NCT03641820

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
928

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 21, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

August 20, 2018

Last Update Submit

August 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Malignant tumor patient with pain

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing, Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 22, 2018

Study Start

August 21, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

August 22, 2018

Record last verified: 2018-08

Locations