A randomized controlled trial comparing self-referred message to family-referred message promoting men's adherence to evidence-based guidelines on BRCA1/2 germline genetic testing: A registered study protocol

Serena Petrocchi, Giulia Ongaro, Mariarosaria Calvello, Irene Feroce, Bernardo Bonanni, Gabriella Pravettoni, Serena Petrocchi, Giulia Ongaro, Mariarosaria Calvello, Irene Feroce, Bernardo Bonanni, Gabriella Pravettoni

Abstract

Background: This is a registered study protocol on a randomized controlled trial (RCT) testing an intervention aimed to improve men's adherence to evidence-based guidelines on BRCA1/2 germline genetic testing. BRCA1- and BRCA2-associated Hereditary Breast and Ovarian Cancer Syndrome (HBOC) increases the relative and absolute risk of developing breast and ovarian cancer and, to a lesser extent, prostate and pancreatic cancer. Men face BRCA-related cancer risks as women do, although with a different magnitude, and they may also transmit the mutations to their children. Notwithstanding, men are under-tested compared to women and the communication is not tailored on their needs. The present RCT applies principles of the Health Action Process Approach (HAPA) in testing the psychological determinants of the men's adherence to evidence based guidelines on BRCA1/2 germline genetic and testing the efficacy of two messages.

Methods: A total of 264 participants will be involved, among the men's relatives of women with verified germline mutations. The study entails a pre- post- evaluation with randomization of the participants in two conditions corresponding to the two messages.

Discussion: The expected results provide answers related to the impact of action self-efficacy, outcome expectancy (personal or familiar), risk perception, health risk aversion, intolerance of uncertainty, perceived barriers, and coping self-efficacy on informed decision-making. Data gathered from this study may inform health care providers, policy makers, and public health managers about the communication strategy for men and about the psychological variables influencing decision-making.

Trail registration: Name of the Registry: Clinical Trials. Trial registration number: NCT04683068. Date of registration: 16/12/2020. URL of trial registry record: https://www.clinicaltrials.gov/.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Expected relations between variables.
Fig 1. Expected relations between variables.
T1, T2, T3 indicate the three different timeframes of the research.
Fig 2. The three phases of the…
Fig 2. The three phases of the research project.
Fig 3. Flowchart of the RCT.
Fig 3. Flowchart of the RCT.

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