Colorectal Cancer (MSI-H)NCT07059052
Illness Perception and Quality of Life in Colorectal Cancer With Ascites
An observational study of Colorectal Cancer (MSI-H), run by Hebei Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (MSI-H)
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Apr 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, 050000
About this study
Official title: Impact of Illness Perception on Quality of Life in Patients With Colorectal Cancer and 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.
Read the 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.
- Conditions
- Colorectal Cancer (MSI-H)
- Keywords
- Illness Perception, Colorectal Cancer with Ascites, Quality of Life, Age, Histological Grade
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed once per participant during the study period from January 2024 to April 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Jan 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (MSI-H)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 218 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hebei Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xujin Guo, Hebei Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059052
- Sponsor's protocol ID
- 2024021
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Illness Perception on Quality of Life in Patients With Colorectal Cancer and Ascites
- ClinicalTrials.gov ID
- NCT07059052
- Acronym / sponsor ID
- 2024021
- Conditions
- Colorectal Cancer (MSI-H)
- Keywords
- Illness Perception, Colorectal Cancer with Ascites, Quality of Life, Age, Histological Grade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Hebei Provincial Hospital of Traditional Chinese MedicineOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer (MSI-H), run by Hebei Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Score (time frame: Assessed once per participant during the study period from January 2024 to April 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.