Cognitive Dysfunction in Patients With Cancer Pain

August 21, 2018 updated by: Fujian Cancer Hospital

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

928

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Department of Nursing, Fujian Provincial Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Malignant tumor patient with pain

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2018

Primary Completion (Anticipated)

February 28, 2019

Study Completion (Anticipated)

February 28, 2019

Study Registration Dates

First Submitted

August 20, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJZL20180407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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