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Study of Anxiety and Depression in Patients With Hematologic Malignancies

2 november 2026 bijgewerkt door: Zhijuan Lin, The First Affiliated Hospital of Xiamen University

An Observational Prospective Cohort Study of Anxiety and Depression in Patients With Hematologic Malignancies

Assessment of Anxiety and Depression Status in Patients with Hematologic Malignancies

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

100

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Fujian
      • Xiamen, Fujian, China
        • Werving
        • the First Affilaited Hospital of Xiamen University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  1. Patients with hematologic malignancies who visit the Department of Hematology at the First Affiliated Hospital of Xiamen University from August 2026 onward, including lymphoma, multiple myeloma, and leukemia.
  2. Patients who are able to understand and voluntarily participate in anxiety and depression status assessments.

Exclusion Criteria:

1. Patients with any other conditions considered by the investigator to be inappropriate for participation in this study.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Anxiety and/or Depression Group

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.
Ander: Baseline Anxiety and/or Depression

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.
No Anxiety or Depression Group

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Treatment Failure Within 24 Months
Tijdsspanne: From treatment initiation through 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.
From treatment initiation through 24 months.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-Free Survival (PFS)
Tijdsspanne: From treatment initiation through 24 months.

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.
From treatment initiation through 24 months.
Overall Survival (OS)
Tijdsspanne: From treatment initiation through 24 months.

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.
From treatment initiation through 24 months.
Overall Response Rate (ORR)
Tijdsspanne: From treatment initiation through 24 months; response assessments every 3-6 months.

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.
From treatment initiation through 24 months; response assessments every 3-6 months.
Complete Response Rate (CR Rate)
Tijdsspanne: From treatment initiation through 24 months; response assessments every 3-6 months.

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.
From treatment initiation through 24 months; response assessments every 3-6 months.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The First Affiliated Hospital of Xiamen University

Onderzoekers

  • Hoofdonderzoeker: Zhijuan Lin, Dr, The First Affiliated Hospital of Xiamen University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

20 oktober 2026

Primaire voltooiing (Geschat)

1 december 2030

Studie voltooiing (Geschat)

1 december 2030

Studieregistratiedata

Eerst ingediend

2 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 oktober 2026

Eerst geplaatst (Werkelijk)

20 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • XMDYYYXYK-0722(2)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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