Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
Study NCT ID:
NCT06538350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-06
First Post:
2024-07-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telemedicine in Palliative Care: Interventions, Experiences and Perceptions of Patients Diagnosed With Cancer
Sponsor:
OncoHelp Association
Organization:
Study Overview
Official Title:
Telemedicine in Palliative Care: Interventions, Experiences and Perceptions of Patients Diagnosed With Cancer Receiving Outpatient Palliative Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PALTEL
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: