Psychological DistressNCT05620420
A Multicenter Cross-sectional Study on Mental Health of Patients With Multiple Myeloma
An observational study of Psychological Distress and Insomnia, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Insomnia, Somatic Symptoms
- How many people
- 501 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2022to 7 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients will be recruited form 14 medical centers.
Who may be able to join
- 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.
Who cannot join
- Who has kinship with other enrolled patients.
- Life expectancy of< 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site
shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality
About this study
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
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Medically Unexplained Symptoms, Multiple Myeloma, Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity of psychological distress in patients with multiple myeloma.
The total score of DT scale ≥4 points is defined as obviously psychological distress.
Measured: Baseline (the time when the patient is enrolled to the study)
Secondary outcomes (2)
morbidity of anxiety in patients with multiple myeloma.
GAD-7 scale is applied to assess the anxiety of the patient
Measured: Baseline (the time when the patient is enrolled to the study)
morbidity of insomnia in patients with multiple myeloma.
PSQI scale is applied to assess the insomnia of the patient
Measured: Baseline (the time when the patient is enrolled to the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start8 Nov 2022
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Hou, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620420
- Sponsor's protocol ID
- LY2022-068-A
- Status last verified
- Nov 2024
- First submitted
- 10 Nov 2022
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Cross-sectional Study on Mental Health of Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05620420
- Acronym / sponsor ID
- LY2022-068-A
- Conditions
- Psychological Distress, Insomnia, Somatic Symptoms
- Keywords
- multiple myeloma, mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be recruited form 14 medical centers.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Who has kinship with other enrolled patients.
- Life expectancy of< 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
morbidity of psychological distress in patients with multiple myeloma.
Time frame: 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.
2 secondary outcomes
morbidity of anxiety in patients with multiple myeloma.
Time frame: Baseline (the time when the patient is enrolled to the study)
morbidity of insomnia in patients with multiple myeloma.
Time frame: Baseline (the time when the patient is enrolled to the study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Hou principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Distress and Insomnia, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity of psychological distress in patients with multiple myeloma. (time frame: Baseline (the time when the patient is enrolled to the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.