Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05500391
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2022-08-10
Brief Title:
Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
Study Overview
Official Title:
Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring
Status:
RECRUITING
Status Verified Date:
2024-03
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:
SUR-CAN
Brief Summary:
This is a multicenter interventional randomized study among adult patients recently diagnosed with a rare tumor 12 months The study will aim to compare compliance with the personalized post-treatment surveillance plan established for each patient according to national guidelines when the surveillance is conducted in person by a hospital-based physician control arm or remotely by a trained nurse experimental arm
Detailed Description:
The primary objective of this study is to compare 2-year compliance with the personalized post-treatment surveillance plan between the two arms
The secondary objectives are to compare between the two arms
Long-term compliance 5-year follow-up
Use of care
Oncological events and their management
Supportive care needs
The exploratory objectives are to
Evaluate the costs in terms of medical transportation
Evaluate and compare patients satisfaction and psychological well-being in terms of anxietydepression
Evaluate the homogeneity of the impact of the intervention according to covariates gender tumor pathology occupational status and center
Evaluate the reasons for recruitment failures
The secondary objectives are to compare between the two arms
Long-term compliance 5-year follow-up
Use of care
Oncological events and their management
Supportive care needs
The exploratory objectives are to
Evaluate the costs in terms of medical transportation
Evaluate and compare patients satisfaction and psychological well-being in terms of anxietydepression
Evaluate the homogeneity of the impact of the intervention according to covariates gender tumor pathology occupational status and center
Evaluate the reasons for recruitment failures
Study Oversight
Has Oversight DMC:
None
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?:
None