Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461780
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-11
Brief Title:
Exploring Physical and Psychological Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
Exploring Physical and Psychological Distress Financial Toxicity Care Needs and Quality of Life in Patients Receiving Immunotherapy in One Year Follow-up
Status:
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:
None
Brief Summary:
During the immune checkpoint inhibitor therapy ICIT most of the patients stay at home but there is lacking of the studies to explore their physical and psychological distress financial toxicity care needs and quality of life Therefore the aims of this program are to 1 explore the immune-related adverse event irAE severity distress financial toxicity and quality of life and examine the psychometric testing of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator FACT-ICM 2 establish the LINE group for assessing irAE severity and change trajectory of quality of life in one-year follow-up and 3 combined retrospective chart review and the finding in aim 2 to develop the risk prediction model in order to identify the high risk population
Detailed Description:
To achieve aim 1 a cross-sectional design is conducted to explore irAE severity distress financial distress and quality of life in mixed type of cancer patients receiving ICIT A structural questionnaire will be used including Common Terminology Criteria for adverse events CTCAE 33 items Distress Thermometer DT the Comprehensive Score for financial Toxicity COST FACT-ICM and EORTC-QLQ C30 Correlation analysis and exploratory factor analysis will be used to examine the psychometric testing of FACT-ICM
To achieve aim 2 and 3 a prospective cohort study will be conducted to recruit 200 patients in first course receiving ICIT and follow for 1 year using LINE to report symptoms in weekly reporting within 3 months and once in 3-4 weeks in 4th -12th months during treatment Data will be collected at five times Before treatment for baseline the 3th 6th 9th 12th months using a set of questionnaires including CTCAE 33 items DT COST Supportive Care Needs Scale-short form34 and FACT-ICM
To achieve aim 2 and 3 a prospective cohort study will be conducted to recruit 200 patients in first course receiving ICIT and follow for 1 year using LINE to report symptoms in weekly reporting within 3 months and once in 3-4 weeks in 4th -12th months during treatment Data will be collected at five times Before treatment for baseline the 3th 6th 9th 12th months using a set of questionnaires including CTCAE 33 items DT COST Supportive Care Needs Scale-short form34 and FACT-ICM
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