Clinical trial NCT03641820: Cognitive Dysfunction in Patients With Cancer Pain
Official title: Correlative Factors of Cognitive Dysfunction in Patients With Cancer Pain: a Cross-sectional Study From China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Dysfunction
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2018-08-22
Enrollment: 928
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Malignant tumor patient with pain

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Cancer-related cognitive dysfunction patient with pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nursing, Fujian Provincial Cancer Hospital
state: Fujian
Study officials:
References: