Sweden Cancerome Analysis Network - Breast (SCAN-B) Coupled to Psychological Resilience
- Conditions
- Breast Cancer
- Registration Number
- NCT03430492
- Lead Sponsor
- Lund University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 985
- 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)
- No diagnosis of breast cancer
- Not consented to be included in the SCAN-B study
- Do not understand the Swedish language
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The association between psychological resilience and biomolecular signatures in breast cancer patients All patients enrolled 2019-12-31. Analysis 2020-2022 Measured by CD-RISC and bimolecular techniques.
- Secondary Outcome Measures
Name Time Method 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 Measured by CD-RISC and SF-36
The association between psychological resilience and quality of life at baseline in breast cancer patients All patients enrolled 2019-12-31. Analysis 2020-2022 Measured by CD-RISC and SF-36
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 Measured by CD-RISC and study specific questionnaire based on the Swedish national cancer rehabilitation guidelines.
The association between quality of life and clinicopathological characteristics Patients followed one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024 Measured by SF-36 and correlated to register data
The association between psychological resilience and clinicopathological characteristics All patients enrolled 2019-12-31. Analysis 2020-2024 Measured by CD-RISC and correlated to register data
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 Measured by CD-RISC correlated to register data
Trial Locations
- Locations (4)
Blekinge County Hospital
🇸🇪Karlskrona, Blekinge, Sweden
Hallands Hospital Halmstad
🇸🇪Halmstad, Halland, Sweden
Helsingborgs hospital
🇸🇪Helsingborg, Skåne, Sweden
Central Hospital Växjö
🇸🇪Växjö, Småland, Sweden