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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Zhijuan Lin, Dr
- 電話番号：+86 15960283462
- メール：zjuan_lin@126.com
研究場所
-
-
Fujian
-
Xiamen、Fujian、中国
- 募集
- the First Affilaited Hospital of Xiamen University
-
コンタクト：
- Zhijuan Lin, Dr
- 電話番号：+86 15960283462
- メール：zjuan_lin@126.com
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Treatment Failure Within 24 Months
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-Free Survival (PFS)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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.
|
協力者と研究者
捜査官
- 主任研究者：Zhijuan Lin, Dr、The First Affiliated Hospital of Xiamen University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- XMDYYYXYK-0722(2)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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