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

NCT ID: NCT06461780

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2028-08-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Intervention

The Line-based questionnaire follow-up app will be used to collect and follow patients' condition and syndrome.

Group Type: EXPERIMENTAL

Line-based questionnaire follow-up

Intervention Type: OTHER

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.

Interventions

Line-based questionnaire follow-up

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

I-Wen Chang, PHD

Role: STUDY_CHAIR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

I-Wen Chang, PHD

Role: CONTACT

iwchang@vghtpe.gov.tw

886-2-2875-7193

Facility Contacts

I-Wen Chang, PHD

Role: primary

iwchang@vghtpe.gov.tw

886-2-2875-7193

Other Identifiers

2023-03-005BC

Identifier Type: -

Identifier Source: org_study_id