An observational study in Hematologic Disease, sponsored by The First Affiliated Hospital of Xiamen University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by The First Affiliated Hospital of Xiamen University · Observational
Assessment of Anxiety and Depression Status in Patients with Hematologic Malignancies
This is a single-center, prospective, observational cohort study designed to evaluate the association between anxiety and depression and treatment outcomes in patients newly diagnosed with lymphoma or multiple myeloma.
Approximately 100 patients will be enrolled. Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) before treatment and at 3, 6, and 12 months after treatment initiation. Patients will receive standard anticancer treatment without study-related modifications and will be followed for at least 24 months.
The primary objective is to investigate the association between anxiety and/or depression and treatment failure within 24 months. Secondary objectives include evaluating associations with progression-free survival, overall survival, treatment response, and treatment tolerability.
476 studies on the registry are indexed under Hematologic Diseases; 109 are open to participants now.
This study's planned enrollment of 100 is below the median of 237 across 134 observational studies indexed under Hematologic Diseases.
Browse Hematologic Diseases studies →The First Affiliated Hospital of Xiamen University is the lead sponsor of 118 studies on the registry; 79 are open to participants now.
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Patients meeting the inclusion and exclusion criteria will be enrolled. Baseline characteristics, medical history, treatment information, clinical assessments, and study-specific laboratory data before and after treatment will be collected. Patients will be followed longitudinally to evaluate disease response, remission, and progression.
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Exclusion Criteria:
1. Patients with any other conditions considered by the investigator to be inappropriate for participation in this study.
Patients with newly diagnosed lymphoma or multiple myeloma who have a baseline Hospital Anxiety and Depression Scale-Anxiety (HADS-A) score of 8 or higher and/or a Hospital Anxiety and Depression Scale-Depression (HADS-D) score of 8 or higher. All patients receive standard anticancer treatment according to routine clinical practice.
Other: Baseline Anxiety and/or Depression
Patients with newly diagnosed lymphoma or multiple myeloma who have baseline HADS-A and HADS-D scores both below 8. All patients receive standard anticancer treatment according to routine clinical practice.
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS), consisting of two 7-item subscales (HADS-A and HADS-D), each ranging from 0 to 21. Baseline anxiety and/or depression status will be the exposure of interest. Psychological assessments will be repeated at 3, 6, and 12 months after treatment initiation. No study-assigned anticancer or psychological treatment will be administered.
Incidence of Treatment Failure Within 24 Months Incidence of Treatment Failure Within 24 Months Incidence of Treatment Failure Within 24 Months Incidence of Treatment Failure Within 24 Months
The primary outcome is the proportion of participants experiencing treatment failure within 24 months after initiation of anticancer treatment. Treatment failure is defined as the first occurrence of any of the following events: (1) disease progression or relapse, assessed according to the Lugano 2014 criteria for lymphoma or the International Myeloma Working Group (IMWG) criteria for multiple myeloma; (2) death from any cause; or (3) premature discontinuation of planned anticancer treatment due to treatment-related toxicity or patient preference. The incidence of treatment failure will be compared between participants with baseline anxiety and/or depression (HADS-A ≥8 or HADS-D ≥8) and those without either condition (both HADS-A and HADS-D below 8). Risk ratios (RRs) and 95% confidence intervals will be estimated.
Time frame: From treatment initiation through 24 months.
Progression-Free Survival (PFS)
PFS is defined as the time from initiation of anticancer treatment to the first documented disease progression, relapse, or death from any cause, whichever occurs first. Disease progression will be assessed according to the Lugano 2014 criteria for lymphoma and IMWG criteria for multiple myeloma. PFS will be estimated using the Kaplan-Meier method and compared between participants with and without baseline anxiety and/or depression. Hazard ratios (HRs) and 95% confidence intervals will be reported.
Time frame: From treatment initiation through 24 months.
Overall Survival (OS)
OS is defined as the time from initiation of anticancer treatment to death from any cause. Survival outcomes will be estimated using the Kaplan-Meier method and compared between participants with and without baseline anxiety and/or depression. Hazard ratios (HRs) and 95% confidence intervals will be reported.
Time frame: From treatment initiation through 24 months.
Overall Response Rate (ORR)
ORR is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) or better during anticancer treatment. Treatment response will be evaluated according to the Lugano 2014 criteria for lymphoma and IMWG response criteria for multiple myeloma. ORR will be compared between participants with and without baseline anxiety and/or depression.
Time frame: From treatment initiation through 24 months; response assessments every 3-6 months.
Complete Response Rate (CR Rate)
The complete response rate is defined as the proportion of participants achieving a complete response during anticancer treatment, as assessed according to the Lugano 2014 criteria for lymphoma and IMWG response criteria for multiple myeloma. Complete response rates will be compared between participants with and without baseline anxiety and/or depression.
Time frame: From treatment initiation through 24 months; response assessments every 3-6 months.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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