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

Sponsor
Lund University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03430492
Collaborator
Vinnova (Other), Mats Paulssons stiftelse, org. nr 802423-3150 (Other), Gunnar Nilsson's Cancer Foundation (Other), CREATE Health Cancer Centre (Other)
985
4
106.5
246.3
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    985 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Molecular Fingerprint of Psychological Resilience - Implications for Diagnostic and Therapeutic Strategies
    Actual Study Start Date :
    Feb 15, 2016
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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.

    4. 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

    5. 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

    6. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Blekinge County Hospital Karlskrona Blekinge Sweden 37480
    2 Hallands Hospital Halmstad Halmstad Halland Sweden 30185
    3 Helsingborgs hospital Helsingborg Skåne Sweden 25187
    4 Central Hospital Växjö Växjö Småland Sweden 35185

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Carl AK Borrebaeck, Professor, Lund University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Lund University
    ClinicalTrials.gov Identifier:
    NCT03430492
    Other Study ID Numbers:
    • SCAN-B Resilience
    First Posted:
    Feb 13, 2018
    Last Update Posted:
    Jul 14, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lund University

    Study Results

    No Results Posted as of Jul 14, 2021