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

NCT06461780 | Recruiting

• 4 other identifiers: 2023-03-005BCNSTC 114-2314-B-A49 -008 -NSTC 113-2314-B-A49 -013 -NSTC 112-2314-B-A49 -077 -
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Immunotherapy; IrAE; Distress, Emotional; Care Need; Financial Toxicity; Quality of Life

Outcome Measures

Primary Outcomes (7)

• 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)

Study Arms (2)

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.

Interventions

Line-based questionnaire follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Yang Ming Chiao Tung University: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms; Financial Stress

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• I-Wen Chang, PHD

  Taipei Veterans General Hospital, Taiwan

  STUDY CHAIR

Central Study Contacts

I-Wen Chang, PHD

CONTACT

886-2-2875-7193; iwchang@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: March 18, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)