The Psychology of Chinese Breast Cancer Patients
2021年9月21日 更新者：Ma Fei，MD
Earlier diagnosis of breast cancer in women and the use of systemic adjuvant therapy have increased the likelihood of long term, disease free survival.women
who remain free of breast cancer seem to have levels of functioning and quality of life that are comparable to those of the general female population.It will be assessed the psychology status of women with breast cancer using a clinical interview,
研究概览
详细说明
It conducts a questionnaire survey of 300 patients. The questionnaires used are: Psychological Pain Thermometer DT, Hospital Anxiety and Depression Scale HADS, Quality of Life Scale for Breast Cancer Patients FACT-B, Social Support Rating Scale SSRS. Caregivers should fill in the following scales: Psychological Pain Thermometer DT, Hospital Anxiety and Depression Scale HADS, Caregiver Burden Assessment Scale ZBI. Inclusion criteria: 1,female patients with early breast cancer after surgery; 2,no previous mental and psychological abnormalities; 3,Postoperative and prepare to accept adjuvant chemotherapy ; 4,Patient's know her/his illness .
To explore:
- Psychological status and dynamic changes of patients and caregivers during adjuvant chemotherapy after breast cancer surgery in China.
- The influence of psychological status of Chinese breast cancer patients on adverse reactions during adjuvant chemotherapy.
- Gene susceptibility to psychological abnormalities during adjuvant chemotherapy for breast cancer in China.
研究类型
观察性的
注册 (预期的)
300
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Beijing
-
Beijing、Beijing、中国、100021
- Cancer Hospital, Chinese Academy of Medical Sciences
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Chinese female patients with early breast cancer
描述
Inclusion Criteria:
Age：18~75 years; Early stage breast cancer confirmed by histology examination; Patients had undergone surgery for breast cancer; No distant metastasis; Planned to receive recommended postoperative adjuvant chemotherapy; Voluntarily provided written informed consent.
Exclusion Criteria:
Patients already receiving neoadjuvant chemotherapy before surgery; Patients had metastatic disease at diagnosis; Patients had difficulty understanding the questionnaire or communicating in Chinese; Patients had significant psychiatric or other comorbid disease prohibiting participation; Any other researcher believes that it is not appropriate to participate in this test.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Psychological Distress Thermometer(DT)
大体时间：through study completion, an average of 2 year
|
DT uses to identify sources of distress.
It uses a 0 (no distress) to 10 (extreme distress).
|
through study completion, an average of 2 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Depression Scale (HADS)
大体时间：through study completion, an average of 2 year
|
HADS was divided into an anxiety subscale and a depression subscale.
Each item is scored from 0 (not at all) to 3 (very much) such that total scores on each sub-scale may range from 0-21.
|
through study completion, an average of 2 year
|
|
Social Support Rating Scale (SSRS)
大体时间：through study completion, an average of 2 year
|
Social support was measured by SSRS.
The total score ranges from 12 to 66 points, and higher score indicates higher social support for patients.
|
through study completion, an average of 2 year
|
|
The Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
大体时间：through study completion, an average of 2 year
|
The FACT-B is a 37-item instrument evaluating QoL issues.
The domain scores for physical, social/family and functional well-being range from 0 to 28, the emotional domain scores from 0 to 24 points, the breast cancer- specific subscale domain scores from 0 to 40.
|
through study completion, an average of 2 year
|
|
Zarit Caregiver Burden Interview (ZBI)
大体时间：through study completion, an average of 2 year
|
ZBI Is developed as 29-item self-report scale aimed to assess the subjective burden experienced by an caregiver.
|
through study completion, an average of 2 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Gregorowitsch ML, van den Bongard HJGD, Young-Afat DA, Pignol JP, van Gils CH, May AM, Verkooijen HM. Severe depression more common in patients with ductal carcinoma in situ than early-stage invasive breast cancer patients. Breast Cancer Res Treat. 2018 Jan;167(1):205-213. doi: 10.1007/s10549-017-4495-y. Epub 2017 Sep 11.
- Ng CG, Mohamed S, Kaur K, Sulaiman AH, Zainal NZ, Taib NA; MyBCC Study group. Perceived distress and its association with depression and anxiety in breast cancer patients. PLoS One. 2017 Mar 15;12(3):e0172975. doi: 10.1371/journal.pone.0172975. eCollection 2017.
- de Souza BF, de Moraes JA, Inocenti A, dos Santos MA, Silva AE, Miasso AI. Women with breast cancer taking chemotherapy: depression symptoms and treatment adherence. Rev Lat Am Enfermagem. 2014 Oct;22(5):866-73. doi: 10.1590/0104-1169.3564.2491.
- Andersen BL, Yang HC, Farrar WB, Golden-Kreutz DM, Emery CF, Thornton LM, Young DC, Carson WE 3rd. Psychologic intervention improves survival for breast cancer patients: a randomized clinical trial. Cancer. 2008 Dec 15;113(12):3450-8. doi: 10.1002/cncr.23969.
- Antoni MH, Jacobs JM, Bouchard LC, Lechner SC, Jutagir DR, Gudenkauf LM, Blomberg BB, Gluck S, Carver CS. Post-surgical depressive symptoms and long-term survival in non-metastatic breast cancer patients at 11-year follow-up. Gen Hosp Psychiatry. 2017 Jan-Feb;44:16-21. doi: 10.1016/j.genhosppsych.2016.10.002. Epub 2016 Oct 22.
- Berhili S, Kadiri S, Bouziane A, Aissa A, Marnouche E, Ogandaga E, Echchikhi Y, Touil A, Loughlimi H, Lahdiri I, El Majjaoui S, El Kacemi H, Kebdani T, Benjaafar N. Associated factors with psychological distress in Moroccan breast cancer patients: A cross-sectional study. Breast. 2017 Feb;31:26-33. doi: 10.1016/j.breast.2016.10.015. Epub 2016 Oct 28.
- Giese-Davis J, Waller A, Carlson LE, Groff S, Zhong L, Neri E, Bachor SM, Adamyk-Simpson J, Rancourt KM, Dunlop B, Bultz BD. Screening for distress, the 6th vital sign: common problems in cancer outpatients over one year in usual care: associations with marital status, sex, and age. BMC Cancer. 2012 Oct 2;12:441. doi: 10.1186/1471-2407-12-441.
- Gold M, Dunn LB, Phoenix B, Paul SM, Hamolsky D, Levine JD, Miaskowski C. Co-occurrence of anxiety and depressive symptoms following breast cancer surgery and its impact on quality of life. Eur J Oncol Nurs. 2016 Feb;20:97-105. doi: 10.1016/j.ejon.2015.06.003. Epub 2015 Jul 15.
- Guo X, Xu J, Ying E, Yu Z, Sun T. Correlation between hormone receptor status and depressive symptoms in patients with metastatic breast cancer. Oncotarget. 2017 Feb 2;8(31):50774-50781. doi: 10.18632/oncotarget.15037. eCollection 2017 Aug 1.
- Kaminska M, Kubiatowski T, Ciszewski T, Czarnocki KJ, Makara-Studzinska M, Bojar I, Staroslawska E. Evaluation of symptoms of anxiety and depression in women with breast cancer after breast amputation or conservation treated with adjuvant chemotherapy. Ann Agric Environ Med. 2015;22(1):185-9. doi: 10.5604/12321966.1141392.
- Kim SY, Kim SW, Shin IS, Park MH, Yoon JH, Yoon JS, Kim JM. Changes in depression status during the year after breast cancer surgery and impact on quality of life and functioning. Gen Hosp Psychiatry. 2018 Jan-Feb;50:33-37. doi: 10.1016/j.genhosppsych.2017.09.009. Epub 2017 Sep 29.
- Kim YH, Choi KS, Han K, Kim HW. A psychological intervention programme for patients with breast cancer under chemotherapy and at a high risk of depression: A randomised clinical trial. J Clin Nurs. 2018 Feb;27(3-4):572-581. doi: 10.1111/jocn.13910. Epub 2017 Jul 6.
- So WK, Marsh G, Ling WM, Leung FY, Lo JC, Yeung M, Li GK. Anxiety, depression and quality of life among Chinese breast cancer patients during adjuvant therapy. Eur J Oncol Nurs. 2010 Feb;14(1):17-22. doi: 10.1016/j.ejon.2009.07.005. Epub 2009 Sep 5.
- Zhang J, Zhou Y, Feng Z, Xu Y, Zeng G. Longitudinal Trends in Anxiety, Depression, and Quality of Life During Different Intermittent Periods of Adjuvant Breast Cancer Chemotherapy. Cancer Nurs. 2018 Jan/Feb;41(1):62-68. doi: 10.1097/NCC.0000000000000451.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年4月25日
初级完成 (实际的)
2020年12月31日
研究完成 (预期的)
2021年12月31日
研究注册日期
首次提交
2018年10月22日
首先提交符合 QC 标准的
2021年9月21日
首次发布 (实际的)
2021年9月24日
研究记录更新
最后更新发布 (实际的)
2021年9月24日
上次提交的符合 QC 标准的更新
2021年9月21日
最后验证
2021年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.