Clinical trial NCT06538350: Telemedicine in Palliative Care: Interventions, Experiences and Perceptions of Patients Diagnosed With Cancer
Official title: Telemedicine in Palliative Care: Interventions, Experiences and Perceptions of Patients Diagnosed With Cancer Receiving Outpatient Palliative Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Cancer
Keywords: Cancer
Palliative Care
Telemedicine
Outpatient
Lead sponsor: OncoHelp Association
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: OTHER

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.

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 :

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

Eligibility criteria: Inclusion Criteria:

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
* 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)

Exclusion Criteria:

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
* 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

Primary outcomes:
measure: Patients' Quality of Life .
timeFrame: 12 weeks
measure: Changes in symptom control .
timeFrame: 12 weeks
measure: Patients' satisfaction .
timeFrame: 12 weeks
Secondary outcomes:
measure: eHealth Literacy .
timeFrame: Baseline and 12 weeks after baseline
measure: Domain of intervention .
timeFrame: 12 weeks
measure: Number of patients satisfied with physician communication .
timeFrame: 12 weeks
measure: Patients' experiences .
timeFrame: 12 weeks
measure: Number of emergency room visit .
timeFrame: 12 weeks
measure: Number of unscheduled visits .
timeFrame: 12 weeks
measure: Adherence to intervention .
timeFrame: 12 weeks
measure: Changes in medication adherence .
timeFrame: 12 weeks
measure: Number of completed telemedicine scheduled visits .
timeFrame: 12 weeks
measure: Physicians ability to evaluate a patient through telemedicine .
timeFrame: 12 weeks
Other outcomes:
measure: Proportion of participants enrolled
timeFrame: Baseline
measure: Number of participants ineligible or refusing to participate .
timeFrame: Baseline
measure: Frequency of participant ineligibility reason
timeFrame: Baseline
measure: Frequency of participant refusal reason
timeFrame: Baseline
measure: Retention rate
timeFrame: 12 weeks
measure: Completion rate
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: OncoHelp Association
name: Alexandra Kovacs, MD
role: STUDY_CHAIR
References: