes (3)

• Patients' Quality of Life .

  To determine whether telemedicine palliative care consultations are equivalent to face-to-face palliative care consultations for improving patients' quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC-QLQ-C30). All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. Patients' Quality of Life \[ Time Frame:12 weeks\] To determine whether telemedicine consultations palliative care is are equivalent to face-to-face palliative care consultations for improving patients' quality of life as measured by the EORTC-QLQ-C30 Questionnaire.

  12 weeks

• Changes in symptom control .

  Symptom management will be measured through the mean changes in distress score on the Integrated Palliative care Outcome Scale (IPOS). There are 10 questions scored on a scale of 1-4, which assess a patient's symptoms and needs with regards to physical, social, psychological and spiritual. Individual IPOS item scores of zero or one require less clinical attention than items that score three or four.

  12 weeks

• Patients' satisfaction .

  To assess the effect of the superiority of telemedicine versus face-to-face consultations about palliative care on patient satisfaction as measured by the 16-item measure of Patient Satisfaction Questionnaire(FAMCARE P 16 Questionnaire). This is a self-report scale assessing patient satisfaction with outpatient palliative oncology care, which is composed of 16 items rated from 1 (very dissatisfied) to 5 (very satisfied). Higher scores are related to higher satisfaction with the care received.

  12 weeks

Secondary Outcomes (10)

• eHealth Literacy .

  Baseline and 12 weeks after baseline

• Domain of intervention .

  12 weeks

• Number of patients satisfied with physician communication .

  12 weeks

• Patients' experiences .

  12 weeks

• Number of emergency room visit .

  12 weeks

Other Outcomes (6)

• Proportion of participants enrolled

  Baseline

• Number of participants ineligible or refusing to participate .

  Baseline

• Frequency of participant ineligibility reason

  Baseline

Study Arms (2)

Telemedicine consultations

EXPERIMENTAL

The experimental intervention will be delivered via Zoom and Video WhatsApp platforms via a secure internet connection.

Other: Telemedicine Consultation

Face-to-Face Consultations

ACTIVE COMPARATOR

Patients randomised to the control arm will continue with face-to-face consultations according to the standard of care.

Other: Face-to-Face Consultation

Interventions

Telemedicine Consultation OTHER

Telemedicine intervention will be delivered via Zoom and Video WhatsApp platforms via a secure internet connection.

Telemedicine consultations

Face-to-Face Consultation OTHER

Face-to-Face consultation according to the standard of care.

Face-to-Face Consultations

Eligibility Criteria

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

You may qualify if:

• Adult patients, age ≥ 18 years
• Diagnosis of solid tumour in any stage, regardless of location
• Participant diagnosed within the last 90 days with advanced or metastatic cancer (defined as a newly diagnosed stage II-IV, recurrence, or progressive solid tumour cancer)
• Eastern Cooperative Oncology Group (ECOG ) 1 ( ambulatory ) - 3 ( symptomatic, bed immobilised\> 50% during the day )
• Estimated life expectancy of at least three months
• Participants can receive any cancer treatment for their advanced cancer while participating in this study
• Receiving primary cancer care at the participating site
• Have access to a telephone that can receive incoming calls
• Participant/ caregiver can use a personal computer, smartphone, tablet
• Participants must have access to a Wi-Fi network or a cellular network
• Participant can communicate verbally
• Participant can read and respond to questions in the Romanian language
• Participant able to provide informed consent
• Participant has a considerable disease burden and complex medical and care needs
• Participant is at a medium to high risk of worsening their condition, requiring hospitalisation, or having an increased need for health and care services

You may not qualify if:

• Participant already receiving outpatient palliative care or hospice services
• Participant with Eastern Cooperative Oncology Group (ECOG) 4 performance status
• Participant too medically unstable (or expected to become so during the study period) to participate in a telemedicine group medical visit determined by the investigator
• Participants with a high level of distress who cannot be managed by telemedicine
• End of Life
• Participant with extensive hearing loss such that the ability to participate in the study would be impaired as determined by the investigator
• Self-reported history of a diagnosis of dementia
• Self-reported psychotic symptoms in the last 30 days prior to randomisation
• Active suicidal ideation (currently reported suicidal plan and intent)
• Self-reported active alcohol or substance abuse in the last 30 days prior to randomisation
• Any change in psychotropic medications within the last 30 days
• Participant without medical insurance that covers telemedicine consultations or face-to-face consultations
• Participant who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
• Failure/inability/unwillingness to provide names and contact information for two family members or friends to serve as emergency contacts during the study
• Adult caregiver, age ≥ 18 years

Sponsors & Collaborators

• OncoHelp Association: lead

Related Publications (1)

• Kovacs A, Payne S, Mosoiu D. Efficacy of telemedicine for cancer patients in outpatient palliative care setting: Protocol of a randomized, open-label, non-inferiority study. Palliat Care Soc Pract. 2026 Jan 13;20:26323524251408888. doi: 10.1177/26323524251408888. eCollection 2026.

  PMID: 41550463 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Alexandra Kovacs, MD

  OncoHelp Association

  STUDY CHAIR

Central Study Contacts

Alexandra Kovacs, MD

CONTACT

0040742041811; aflavia.kovacs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, single-centre, randomized, with parallel assignment, controlled trial, with a 1:1 allocation across two treatment arms: telemedicine consultations versus face-to-face consultations

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 5, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share