Clinical trial NCT06461780: Exploring Physical and Psychological Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy
Official title: Exploring Physical and Psychological Distress, Financial Toxicity, Care Needs and Quality of Life in Patients Receiving Immunotherapy in One Year Follow-up
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Immunotherapy
IrAE
Distress, Emotional
Care Need
Financial Toxicity
Quality of Life
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2024-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Patient-Report Outcome-- Common Terminology Criteria for adverse events (PRO-CTCAE)
timeFrame: The data will be collected once a week within 3 months and once in 3-4 weeks in 4th-12th months during treatment.
measure: Symptom Severity Scale (SSS)
timeFrame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
measure: Distress Thermometer (DT)
timeFrame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
measure: The COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT)
timeFrame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
measure: The Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM)
timeFrame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
measure: European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)
timeFrame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
measure: Supportive Care Needs Survey-Short Form 34 (SCNS-SF34)
timeFrame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: I-Wen Chang, PHD
role: STUDY_CHAIR
References: