Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT06538350
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06538350
Study Brief:
Protocol Section:
NCT06538350