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

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05620420
Collaborator
(none)
500
Enrollment
9
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Multicenter Cross-sectional Study on Mental Health of Patients With Multiple Myeloma
    Anticipated Study Start Date :
    Nov 15, 2022
    Anticipated Primary Completion Date :
    Aug 15, 2023
    Anticipated Study Completion Date :
    Aug 15, 2023

    Outcome Measures

    Primary Outcome Measures

    1. morbidity of psychological distress in patients with multiple myeloma. [Baseline (the time when the patient is enrolled to the study)]

      The total score of DT scale ≥4 points is defined as obviously psychological distress.

    Secondary Outcome Measures

    1. morbidity of anxiety in patients with multiple myeloma. [Baseline (the time when the patient is enrolled to the study)]

      GAD-7 scale is applied to assess the anxiety of the patient

    2. morbidity of insomnia in patients with multiple myeloma. [Baseline (the time when the patient is enrolled to the study)]

      PSQI scale is applied to assess the insomnia of the patient

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05620420
    Other Study ID Numbers:
    • LY2022-068-A
    First Posted:
    Nov 17, 2022
    Last Update Posted:
    Nov 17, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by RenJi Hospital
    multiple myeloma
    mental health
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Medically Unexplained Symptoms

    Study Results

    No Results Posted as of Nov 17, 2022