Advanced CancerPALTELNCT06538350

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

A study testing Telemedicine Consultation and Face-to-Face Consultation in people with Advanced Cancer, run by OncoHelp Association.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Cancer
What is being tested?: Telemedicine Consultation and Face-to-Face Consultation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: No sites listed yet
Study dates: Oct 2024to Mar 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant Inclusion Criteria
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

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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
Participant has a high consumption of healthcare services
Participant has a reduced level of function
Participant is motivated to use telemedicine and will likely benefit from telemedicine solutions
Participant are willing to adhere to telemedicine consultations or face-to-face consultations
Caregiver Inclusion Criteria
Adult , age ≥ 18 years
Relative or friend who is identified by the Participant and lives with the Participant or has contact with him/her at least twice per week
The ability to read and respond to questions in Romanian language
Caregiver who is willing to participate in the study
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Have not themselves been diagnosed with cancer or received cancer treatment during the study (to ensure that the Participant and the caregiver focus their efforts on the care of the Participant)
Caregiver must have access to a computer/ tablet/ smartphone and an internet connection at home, on which they would be willing to do a telemedicine study
Be able to navigate websites, communicate by email, and have regular access to the internet (assessed by participant self-report)
Be capable of independently utilising an online platform for telemedicine medical consultations in a private setting (assessed by participant self-report)

Who cannot join

Participant Exclusion Criteria
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

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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
Caregiver Exclusion Criteria
Adult caregiver, age ≥ 18 years
Cognitive or psychiatric conditions as determined by the researcher investigator to prohibit study participation
Non-compliant caregiver with study procedures

Trial locations and contacts

No sites are listed yet.

Alexandra Kovacs, MD contact

0040742041811

aflavia.kovacs@gmail.com

About this study

Official title: Telemedicine in Palliative Care: Interventions, Experiences and Perceptions of Patients Diagnosed With Cancer Receiving Outpatient Palliative Care

Read the detailed description

This is a 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.

All trial activities will be conducted through the Outpatient Clinic of OncoHelp Association located in Timisoara, Romania.

Participants in this study will be recruited from newly diagnosed cancer patients who have not received palliative care interventions prior to enrollment. They are referred to the Outpatient Clinic of the OncoHelp Association for oncological and palliative registration, consultations, and treatment.

After gaining informed consent, a baseline assessment will be collected, including screening feasibility for the telemedicine arm. The selected patients will be randomly allocated with a 1:1 ratio to receive either:

Telemedicine consultation ( Intervention Arm) Group A Face-to-Face consultation ( Control Arm) Group B The participants will receive three monthly consultation and unscheduled consultations as they need according to the study arm they had been allocated.

The participants will benefit from the following categories of interventions depending on their needs :

Communication of diagnosis, prognosis, and treatment options
Mediation of patient-caregiver communication
Symptom control for pain, fatigue, nausea, depression, anxiety, drowsiness, comfort, dyspnoea, sweating, cough, constipation, haemorrhage, itching, secretions, dysphagia, appetite
Care of wounds, bedsores, stomas
End of life care
Patient and caregiver education
Psychological counseling
Reports for obtaining social rights (sickness pension, disability pension)
Reports for obtaining devices provided without personal contribution by the health insurance system
Referral for spiritual assistance
Management plan
Referral for specialized service level III
Referral for hospitalization
Unscheduled consultations

Conditions: Advanced Cancer
Being tested: Telemedicine Consultation, Face-to-Face Consultation
Keywords: Cancer, Palliative Care, Telemedicine, Outpatient
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telemedicine ConsultationOther
Telemedicine intervention will be delivered via Zoom and Video WhatsApp platforms via a secure internet connection.
Face-to-Face ConsultationOther
Face-to-Face consultation according to the standard of care.

Study groups in NCT06538350
Study group	Role	What they receive
Telemedicine consultations	Experimental	The experimental intervention will be delivered via Zoom and Video WhatsApp platforms via a secure internet connection. Receives: 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. Receives: Other: Face-to-Face Consultation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 12 weeks

Secondary outcomes (10)

eHealth Literacy .
Participants' ability to find and evaluate online health information will be measured using the eHealth Literacy Scale. The eHealth literacy scale is an eight-item scale used to asses self-reported capability of eHealth consumers to find, appraise, and use health related information from the internet to solve health problems . Scores are interpreted as follows: Predominantly Disagree: Scores range from 8 to 15.99; Mostly Disagree: Scores range from 16 to 23.99. Mostly Agree: Scores range from 24 to 31.99. Predominantly Agree: Scores range from 32 to 40.
Measured: Baseline and 12 weeks after baseline
Domain of intervention .
The interventions provided in this study will respect the principle of holistic care. Depending on the patient's needs, interventions will be provided in the physical, emotional, social, and spiritual domains during each scheduled or unscheduled visit.
During each visit, the interventions granted and the domains - physical, emotional, social and spiritual - to which these interventions belong will be recorded.
Measured: 12 weeks
Number of patients satisfied with physician communication .
14-item Communication Assessment Tool (CAT) will be used. The CAT specifically addresses patient satisfaction with key aspects of communication and interpersonal skills, and items are scored on a 1-5 scale where 1 = poor and 5 = excellent, and a higher score would indicate better communication skills.
Measured: 12 weeks
Patients' experiences .
Participants' experiences with the care will be measured using the Patient Reported Experience Measures Questionnaire (PREMs). Patients' experience is rated from poor (rated as 1) to excellent (rated as 5). Higher scores are related to higher satisfaction during consultation.
Measured: 12 weeks
Number of emergency room visit .
Monitoring patient interactions with the Emergency Room (ER) during the trial period.
Measured: 12 weeks
Number of unscheduled visits .
Monitoring the number of unscheduled visits.
Measured: 12 weeks
Adherence to intervention .
Intervention adherence will be estimated as the mean proportion of the scheduled consultations each participant completes .
Measured: 12 weeks
Changes in medication adherence .
Medication adherence will be measured using the Morisky Medication - Taking Adherence Scale (MMAS-4 Scale). The MMAS consists of four items, with a scoring scheme of "Yes" = 0 and "No" = 1. The items are summed to give a range of scores from 0 to 4 .
Measured: 12 weeks
Number of completed telemedicine scheduled visits .
Telemedicine will be feasible in this population if at least 80% complete the telemedicine visits. A visit will be considered successful if all measurements are recorded.
Measured: 12 weeks
Physicians ability to evaluate a patient through telemedicine .
Measured by the Provider Satisfaction with Telemedicine Questionnaire. This questionnaire will be completed by the interventionists after visit 3 . This survey included included 5 components: demographics, care settings, experience, motivation, and overall satisfaction.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2024Mar 2026

First posted5 Aug 2024
Study startOct 2024 (estimated)
Primary completionMar 2026 (estimated)
Study completionMar 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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
Masking: None (open label)
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06538350
Sponsor's protocol ID: Telemedicine. Palliative Care.
Acronym: PALTEL
Status last verified: Aug 2024
First submitted: 25 Jul 2024
Last updated: 6 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41550463

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telemedicine in Palliative Care: Interventions, Experiences and Perceptions of Patients Diagnosed With Cancer Receiving Outpatient Palliative Care
ClinicalTrials.gov ID: NCT06538350
Acronym / sponsor ID: PALTEL / Telemedicine. Palliative Care.
Conditions: Advanced Cancer
Keywords: Cancer, Palliative Care, Telemedicine, Outpatient
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 160 participants (estimated)
Lead sponsor: OncoHelp AssociationUniversity, hospital or other
Study start: Oct 2024 (estimated)
Primary completion: Mar 2026 (estimated)
Study completion: Mar 2026 (estimated)
First posted: 5 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

All trial activities will be conducted through the Outpatient Clinic of OncoHelp Association located in Timisoara, Romania.

The participants will benefit from the following categories of interventions depending on their needs :

Communication of diagnosis, prognosis, and treatment options
Mediation of patient-caregiver communication
Symptom control for pain, fatigue, nausea, depression, anxiety, drowsiness, comfort, dyspnoea, sweating, cough, constipation, haemorrhage, itching, secretions, dysphagia, appetite
Care of wounds, bedsores, stomas
End of life care
Patient and caregiver education
Psychological counseling
Reports for obtaining social rights (sickness pension, disability pension)
Reports for obtaining devices provided without personal contribution by the health insurance system
Referral for spiritual assistance
Management plan
Referral for specialized service level III
Referral for hospitalization
Unscheduled consultations

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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

Arm	Type	Receives
Telemedicine consultations	Experimental	Other: Telemedicine ConsultationThe experimental intervention will be delivered via Zoom and Video WhatsApp platforms via a secure internet connection.
Face-to-Face Consultations	Active comparator	Other: Face-to-Face ConsultationPatients randomised to the control arm will continue with face-to-face consultations according to the standard of care.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (30 listed)

Participant Inclusion Criteria
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 )

Key exclusion criteria (19 listed)

Participant Exclusion Criteria
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telemedicine ConsultationTelemedicine intervention will be delivered via Zoom and Video WhatsApp platforms via a secure internet connection.	Other	Telemedicine consultations
Face-to-Face ConsultationFace-to-Face consultation according to the standard of care.	Other	Face-to-Face Consultations

Primary outcome

Patients' Quality of Life .
Time frame: 12 weeks
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.
Changes in symptom control .
Time frame: 12 weeks
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.
Patients' satisfaction .
Time frame: 12 weeks
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.

10 secondary outcomes

eHealth Literacy .
Time frame: Baseline and 12 weeks after baseline
Domain of intervention .
Time frame: 12 weeks
Number of patients satisfied with physician communication .
Time frame: 12 weeks
Patients' experiences .
Time frame: 12 weeks
Number of emergency room visit .
Time frame: 12 weeks
Number of unscheduled visits .
Time frame: 12 weeks
Adherence to intervention .
Time frame: 12 weeks
Changes in medication adherence .
Time frame: 12 weeks
Number of completed telemedicine scheduled visits .
Time frame: 12 weeks
Physicians ability to evaluate a patient through telemedicine .
Time frame: 12 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
Derived from this study: PubMed 41550463Kovacs 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexandra Kovacs, MD contact

0040742041811

aflavia.kovacs@gmail.com

Alexandra Kovacs, MD study chair

OncoHelp Association

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine Consultation and Face-to-Face Consultation in people with Advanced Cancer, run by OncoHelp Association.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alexandra Kovacs, MD (0040742041811, aflavia.kovacs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients' Quality of Life . (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06538350, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.