Cognitive DysfunctionNCT03641820
Cognitive Dysfunction in Patients With Cancer Pain
An observational study of Cognitive Dysfunction, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
To investigate the occurrence of cognitive dysfunction in cancer patients with pain in China.Analysis of patients with different cancer pain, different analgesic drugs and different treatments are associated with the severity of cognitive dysfunction, to provide relevant evidence for the next screening, prediction… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cognitive Dysfunction
- How many people
- 928 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2018to 28 Feb 2019
- How long will I take part?
- 6 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Malignant tumor patient with pain
Who may be able to join
- Malignant tumor patient with pain are confirmed by histopathology or cytology (NRS score ≥ 1);
- Understand Chinese through verbal and written communication, read and write Chinese, numbers, and complete questionnaire surveys;
- Male or female, age 18-75 years old;
- ECOG 0-2, expected to survive for more than 3 months;
- no obvious dysfunction of heart, lung, liver, kidney, blood system (≤I degree);
- patients voluntarily sign informed consent
Who cannot join
- Pregnant women and lactating women.
- Also participate in clinical trials of drugs that have not been approved for marketing.
- Patients with depression (evaluated by the Hamilton Depression Scale).
- Active bleeding or bleeding tendency.
- Serious or uncontrolled medical conditions and infected people.
- Patients with structural heart disease, such as coronary heart disease, unstable angina, especially patients with congestive heart failure and atrial fibrillation, atrial flutter history, and patients with hypertension, hypercoagulable state and severe cerebrovascular disease.
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- History of thromboembolic disease; long-term oral administration of aspirin and other anticoagulants.
- Preventive Whole Brain Irradiation (PCI).
- Bone marrow invasion or bone marrow metastasis.
- Patients with severe or uncontrollable mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nursing, Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014
huiyu luo, 13799365820, 13799365820@163.com
About this study
Official title: Correlative Factors of Cognitive Dysfunction in Patients With Cancer Pain: a Cross-sectional Study From China
To investigate the occurrence of cognitive dysfunction in cancer patients with pain in China.Analysis of patients with different cancer pain, different analgesic drugs and different treatments are associated with the severity of cognitive dysfunction, to provide relevant evidence for the next screening, prediction, prevention and treatment. In order to achieve the purpose of improving the quality of life of cancer patients.
Read the detailed description
Cross-sectional survey in patients with cancer pain is used in the outpatient clinics and wards of five cancer hospitals in China.
This study is to survey the incidence of cognitive dysfunction in Chinese cancer patients, and the related factors of cognitive dysfunction, demographic characteristics (economic situation, education, gender, age), disease status (tumor type, staging) ), analgesic treatment (NRS score, with or without analgesic drugs, analgesic drug name, dose), anti-tumor treatment (with or without anti-tumor treatment, surgery, radiotherapy, chemotherapy, time interval from last treatment, chemotherapy drugs) and so on.
- Conditions
- Cognitive Dysfunction
- Medical subject headings
- Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Cancer-related cognitive dysfunction patient with pain
Statistical analysis was performed SPSS 21.0. The t test was used for comparison between groups, and the X2 test was used for the count data. The logistic regression model was used for multivariate analysis. The regression coefficient, P value and OR value were calculated by age, ethnicity, education level, treatment plan and income as covariates.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start21 Aug 2018
- Primary completion28 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 928 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641820
- Sponsor's protocol ID
- FJZL20180407
- Status last verified
- Aug 2018
- First submitted
- 20 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlative Factors of Cognitive Dysfunction in Patients With Cancer Pain: a Cross-sectional Study From China
- ClinicalTrials.gov ID
- NCT03641820
- Acronym / sponsor ID
- FJZL20180407
- Conditions
- Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 928 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 22 Aug 2018 (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.
To investigate the occurrence of cognitive dysfunction in cancer patients with pain in China.Analysis of patients with different cancer pain, different analgesic drugs and different treatments are associated with the severity of cognitive dysfunction, to provide relevant evidence for the next screening, prediction, prevention and treatment. In order to achieve the purpose of improving the quality of life of cancer patients.
Detailed description
Cross-sectional survey in patients with cancer pain is used in the outpatient clinics and wards of five cancer hospitals in China.
This study is to survey the incidence of cognitive dysfunction in Chinese cancer patients, and the related factors of cognitive dysfunction, demographic characteristics (economic situation, education, gender, age), disease status (tumor type, staging) ), analgesic treatment (NRS score, with or without analgesic drugs, analgesic drug name, dose), anti-tumor treatment (with or without anti-tumor treatment, surgery, radiotherapy, chemotherapy, time interval from last treatment, chemotherapy drugs) and so on.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Malignant tumor patient with pain
Key inclusion criteria (6 listed)
- Malignant tumor patient with pain are confirmed by histopathology or cytology (NRS score ≥ 1);
- Understand Chinese through verbal and written communication, read and write Chinese, numbers, and complete questionnaire surveys;
- Male or female, age 18-75 years old;
- ECOG 0-2, expected to survive for more than 3 months;
- no obvious dysfunction of heart, lung, liver, kidney, blood system (≤I degree);
Key exclusion criteria (10 listed)
- Pregnant women and lactating women.
- Also participate in clinical trials of drugs that have not been approved for marketing.
- Patients with depression (evaluated by the Hamilton Depression Scale).
- Active bleeding or bleeding tendency.
- Serious or uncontrolled medical conditions and infected people.
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
Prevalence of Cancer-related cognitive dysfunction patient with pain
Time frame: 6 months
Statistical analysis was performed SPSS 21.0. The t test was used for comparison between groups, and the X2 test was used for the count data. The logistic regression model was used for multivariate analysis. The regression coefficient, P value and OR value were calculated by age, ethnicity, education level, treatment plan and income as covariates.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 Cognitive Dysfunction, run by Fujian Cancer Hospital 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact huiyu luo (13799365820, 13799365820@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Cancer-related cognitive dysfunction patient with pain (time frame: 6 months). 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 22 Aug 2018; AzTrials last refreshed its copy on 31 Oct 2026.