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

NCT05620420 | Completed DMC

• 1 other identifier: LY2022-068-A
• Study Type: observational
• Target: 501
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Insomnia; Somatic Symptoms

Keywords

multiple myeloma; mental health

Outcome Measures

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.

  Baseline (the time when the patient is enrolled to the study)

Secondary Outcomes (2)

• morbidity of anxiety in patients with multiple myeloma.

  Baseline (the time when the patient is enrolled to the study)

• morbidity of insomnia in patients with multiple myeloma.

  Baseline (the time when the patient is enrolled to the study)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients will be recruited form 14 medical centers.

You may qualify if:

• Patients with symptomatic multiple myeloma were diagnosed according to the criteria of Chinese multiple myeloma diagnosis and treatment guidelines (revised in 2022).
• Age ≥18 years, with junior high school education or above. Patients have normal ability of communication and understanding.
• Informed consent has been signed.

You may not qualify if:

• Who has kinship with other enrolled patients.
• Life expectancy of\< 6 months.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Medically Unexplained Symptoms; Multiple Myeloma; Psychological Well-Being

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Personal Satisfaction; Behavior

Study Officials

• Jian Hou

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 17, 2022
• Study Start: November 8, 2022
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

CN (1)