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NCT Number: NCT03430492

Sweden Cancerome Analysis Network - Breast (SCAN-B) Coupled to Psychological Resilience

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Blekinge County Hospital, Karlskrona, Blekinge County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. The association between psychological resilience and quality of life at baseline in breast cancer patients

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

    Measured by CD-RISC and SF-36

  2. The association between psychological resilience and quality of life one year after diagnosis in breast cancer patients

    Time frame: Patients followed up one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2022

    Measured by CD-RISC and SF-36

  3. The association between psychological resilience and recovery/rehabilitation five years after

    Time frame: Patients followed up five years from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024

    Measured by CD-RISC and study specific questionnaire based on the Swedish national cancer rehabilitation guidelines.

  4. The association between psychological resilience and prognosis in breast cancer patients

    Time frame: Patients followed up one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024

    Measured by CD-RISC correlated to register data

  5. The association between psychological resilience and clinicopathological characteristics

    Time frame: All patients enrolled 2019-12-31. Analysis 2020-2024

    Measured by CD-RISC and correlated to register data

  6. The association between quality of life and clinicopathological characteristics

    Time frame: Patients followed one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024

    Measured by SF-36 and correlated to register data

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • CREATE Health Cancer Centre
  • Gunnar Nilsson's Cancer Foundation
  • Mats Paulssons stiftelse, org. nr 802423-3150
  • Vinnova

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2018
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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