Exploring Physical and Psychological Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer, Immunotherapy, IrAE, Distress, Emotional. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exploring Physical and Psychological Distress, Financial Toxicity, Care Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy in One Year Follow-up: Psychometric Testing and Developing Prediction Models for Immune-related Adverse Events
Overview
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.
Primary outcome measures
- Patient-Report Outcome-- Common Terminology Criteria for adverse events (PRO-CTCAE) [Time frame: The data will be collected once a week within 3 months and once in 3-4 weeks in 4th-12th months during treatment.]
- Symptom Severity Scale (SSS) [Time frame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)]
- Distress Thermometer (DT) [Time frame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)]
- The COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) [Time frame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)]
- The Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM) [Time frame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)]
- European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30) [Time frame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)]
- Supportive Care Needs Survey-Short Form 34 (SCNS-SF34) [Time frame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)]
Eligibility criteria
Inclusion criteria
- (1) Patients diagnose cancer and are informed
- (2) Aged ≥18 years old
- (3) Conscious clear and able to communicate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- Taipei Veterans General Hospital — Taipei
Identifiers
NCT: NCT06461780 · 2023-03-005BC · NSTC 114-2314-B-A49 -008 - · NSTC 113-2314-B-A49 -013 - · NSTC 112-2314-B-A49 -077 -