Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538350
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Telemedicine in Palliative Care Interventions Experiences and Perceptions of Patients Diagnosed With Cancer
Sponsor:
None
Organization:
None
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:
No
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 11 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 11 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 11 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None