NCT03430492

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
985

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

9 years

First QC Date

February 6, 2018

Last Update Submit

March 17, 2025

Conditions

Keywords

Psychological ResilienceBiomarkersMolecular FingerprintQuality of Life (QoL)Body and MindCD-RISCSF-36

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

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

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

  • 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

  • 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

  • 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

  • The association between psychological resilience and clinicopathological characteristics

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

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study includes only women with newly diagnosed breast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Blekinge County Hospital

Karlskrona, Blekinge County, 37480, Sweden

Location

Hallands Hospital Halmstad

Halmstad, Halland County, 30185, Sweden

Location

Helsingborgs hospital

Helsingborg, Skåne County, 25187, Sweden

Location

Central Hospital Växjö

Vaxjo, Småland, 35185, Sweden

Location

Related Publications (5)

  • 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.

    PMID: 25722745BACKGROUND
  • 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.

    PMID: 30081937BACKGROUND
  • 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.

  • 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.

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carl AK Borrebaeck, Professor

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 13, 2018

Study Start

February 15, 2016

Primary Completion

February 28, 2025

Study Completion

December 31, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations