跳至主要内容
临床试验/NCT03430492
NCT03430492进行中(未招募)不适用

The Molecular Fingerprint of Psychological Resilience - Implications for Diagnostic and Therapeutic Strategies

Lund University8 个研究点 分布在 1 个国家目标入组 985 人开始时间: 2016年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
985
试验地点
8
主要终点
The association between psychological resilience and biomolecular signatures in breast cancer patients

研究概览

简要总结

This study aims to define the association between psychological resilience and biomolecular signatures in cancer patients and to relate psychological resilience to prognosis, as this could potentially open up a novel avenue of therapeutic interventions, medical as well as psychosocial.

详细描述

Individual patients differ in psychological response when receiving a cancer diagnosis. Given the same disease burden some patients master the situation well and others do experience a great deal of stress, depression and lowered quality of life. A patient's mental resistance after acquiring a threat, like a cancer diagnosis, called psychological resilience, is known to impact the outcome of the disease. Patients with high psychological resilience are likely to experience less stress reactions, and a better adaptation and management of the life threat and the demanding therapeutic interventions. How this phenomenon of mastering difficult situations is reflected also in bio-molecular processes is not much studied and how these have an impact on the cancer prognosis and the effectiveness of treatment is today not fully understood. However, there is evidence that expressing the emotions evoked is an important part of fighting cancer.

Our hypothesis is that patients displaying a high psychological resilience, according to a standardized method "The Connor-Davidson resilience scale" i.e. low stress reactions, low hopelessness and low fatigue, also present a specific pattern of biomolecular signatures in blood, represented by its epigenome, microRNA and proteomic patterns.

This project specifically aims to investigate if breast cancer patient´s psychological resilience can be coupled to bio-molecular parameters, using advanced "omics" and as a secondary aim, if it relates to prognosis and quality of life one year after diagnosis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Newly diagnosed patients with primary breast cancer
  • Patients consented to be included in the SCAN-B study at (Blekinge County Hospital, Central Hospital Växjö and Hallands Hospital Halmstad HBG??
  • Oral and written consent for the SCAN-B Resilience study
  • Age ≥ 18 years
  • Patients that do understand the Swedish language (written and spoken)

排除标准

  • No diagnosis of breast cancer
  • Not consented to be included in the SCAN-B study
  • Do not understand the Swedish language

结局指标

主要结局

The association between psychological resilience and biomolecular signatures in breast cancer patients

时间窗: All patients enrolled 2019-12-31. Analysis 2020-2022

Measured by CD-RISC and bimolecular techniques.

次要结局

  • The association between psychological resilience and quality of life one year after diagnosis in breast cancer patients(Patients followed up one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2022)
  • The association between psychological resilience and quality of life at baseline in breast cancer patients(All patients enrolled 2019-12-31. Analysis 2020-2022)
  • The association between psychological resilience and recovery/rehabilitation five years after(Patients followed up five years from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024)
  • The association between quality of life and clinicopathological characteristics(Patients followed one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024)
  • The association between psychological resilience and clinicopathological characteristics(All patients enrolled 2019-12-31. Analysis 2020-2024)
  • The association between psychological resilience and prognosis in breast cancer patients(Patients followed up one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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