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Completed

NCT Number: NCT07059052

Illness Perception and Quality of Life in Colorectal Cancer With Ascites

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Quality of Life Score

    Time frame: 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.

  2. Illness Perception Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hebei Provincial Hospital of Traditional Chinese Medicine

Other Gov

Registry information

Official study title

Impact of Illness Perception on Quality of Life in Patients With Colorectal Cancer and Ascites

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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