Study of Anxiety and Depression in Patients With Hematologic Malignancies
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Zhijuan Lin, Dr
- Telefonnummer: +86 15960283462
- E-Mail: zjuan_lin@126.com
Studienorte
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Fujian
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Xiamen, Fujian, China
- Rekrutierung
- the First Affilaited Hospital of Xiamen University
-
Kontakt:
- Zhijuan Lin, Dr
- Telefonnummer: +86 15960283462
- E-Mail: zjuan_lin@126.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
Inclusion Criteria:
- 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.
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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. |
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of Treatment Failure Within 24 Months
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Progression-Free Survival (PFS)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Zhijuan Lin, Dr, The First Affiliated Hospital of Xiamen University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- XMDYYYXYK-0722(2)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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