Illness Perception and Quality of Life in Colorectal Cancer With Ascites

Completed

• Conditions: Colorectal Cancer (MSI-H)

• Registration Number: NCT07059052
• Lead Sponsor: Hebei Provincial Hospital of Traditional Chinese Medicine

Brief Summary

This study aimed to investigate the impact of illness perception on the quality of life (QoL) in patients diagnosed with colorectal cancer (CRC) complicated by ascites. The study explores how patients' cognitive and emotional beliefs about their illness relate to their physical, psychological, and social well-being.

Detailed Description

Colorectal cancer (CRC) is a leading cause of cancer-related mortality worldwide, and many patients are diagnosed at advanced stages with complications such as malignant ascites, which severely impairs quality of life (QoL). Illness perception, the framework of beliefs a patient develops about their illness, is known to influence health outcomes. However, this relationship is not well-studied in the specific subgroup of CRC patients with ascites.

This cross-sectional, observational study was designed to fill this gap. A total of 218 patients with CRC and ascites were enrolled. The study collected clinical and demographic data, and assessed illness perception using the Brief Illness Perception Questionnaire (BIPQ) and QoL using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The primary goal was to analyze the correlation between dimensions of illness perception and domains of QoL, and to identify independent clinical and demographic factors that predict patient QoL. The findings are intended to inform the development of targeted psychosocial interventions to improve patient well-being in this vulnerable population.

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

• Confirmed diagnosis of colorectal cancer with ascites, verified by imaging and pathological examination.
• Patient and/or legal guardian provided informed consent.
• Karnofsky Performance Status (KPS) score ≥50.
• Estimated survival ≥6 months.

Exclusion Criteria

• Presence of other active malignant tumors.
• Severe physical disability precluding participation.
• Severe cardiac, hepatic, or renal dysfunction not related to CRC.
• Presence of severe psychiatric or cognitive disorders.
• History of alcohol or drug addiction.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life Score	Assessed once per participant during the study period from January 2024 to April 2025	Assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0). This 30-item questionnaire evaluates global health status, five functional scales (physical, role, emotional, cognitive, social), and symptom scales. All scores are transformed to a 0-100 scale. For functional scales and global QoL, higher scores represent better functioning or QoL.
Illness Perception Score	Assessed once per participant during the study period from January 2024 to April 2025	Assessed using the Brief Illness Perception Questionnaire (BIPQ). This 8-item questionnaire evaluates cognitive and emotional representations of illness on a 0-10 scale. The total score ranges from 0 to 80, with higher scores indicating a more threatening or negative illness perception after reverse-scoring relevant items.

Trial Locations

Locations (1)

Hebei Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Shijiazhuang, Hebei, China