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

October 3, 2023 updated by: Lund University

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.

Study Overview

Status

Active, not recruiting

Conditions

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

Enrollment (Actual)

985

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Blekinge
      • Karlskrona, Blekinge, Sweden, 37480
        • Blekinge County Hospital
    • Halland
      • Halmstad, Halland, Sweden, 30185
        • Hallands Hospital Halmstad
    • Skåne
      • Helsingborg, Skåne, Sweden, 25187
        • Helsingborgs Hospital
    • Småland
      • Växjö, Småland, Sweden, 35185
        • Central Hospital Växjö

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The association between psychological resilience and biomolecular signatures in breast cancer patients
Time Frame: All patients enrolled 2019-12-31. Analysis 2020-2022
Measured by CD-RISC and bimolecular techniques.
All patients enrolled 2019-12-31. Analysis 2020-2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The association between psychological resilience and quality of life at baseline in breast cancer patients
Time Frame: All patients enrolled 2019-12-31. Analysis 2020-2022
Measured by CD-RISC and SF-36
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
Time Frame: Patients followed up one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2022
Measured by CD-RISC and SF-36
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
Time Frame: 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.
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
Time Frame: Patients followed up one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024
Measured by CD-RISC correlated to register data
Patients followed up one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024
The association between psychological resilience and clinicopathological characteristics
Time Frame: All patients enrolled 2019-12-31. Analysis 2020-2024
Measured by CD-RISC and correlated to register data
All patients enrolled 2019-12-31. Analysis 2020-2024
The association between quality of life and clinicopathological characteristics
Time Frame: Patients followed one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024
Measured by SF-36 and correlated to register data
Patients followed one year from diagnosis. All patients enrolled 2019-12-31. Analysis 2020-2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2016

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 6, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 13, 2018

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SCAN-B Resilience

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Upon publication, the relevant anonymized individual participant data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe