Psychiatric distress enters the hematology endpoint equation
A prospective cohort study from the First Affiliated Hospital of Xiamen University is set to examine a question hematology clinics confront every day but rarely measure with precision: whether anxiety and depression at diagnosis alter the course of hematologic malignancies. The single-center study will enroll about 100 patients newly diagnosed with lymphoma or multiple myeloma, with leukemia also listed among eligible hematologic malignancies, and follow them for at least 24 months while standard anticancer treatment proceeds unchanged.
Baseline psychological burden is the exposure of interest, not an afterthought. Investigators will classify patients using the Hospital Anxiety and Depression Scale, separating those with a HADS-A score of 8 or higher and/or a HADS-D score of 8 or higher from those whose anxiety and depression scores remain below 8 on both subscales. The design is observational, prospective, and intentionally embedded in routine care, which means the study is positioned to reflect the realities of treatment delivery rather than an idealized trial environment.
Treatment failure may capture the biological and behavioral cost of distress
The primary endpoint is treatment failure within 24 months, defined broadly enough to include disease progression or relapse, death from any cause, or early discontinuation of planned anticancer therapy because of toxicity or patient preference. That composite is clinically meaningful because psychological distress can plausibly influence several of those pathways at once. Depression and anxiety may erode adherence, reduce tolerance of difficult regimens, impair symptom reporting, and delay escalation of supportive care. In aggressive blood cancers, those pressures can become consequential quickly.
The study will compare the incidence of treatment failure between patients with baseline distress and those without it, and will estimate risk ratios with 95% confidence intervals. By using a composite endpoint that includes both disease biology and treatment persistence, the protocol acknowledges a central bedside reality: oncology outcomes are not determined by tumor kinetics alone. A patient who stops therapy early because the burden feels unmanageable has already entered a different clinical trajectory, even if the malignant clone itself has not yet changed behavior.
This endpoint choice is direct and practical. It measures what happens when psychology and cancer therapy collide.
Serial HADS testing may map how mood evolves during therapy
Anxiety and depression will not be treated as fixed labels. Participants will complete the Hospital Anxiety and Depression Scale before treatment and again at 3, 6, and 12 months after treatment initiation, creating a longitudinal view of symptom burden during the period when chemotherapy, immunotherapy, or other standard regimens are unfolding. Each HADS subscale contains seven items and ranges from 0 to 21, giving the investigators a structured way to capture changes over time.
That repeated measurement matters because psychological distress in newly diagnosed cancer is dynamic. The first weeks after diagnosis often bring uncertainty, fear, and practical disruption, while later months may add cumulative toxicity, financial strain, and fatigue. Tracking anxiety and depression at several checkpoints can reveal whether baseline distress persists, improves, or intensifies, and whether those trajectories line up with treatment response or discontinuation.
No study-assigned anticancer therapy will be given, and no study-directed psychological intervention is planned. Patients will receive standard anticancer treatment according to routine clinical practice, which keeps the cohort anchored to real-world care patterns. Baseline characteristics, medical history, treatment information, clinical assessments, and study-specific laboratory data will also be collected before and after treatment.
Survival and response endpoints extend the clinical readout
Secondary outcomes broaden the lens beyond treatment failure. The study will evaluate progression-free survival, overall survival, overall response rate, and complete response rate over the same 24-month period. Progression-free survival will be measured from treatment initiation to progression, relapse, or death from any cause, whichever occurs first, and survival analyses will use the Kaplan-Meier method with hazard ratios and confidence intervals reported. Overall survival will follow the same structure, ending at death from any cause.
Response will be assessed using established disease-specific criteria: the Lugano 2014 criteria for lymphoma and International Myeloma Working Group criteria for multiple myeloma. Overall response rate will capture complete response or partial response or better, while complete response rate will isolate the strictest favorable outcome. Those response measures can be especially informative in this setting because they may separate patients whose distress affects adherence or tolerability from those whose disease remains biologically responsive despite psychological burden.
The study’s open-ended clinical value lies in whether distress predicts earlier progression, weaker response, or lower completion of planned therapy. If the association is real, the mechanism may be indirect, mediated by tolerability and adherence, or it may reflect a more complex interaction between stress physiology, immune function, and treatment engagement. Hematologic malignancies already place heavy demands on the body; persistent anxiety and depression can deepen that strain.
A modest sample, but a focused question in a high-burden setting
Enrollment is estimated at 100 patients, a sample size that keeps the study tightly focused but also limits how far the findings can be pushed. The cohort is non-probability sampled from a single center in Xiamen, Fujian, China, and recruitment is listed as ongoing from August 2026 onward. Adults, older adults, and children are eligible, and the study accepts all sexes. Patients must be able to understand and voluntarily participate in the anxiety and depression assessments.
Those details point to an important strength and an important constraint. The strength is clinical specificity: newly diagnosed patients, standardized psychological screening, and a prespecified 24-month window for disease-centered outcomes. The constraint is generalizability. One hospital’s experience may not mirror the case mix, supportive care resources, or psychosocial services of other centers, and the inclusion criteria give the investigator discretion to exclude any patient deemed inappropriate for participation.
Even so, the study addresses a gap that matters in daily practice. Hematology teams often discuss transfusions, marrow response, relapse risk, and toxicity in exacting detail, while emotional distress may be noted informally and left uncaptured in the record. A structured cohort with repeated HADS scoring can turn that missing clinical texture into analyzable data.
Why the bedside conversation could change if the association holds
If baseline anxiety or depression tracks with treatment failure, clinicians may need to treat psychological assessment as part of prognostication rather than as a separate comfort measure. Screening would still not replace disease staging or molecular risk stratification, but it could identify patients who need closer symptom support, more intensive counseling, or earlier integration of psychosocial care while chemotherapy or other standard treatment is underway.
The study does not yet answer whether treating depression or anxiety would alter cancer outcomes, and it does not test a psychological intervention. It is designed to measure association, not prove causality. Even so, a positive signal would strengthen the argument that psychological state belongs inside the hematology care plan from day one, especially when the first months of treatment are when adherence, toxicity, and uncertainty are most likely to collide.
For now, the protocol is a prospective attempt to quantify a relationship clinicians already suspect but rarely measure in a standardized way. The real test will come after follow-up is complete, when treatment failure, progression, survival, and response can be compared against the psychological state recorded at baseline and during therapy.