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AzTrials

Breast CancerNCT03430492

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

An observational study of Breast Cancer, run by Lund University at 4 sites in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
How many people
985 participants
Where
4 sitesSweden
Study dates
15 Feb 2016to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Sweden4 sites

  • Hallands Hospital Halmstad

    Halmstad, Halland County, 30185

  • Helsingborgs hospital

    Helsingborg, Skåne County, 25187

  • Blekinge County Hospital

    Karlskrona, Blekinge County, 37480

  • Central Hospital Växjö

    Vaxjo, Småland, 35185

Other trials in Sweden

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Keywords
Psychological Resilience, Biomarkers, Molecular Fingerprint, Quality of Life (QoL), Body and Mind, CD-RISC, SF-36
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured by CD-RISC and bimolecular techniques.

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

Secondary outcomes (6)

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

    Measured by CD-RISC and SF-36

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

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

    Measured by CD-RISC and SF-36

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

  3. 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.

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

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

    Measured by CD-RISC correlated to register data

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

  5. The association between psychological resilience and clinicopathological characteristics

    Measured by CD-RISC and correlated to register data

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

  6. The association between quality of life and clinicopathological characteristics

    Measured by SF-36 and correlated to register data

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2018
  2. Study start15 Feb 2016
  3. Primary completion28 Feb 2025
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
985 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03430492
Sponsor's protocol ID
SCAN-B Resilience
Status last verified
Aug 2026
First submitted
6 Feb 2018
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Upon publication, the relevant anonymized individual participant data will be shared.

Publications

  • 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.

    PubMed 25722745

  • 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.

    PubMed 30081937

  • Richter C, Dethlefsen O, Axelsson U, Lundberg K, Ryden L, Johnsson P, Ringdahl U, Hallberg IR, Borrebaeck CAK. Multilayered Epigenetic Analysis Identifies a Molecular Portrait for Psychological Resilience in Patients With Breast Cancer. Biol Psychiatry Glob Open Sci. 2025 Jun 3;5(5):100545. doi: 10.1016/j.bpsgos.2025.100545. eCollection 2025 Sep.

    PubMed 40697488

  • 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.

    PubMed 34066499

  • 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.

    PubMed 33269004

  • 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.

    PubMed 36052232

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Lund University at 4 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The association between psychological resilience and biomolecular signatures in breast cancer patients (time frame: All patients enrolled 2019-12-31. Analysis 2020-2022). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03430492, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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