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

Taipei Veterans General Hospital

Status: Enrolling

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

Treatments: Other: Line-based questionnaire follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT06461780

2023-03-005BC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

Other: Line-based questionnaire follow-up