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CompletedNCT05620420Updated Nov 26, 2024

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

An observational study in Psychological Distress, Insomnia and Somatic Symptoms, sponsored by RenJi Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by RenJi Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
501
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psychological Distress
  • Insomnia
  • Somatic Symptoms

Keywords

  • multiple myeloma
  • mental health
03

In context

Sleep Initiation and Maintenance Disorders

2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.

This study's enrollment of 501 is above the median of 138 across 318 observational studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The patients will be recruited form 14 medical centers.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. has been signed.

Exclusion criteria

Exclusion Criteria:

  1. Who has kinship with other enrolled patients.
  2. of\< 6 months.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
501 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. morbidity of psychological distress in patients with multiple myeloma.

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

    Time frame: Baseline (the time when the patient is enrolled to the study)

Secondary outcomes

  1. morbidity of anxiety in patients with multiple myeloma.

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

    Time frame: Baseline (the time when the patient is enrolled to the study)

  2. morbidity of insomnia in patients with multiple myeloma.

    PSQI scale is applied to assess the insomnia of the patient

    Time frame: Baseline (the time when the patient is enrolled to the study)

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Study locations

1 site
  • shanghai Jiaotong University School of Medicine, Renji Hospital
    Shanghai, Shanghai, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05620420
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Nov 17, 2022
Start date
Nov 8, 2022
Primary completion
Nov 7, 2023
Completion
Nov 7, 2023
Last update
Nov 26, 2024

Study contacts

Jian Hou
principal investigator · RenJi Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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