NCT07059052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

July 1, 2025

Last Update Submit

July 1, 2025

Conditions

Keywords

Illness PerceptionColorectal Cancer with AscitesQuality of LifeAgeHistological Grade

Outcome Measures

Primary Outcomes (2)

  • Quality of Life Score

    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.

    Assessed once per participant during the study period from January 2024 to April 2025

  • Illness Perception Score

    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.

    Assessed once per participant during the study period from January 2024 to April 2025

Study Arms (1)

Patients with Colorectal Cancer and Ascites

A single cohort of 218 patients with a confirmed diagnosis of colorectal cancer and concomitant ascites. These patients were treated at the Hebei Provincial Hospital of Traditional Chinese Medicine between January 2024 and April 2025. Data on their clinical characteristics, illness perceptions, and quality of life were collected at a single point in time for this cross-sectional analysis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population included patients diagnosed with colorectal cancer and concomitant ascites. Participants were recruited from those treated at the Hebei Provincial Hospital of Traditional Chinese Medicine between January 2024 and April 2025. All consecutive patients who met the specific inclusion and exclusion criteria during this period and provided informed consent were enrolled in this cross-sectional study.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 1, 2025

First Posted

July 10, 2025

Study Start

January 1, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

July 10, 2025

Record last verified: 2025-07

Locations