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

NCT04683068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2022-05-13

No results posted yet for this study

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

Interventions

BEHAVIORAL

Message comparison

Message comparison

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Serena Petrocchi · European Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-10
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04683068 on ClinicalTrials.gov