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Clinical Trials/NCT03430492
NCT03430492
Active, not recruiting
Not Applicable

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

Lund University4 sites in 1 country985 target enrollmentFebruary 15, 2016
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Lund University
Enrollment
985
Locations
4
Primary Endpoint
The association between psychological resilience and biomolecular signatures in breast cancer patients
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2016
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: All patients enrolled 2019-12-31. Analysis 2020-2022

Measured by CD-RISC and bimolecular techniques.

Secondary Outcomes

  • 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)

Study Sites (4)

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