Cognitive Dysfunction in Patients With Cancer Pain

Cognitive Dysfunction Clinical Trial

Official title:

Correlative Factors of Cognitive Dysfunction in Patients With Cancer Pain: a Cross-sectional Study From China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03641820
• Other study ID #: FJZL20180407
• Status: Recruiting
• Start date: August 21, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: August 2018
• Source: Fujian Cancer Hospital
• Contact: huiyu luo
• Phone: 13799365820
• Email: 13799365820[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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, prevention and treatment. In order to achieve the purpose of improving the quality of life of cancer patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 928
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Cancer Pain
• Cognitive Dysfunction

Locations

Country	Name	City	State
China	Department of Nursing, Fujian Provincial Cancer Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months