Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635694
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
naVIGation Invitations Liver surveillANce upTake
Sponsor:
None
Organization:
None
Study Overview
Official Title:
naVIGation Invitations Liver surveillANce upTake
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
VIGILANT
Brief Summary:
This study aims to evaluate the efficacy of Patient Navigators and mailed surveillance invitations on attendance of Hepatocellular Carcinoma HCC ultrasound surveillance appointments The investigators hypothesise that mailed invitations and Patient Navigators will improve attendance at HCC surveillance appointments and increase the proportion of patients diagnosed at an early stage compared with a control group receiving usual care
Detailed Description:
Hepatocellular carcinoma HCC is the third leading cause of cancer-related death worldwide Despite advances in treatment options prognosis remains worrying with 5-year survival rates remaining less than 20
Surveillance for HCC involves six-monthly ultrasounds US of the liver and has been demonstrated to increase rate of early diagnosis which translates to improved survival However the uptake of HCC surveillance is low internationally in Western countries only 20 of patients eligible for HCC surveillance receive a surveillance test
The current provision of HCC surveillance in the UK is ad hoc eligible patients have six-monthly ultrasound requested by their clinician usually a gastroenterologist hepatologist or hepatology clinical nurse specialist Patients receive an ultrasound appointment in the post with no formal invitation or information about the surveillance test Work with focus groups suggests lack of knowledge and fear are barriers to HCC surveillance attendance
Previous research has shown that patient navigation increased HCC surveillance uptake in an American population However there has been no research on interventions aimed at improving surveillance uptake in the UK population
The study predicts that the mailed invitations and Patient Navigators will improve patient attendance at HCC surveillance and increases the number of patients diagnosed with early-stage HCC compared with usual care
Surveillance for HCC involves six-monthly ultrasounds US of the liver and has been demonstrated to increase rate of early diagnosis which translates to improved survival However the uptake of HCC surveillance is low internationally in Western countries only 20 of patients eligible for HCC surveillance receive a surveillance test
The current provision of HCC surveillance in the UK is ad hoc eligible patients have six-monthly ultrasound requested by their clinician usually a gastroenterologist hepatologist or hepatology clinical nurse specialist Patients receive an ultrasound appointment in the post with no formal invitation or information about the surveillance test Work with focus groups suggests lack of knowledge and fear are barriers to HCC surveillance attendance
Previous research has shown that patient navigation increased HCC surveillance uptake in an American population However there has been no research on interventions aimed at improving surveillance uptake in the UK population
The study predicts that the mailed invitations and Patient Navigators will improve patient attendance at HCC surveillance and increases the number of patients diagnosed with early-stage HCC compared with usual care
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