Exploring Physical and Psychological Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Cancer; Immunotherapy; Distress, Emotional; Financial Toxicity; IrAE; Care Need
• Intervention / Treatment: Other: Line-based questionnaire follow-up

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.

• Study Type: Observational
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: I-Wen Chang, PHD; Phone Number: 886-2-2875-7193; Email: iwchang@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: I-Wen Chang, PHD; Phone Number: 886-2-2875-7193; Email: iwchang@vghtpe.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited at inpatients and outpatient clinic of department of chest medicine, department of oncology, division of gastroenterology and hepatology, and department of obsterics and gynecology.

Description

Inclusion Criteria:

• (1) Patients diagnose cancer and are informed
• (2) Aged ≥18 years old
• (3) Conscious clear and able to communicate

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Aim 1: Cross-sectional study; 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.
Aim 2 and 3: Longitudinal follow-up; The Line-based questionnaire follow-up app will be used to collect and follow patients' condition and syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Report Outcome-- Common Terminology Criteria for adverse events (PRO-CTCAE)	Interviewers graded the severity of adverse events according to the Common Terminology Criteria for adverse events (CTCAE), version 5, from the National Cancer Institute (NCI). In this study, we included 33 important symptoms from PRO-CTCAE in immunotherapy patients.	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)	The Symptom Severity Scale (SSS) was used to evaluate the symptom severity of cancer patients. It included 25 common symptoms in cancer patients.The severity was scored by an 11-point numerical rating scale, from 0 (not at all) to 10 (very severe).	The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
Distress Thermometer (DT)	The Distress Theremometer is utilized to assess patients' emotional distress and its sources. The assessment was developed by National Comprehensive Cancer Network (NCCN) and to evaluate the psychological distress level of cancer patients. It a single-item-11-point scale, from 0 to 10 points, which ask patients about their overall distress level over the past week, with higher scores indicating higher levels of distress.	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)	The COST-FACIT developed by Souza, is used to assess patients' financial distress. It evaluates the financial situation of patients undergoing treatment for chronic diseases. The scale consists of 12 items rated on a 0 to 4 Likert-type scale, where 0 indicates "not at all important" and 4 indicates "very important." Lower scores indicate greater financial toxicity.	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)	The FACT-ICM is used to assess the quality of life in cancer patients undergoing immunotherapy. It comprises 25 symptom-related items specific to immune checkpoint modulation therapy and 27 items from the Functional Assessment of Cancer Therapy-General (FACT-G), totaling 52 items. Ratings are done on a 0 to 4 Likert-type scale, where 0 indicates no distress at all and 4 indicates extreme distress.	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)	To assess the convergent validity of the FACT-ICM, we employed this scale to analyze the correlation between two sets of quality of life data. It consists of 30 items assessing five major functional domains in cancer patients. Ratings for most items are done on a 1 to 4 Likert-type scale, where 1 indicates no presence and 4 indicates very severe presence of symptoms, with higher scores indicating poorer quality of life.	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)	The SCNS-SF34 comprises 34 items and utilizes a 1 to 5 Likert-type scoring system, where 1 indicates no need and 5 indicates the greatest need for assistance. Scores for each domain, based on the total scores of individual items, are standardized to a range of 0 to 100, with higher scores indicating greater unmet needs in that domain.	The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: National Yang Ming Chiao Tung University
• Investigators: Study Chair: I-Wen Chang, PHD, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Behavior; Financial Stress; Neoplasms
• Other Study ID Numbers: 2023-03-005BC; NSTC 114-2314-B-A49 -008 - (Other Grant/Funding Number: National Science and Technology Council); NSTC 113-2314-B-A49 -013 - (Other Grant/Funding Number: National Science and Technology Council); NSTC 112-2314-B-A49 -077 - (Other Grant/Funding Number: National Science and Technology Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Based on the Institutional Review Board of the study site, the patients does not agree to give their data to other study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No