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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03430492
• Other study ID #: SCAN-B Resilience
• Status: Active, not recruiting
• Start date: February 15, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 985
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
Sweden	Hallands Hospital Halmstad	Halmstad	Halland
Sweden	Helsingborgs hospital	Helsingborg	Skåne
Sweden	Blekinge County Hospital	Karlskrona	Blekinge
Sweden	Central Hospital Växjö	Växjö	Småland

Sponsors (5)

Lead Sponsor	Collaborator
Lund University	CREATE Health Cancer Centre, Gunnar Nilsson's Cancer Foundation, Mats Paulssons stiftelse, org. nr 802423-3150, Vinnova

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Axelsson U, Ryden L, Johnsson P, Eden P, Mansson J, Hallberg IR, Borrebaeck CAK. A multicenter study investigating the molecular fingerprint of psychological resilience in breast cancer patients: study protocol of the SCAN-B resilience study. BMC Cancer. 2018 Aug 6;18(1):789. doi: 10.1186/s12885-018-4669-y. — View Citation

Mohlin A, Axelsson U, Bendahl PO, Borrebaeck C, Hegardt C, Johnsson P, Rahm Hallberg I, Ryden L. Psychological Resilience and Health-Related Quality of Life in Swedish Women with Newly Diagnosed Breast Cancer. Cancer Manag Res. 2020 Nov 24;12:12041-12051. — View Citation

Mohlin A, Bendahl PO, Hegardt C, Richter C, Hallberg IR, Ryden L. Psychological Resilience and Health-Related Quality of Life in 418 Swedish Women with Primary Breast Cancer: Results from a Prospective Longitudinal Study. Cancers (Basel). 2021 May 6;13(9) — View Citation

Saal LH, Vallon-Christersson J, Hakkinen J, Hegardt C, Grabau D, Winter C, Brueffer C, Tang MH, Reutersward C, Schulz R, Karlsson A, Ehinger A, Malina J, Manjer J, Malmberg M, Larsson C, Ryden L, Loman N, Borg A. The Sweden Cancerome Analysis Network - Breast (SCAN-B) Initiative: a large-scale multicenter infrastructure towards implementation of breast cancer genomic analyses in the clinical routine. Genome Med. 2015 Feb 2;7(1):20. doi: 10.1186/s13073-015-0131-9. eCollection 2015. — View Citation

Velickovic K, Borrebaeck CAK, Bendahl PO, Hegardt C, Johnsson P, Richter C, Ryden L, Hallberg IR. One-year recovery from breast cancer: Importance of tumor and treatment-related factors, resilience, and sociodemographic factors for health-related quality — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The association between psychological resilience and biomolecular signatures in breast cancer patients	Measured by CD-RISC and bimolecular techniques.	All patients enrolled 2019-12-31. Analysis 2020-2022
Secondary	The association between psychological resilience and quality of life at baseline in breast cancer patients	Measured by CD-RISC and SF-36	All patients enrolled 2019-12-31. Analysis 2020-2022
Secondary	The association between psychological resilience and quality of life one year after diagnosis in breast cancer patients	Measured by CD-RISC and SF-36	Patients followed up one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2022
Secondary	The association between psychological resilience and recovery/rehabilitation five years after	Measured by CD-RISC and study specific questionnaire based on the Swedish national cancer rehabilitation guidelines.	Patients followed up five years from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024
Secondary	The association between psychological resilience and prognosis in breast cancer patients	Measured by CD-RISC correlated to register data	Patients followed up one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024
Secondary	The association between psychological resilience and clinicopathological characteristics	Measured by CD-RISC and correlated to register data	All patients enrolled 2019-12-31. Analysis 2020-2024
Secondary	The association between quality of life and clinicopathological characteristics	Measured by SF-36 and correlated to register data	Patients followed one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024

External Links

•   SCAN-B homepage