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Trial Title:
Exploring Physical and Psychological Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy
NCT ID:
NCT06461780
Condition:
Cancer
Immunotherapy
IrAE
Distress, Emotional
Care Need
Financial Toxicity
Quality of Life
Conditions: Official terms:
Financial Stress
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Line-based questionnaire follow-up
Description:
The participant will use LINE group to report irAE severity, distress, financial toxicity
and change trajectory of quality of life in one-year follow-up. If the severity grade of
irAE reach the threshold and require referral, an alarm will appear to notify the
research team to conduct and transfer to a clinical specialitst, or refer to the
emergency room for treatment. Additionally, the Line group will also provide clinical
relevant immunotherapy health education information currently and routinely used in study
site. Patients can view it according to their interests, but the APP will not actively
promote it.
Arm group label:
Intervention
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- (1) Patients diagnose cancer and are informed
- (2) Aged ≥18 years old
- (3) Conscious clear and able to communicate
Exclusion Criteria:
- (1) Patients who are under other clinical trial
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
I-Wen Chang, PHD
Phone:
886-2-2875-7193
Email:
iwchang@vghtpe.gov.tw
Start date:
August 1, 2024
Completion date:
August 1, 2028
Lead sponsor:
Agency:
Taipei Veterans General Hospital, Taiwan
Agency class:
Other
Collaborator:
Agency:
National Yang Ming Chiao Tung University
Agency class:
Other
Source:
Taipei Veterans General Hospital, Taiwan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06461780
