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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Zhijuan Lin, Dr
- Número de telefone: +86 15960283462
- E-mail: zjuan_lin@126.com
Locais de estudo
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Fujian
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Xiamen, Fujian, China
- Recrutamento
- the First Affilaited Hospital of Xiamen University
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Contato:
- Zhijuan Lin, Dr
- Número de telefone: +86 15960283462
- E-mail: zjuan_lin@126.com
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Treatment Failure Within 24 Months
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-Free Survival (PFS)
Prazo: 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)
Prazo: 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.
|
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Overall Response Rate (ORR)
Prazo: 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.
|
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Complete Response Rate (CR Rate)
Prazo: 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.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Zhijuan Lin, Dr, The First Affiliated Hospital of Xiamen University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- XMDYYYXYK-0722(2)
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