Clinical trial NCT03430492: Sweden Cancerome Analysis Network - Breast (SCAN-B) Coupled to Psychological Resilience
Official title: The Molecular Fingerprint of Psychological Resilience - Implications for Diagnostic and Therapeutic Strategies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Psychological Resilience
Biomarkers
Molecular Fingerprint
Quality of Life (QoL)
Body and Mind
CD-RISC
SF-36
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Vinnova
name: Mats Paulssons stiftelse, org. nr 802423-3150
name: Gunnar Nilsson's Cancer Foundation
name: CREATE Health Cancer Centre
First posted: 2018-02-13
Enrollment: 985
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SCAN-B Resilience is, as a part of the SCAN-B program, a prospective breast cancer study with established infrastructure for enrollment and follow-ups for patient. The study population is newly diagnosed breast cancer patients enrolled in SCAN-B at the hospitals in Karlskrona, Helsingborg, Växjö and Halmstad.

The INCA register (a information network for cancer care) includes almost 100% of all women diagnosed with breast cancer. Based on comparison with cancer registrations in INCA for 2011-2012, 85 % of all new breast cancer diagnosed women are included in SCAN-B. In April 2017 83% of patients included in SCAN-B were also enrolled in SCAN-B Resilience why a majority (70%) of women diagnosed with breast cancer are enrolled in this study

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.

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

Primary outcomes:
measure: The association between psychological resilience and biomolecular signatures in breast cancer patients
timeFrame: All patients enrolled 2019-12-31. Analysis 2020-2022
Secondary outcomes:
measure: The association between psychological resilience and quality of life at baseline in breast cancer patients
timeFrame: All patients enrolled 2019-12-31. Analysis 2020-2022
measure: The association between psychological resilience and quality of life one year after diagnosis in breast cancer patients
timeFrame: Patients followed up one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2022
measure: The association between psychological resilience and recovery/rehabilitation five years after
timeFrame: Patients followed up five years from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024
measure: The association between psychological resilience and prognosis in breast cancer patients
timeFrame: Patients followed up one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024
measure: The association between psychological resilience and clinicopathological characteristics
timeFrame: All patients enrolled 2019-12-31. Analysis 2020-2024
measure: The association between quality of life and clinicopathological characteristics
timeFrame: Patients followed one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024
Other outcomes:
Locations:
city: Karlskrona
country: Sweden
facility: Blekinge County Hospital
state: Blekinge
city: Halmstad
country: Sweden
facility: Hallands Hospital Halmstad
state: Halland
city: Helsingborg
country: Sweden
facility: Helsingborgs hospital
state: Skåne
city: Växjö
country: Sweden
facility: Central Hospital Växjö
state: Småland
Study officials:
affiliation: Lund University
name: Carl AK Borrebaeck, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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):2233. doi: 10.3390/cancers13092233.
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. doi: 10.2147/CMAR.S268774. eCollection 2020.
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 of life. Front Oncol. 2022 Aug 16;12:891850. doi: 10.3389/fonc.2022.891850. eCollection 2022.