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

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ClinicalTrials.gov Identifier: NCT03430492
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : February 16, 2018
Sponsor:
Collaborators:
Vinnova
Mats Paulssons stiftelse, org. nr 802423-3150
Gunnar Nilssons Cancerstiftelse
CREATE Health Cancer Centre
Information provided by (Responsible Party):
Lund University

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
Breast Cancer

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 Type : Observational
Estimated Enrollment : 1000 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 : February 15, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The association between psychological resilience and biomolecular signatures in breast cancer patients [ Time Frame: All patients enrolled 2018-12-31. Analysis 2019 ]
    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 [ Time Frame: All patients enrolled 2018-12-31. Analysis 2018 - 2019 ]
    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 [ Time Frame: All patients enrolled 2019-12-31. Analysis 2019-2020 ]
    Measured by CD-RISC and SF-36

  3. The association between psychological resilience and prognosis in breast cancer patients [ Time Frame: Patients followed one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2019-2020 ]
    Measured by CD-RISC correlated to register data

  4. The association between psychological resilience and clinicopathological characteristics [ Time Frame: All patients enrolled 2018-12-31. Analysis 2018-2019 ]
    Measured by CD-RISC and correlated to register data

  5. The association between quality of life and clinicopathological characteristics [ Time Frame: Patients followed one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2019-2020 ]
    Measured by SF-36 and correlated to register data


Biospecimen Retention:   Samples With DNA
Whole Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study includes only women with newly diagnosed breast cancer
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430492


Contacts
Contact: Ulrika AE Axelsson, PhD+ +46 70-783 44 32 ulrika.axelsson@immun.lth.se

Locations
Sweden
Blekinge County Hospital Recruiting
Karlskrona, Blekinge, Sweden, 37480
Contact: Sandra Svensson    0455-734557    sandra.svensson@ltblekinge.se   
Contact: Monika Sjövall, MD, PhD    0455-73 10 00    Monika.sjovall@ltblekinge.se   
Hallands Hospital Halmstad Recruiting
Halmstad, Halland, Sweden, 30185
Contact: Åsa Nylander    035- 147718    Asa.Nylander@regionhalland.se   
Contact: Ann-Christine Källström, MD    035-13 10 00    Ann-christine.kallstrom@regionhalland.se   
Helsingborgs hospital Recruiting
Helsingborg, Skåne, Sweden, 25187
Contact: Karina Sandström    042-4061519    Karina.Sandstrom@skane.se   
Contact: Anna-Karin Falck, MD, PhD       anna-karin.falck@med.lu.se   
Central Hospital Växjö Recruiting
Växjö, Småland, Sweden, 35185
Contact: Christina Örnberg    0470-58 80 00    christina.ornberg@kronoberg.se   
Contact: Lena Myrskog, MD    0470-58 80 00    Lena.myrskog@kronoberg.se   
Sponsors and Collaborators
Lund University
Vinnova
Mats Paulssons stiftelse, org. nr 802423-3150
Gunnar Nilssons Cancerstiftelse
CREATE Health Cancer Centre
Investigators
Principal Investigator: Carl AK Borrebaeck, Professor Lund University

Additional Information:
Publications of Results:
Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03430492     History of Changes
Other Study ID Numbers: SCAN-B Resilience
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Upon publication, the relevant anonymized individual participant data will be shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lund University:
Psychological Resilience
Biomarkers
Molecular Fingerprint
Quality of Life (QoL)
Body and Mind
CD-RISC
SF-36