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NCT05620420 Clinical Trial

A Multicenter Cross-sectional Study on Mental Health of Patients With Multiple Myeloma

Insomnia Clinical Trial

Official title:
A Multicenter Cross-sectional Study on Mental Health of Patients With Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05620420
Other study ID # LY2022-068-A
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 15, 2022
Est. completion date August 15, 2023

Study information
Verified date March 2023
Source RenJi Hospital
Contact Jia Liu
Phone +86-18918186325
Email liujia1798@renji.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multiple myeloma patients with normal ability of communication and understanding will be enrolled. DT, GAD-7, PHQ-15 and PSQI scales are designed to assess the mental health status of the patients. Demographic and disease data of patients will be collected as well. The main aim is to explore the factors affecting the mental health of myeloma patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date August 15, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients with symptomatic multiple myeloma were diagnosed according to the criteria of Chinese multiple myeloma diagnosis and treatment guidelines (revised in 2022). 2. Age =18 years, with junior high school education or above. Patients have normal ability of communication and understanding. 3. Informed consent has been signed. Exclusion Criteria: 1. Who has kinship with other enrolled patients. 2. Life expectancy of< 6 months.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China shanghai Jiaotong University School of Medicine, Renji Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary morbidity of psychological distress in patients with multiple myeloma. The total score of DT scale =4 points is defined as obviously psychological distress. Baseline (the time when the patient is enrolled to the study)
Secondary morbidity of anxiety in patients with multiple myeloma. GAD-7 scale is applied to assess the anxiety of the patient Baseline (the time when the patient is enrolled to the study)
Secondary morbidity of insomnia in patients with multiple myeloma. PSQI scale is applied to assess the insomnia of the patient Baseline (the time when the patient is enrolled to the study)
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