A multicenter study investigating the molecular fingerprint of psychological resilience in breast cancer patients: study protocol of the SCAN-B resilience study

Abstract

Background: Individual patients differ in their psychological response when receiving a cancer diagnosis, in this case breast cancer. Given the same disease burden, some patients master the situation well, while others experience a great deal of stress, depression and lowered quality of life. Patients with high psychological resilience are likely to experience fewer stress reactions and better adapt to and manage the life threat and the demanding treatment that follows the diagnosis. If this phenomenon of mastering difficult situations is reflected also in biomolecular processes is not much studied, nor has its capacity for impacting the cancer prognosis been addressed. This project specifically aims, for the first time, to investigate how a breast cancer patient's psychological resilience is coupled to biomolecular parameters using advanced "omics" and, as a secondary aim, whether it relates to prognosis and quality of life one year after diagnosis.

Method: The study population consists of newly diagnosed breast cancer patients enrolled in the Sweden Cancerome Analysis Network - Breast (SCAN-B) at four hospitals in Sweden. At the time of cancer diagnosis, the patient fills out the standardized method to measure psychological resilience, the "Connor-Davidson Resilience scale" (CD-RISC), the quality of life measure SF-36, as well as providing social and socioeconomic variables. In addition, one blood sample is collected. At the one-year follow-up, the patient will be subjected to the same assessments, and we also collect information regarding smoking, exercise habits, and BMI, as well as patients' trust in the treatment and their satisfaction with the care and treatment.

Discussion: This explorative hypothesis-generating project will pave the way for larger validation studies, potentially leading to a standardized method of measuring psychological resilience as an important parameter in cancer care. Revealing the body-mind interaction, in terms of psychological resilience and quality of life, will herald the development of truly personalized psychosocial care and cancer intervention treatment strategies.

Trial registration: This is a retrospectively registered trial at ClinicalTrials.gov, ID: NCT03430492 on February 6, 2018.

Keywords: Biomolecular parameters; Body and mind; Breast cancer; CD-RISC; Epigenetics; Psychological resilience; Quality of life; SF36.

Conflict of interest statement

Ethical approval was obtained from the ethics committee at Lund University (original study file no. 2009/658, the following amendments are also approved: 2010/383 (expansion of sites for SCAN-B, including Blekinge County Hospital, Central Hospital Växjö and Hallands Hospital Halmstad), 2012/58 (updated patient information for SCAN-B v3), 2015/277 (updated patient information for SCAN-B v4), 2015/522 (The SCAN-B Resilience study), 2017/875 (The SCAN-B Resilience study in Helsingborg) and 2017/88 (The one-year follow up of SCAN-B Resilience).). “The committee sees no ethical problems to approve the planned study with the condition that samples sent abroad should be returned to a Biobank in Sweden after conducting analyses and that the consent is signed by the person who provided the information”. All patients must give written informed consent to participate in the study. Participation in the SCAN-B Resilience study is voluntary, and the participants have the right at any time, without any reason, to cancel their attendance.

Not applicable.

The authors declare that they have no competing interests. The study has received governmental funding and has thus been peer-reviewed by the funding body VINNOVA.

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