Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452446
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Brief Title:
Telehealth-based Symptom Management for Veterans Treated With Selinexor
Sponsor:
Durham VA Medical Center
Organization:
Durham VA Medical Center
Study Overview
Official Title:
Telehealth-based Symptom Management for Veterans Treated With Selinexor
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Selinexor
Brief Summary:
The purpose of this study is to find out if continued monitoring of side effects from Selinexor and prescribed medication to prevent side effects helps improve symptoms quality of life and ability to continue the treatment longer
Detailed Description:
The primary objective of this study is to evaluate control of treatment-related and cancer-associated symptoms over the first three months of therapy with selinexor in Veterans who participate in a telehealth symptom management intervention
The secondary objectives are
To describe characteristics of patients treated with selinexor
To describe adherence with the telehealth intervention
To define the type and frequency of adverse events that patients experience while taking selinexor
To describe the duration of selinexor therapy and evaluate adherence and dose intensity of selinexor in VA cancer patients receiving a telehealth symptom management intervention
To describe concomitant medication usage in patients treated with selinexor
To assess quality of life in patients treated with selinexor in the VA
To estimate progression-free survival in VA cancer patients treated with selinexor
The secondary objectives are
To describe characteristics of patients treated with selinexor
To describe adherence with the telehealth intervention
To define the type and frequency of adverse events that patients experience while taking selinexor
To describe the duration of selinexor therapy and evaluate adherence and dose intensity of selinexor in VA cancer patients receiving a telehealth symptom management intervention
To describe concomitant medication usage in patients treated with selinexor
To assess quality of life in patients treated with selinexor in the VA
To estimate progression-free survival in VA cancer patients treated with selinexor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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