Promoting Men's Adherence to BRCA1/2 Germline Genetic Testing

NCT04683068 | Completed

• 1 other identifier: R1249/20-IEO1314
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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 have not received much attention since now. They are under-tested compared to women and the communication is not tailored on their needs. Research on the psychological determinants of men's informed decision-making is particularly lacking as well as experimental evidence on the efficacy of tailored messages on men's needs. Applying principles of the Health Action Process Approach (HAPA), the present protocol proposes a study with the aim to test psychological variables influencing men's decision-making. Moreover, the proposed research intends to test the efficacy of two messages through a randomized experimental study. 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. 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, policymakers, and public health managers about the communication strategy for men and about the psychological variables influencing decision-making.

Conditions

BRCA1 Mutation; BRCA2 Mutation; Psychosocial Factors

Outcome Measures

Primary Outcomes (1)

• Intention to undergo genetic testing

  The intention of undergoing genetic testing is measured through three items evaluating the urge to engage the behavior. Example of item is: "In the next few months, do you have the intention of planning a genetic screening?". Response options are on a 5-point Likert scale.

  2-3 weeks after the intervention exposure

Secondary Outcomes (1)

• Action

  Until 3 months after the intervention exposure

Study Arms (2)

First-person gain-framed self-referred messages

ACTIVE COMPARATOR

This group receives a message in which the main character is a man who speaks in first-person. The character is a man with a sister with a BRCA germline mutation. After this common introduction, the content of the messages becomes different. Group 1 receives a self-referred narrative message in which the protagonist explains that he has decided to have a genetic test to discover BRCA germline mutation. He then explains the reasons why this decision is important to himself (e.g., implementing preventive behaviors) and what are the possible benefits for the individual.

Behavioral: Message comparison

First-person gain-framed family-referred messages

EXPERIMENTAL

This group receives a message in which the main character is a man who speaks in first-person. The character is a man with a sister with a BRCA germline mutation. After this common introduction, the content of the messages becomes different. Group 2 receives a family-referred narrative message in which the frame is similar to the previous message, but the character this time explains what are that the benefits for his family and why his decision to have a genetic test is important to them.

Behavioral: Message comparison

Interventions

Message comparison BEHAVIORAL

Message comparison

First-person gain-framed family-referred messages; First-person gain-framed self-referred messages

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male relatives of patients with an established germline genetic mutation (pathogenic or likely pathogenic variants) of the BRCA1 and / or BRCA2 genes
• Aged ≥ 18
• Able to give informed consent
• Able to read, speak, and understand Italian

You may not qualify if:

• BRCA1 and / or BRCA2 germline genetic screening load detected
• Diagnosis of breast, pancreatic, or prostate cancer

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Onocolgy

Milan, MI, 20141, Italy

Location

Related Publications (1)

• Petrocchi S, Ongaro G, Calvello M, Feroce I, Bonanni B, Pravettoni G. 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. PLoS One. 2022 Apr 8;17(4):e0266327. doi: 10.1371/journal.pone.0266327. eCollection 2022.

  PMID: 35395021 DERIVED

Study Officials

• Serena Petrocchi

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: January 10, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 13, 2022

Record last verified: 2022-05

Locations

IT (1)