The Effect of the Breast Cancer Risk Reduction Program on Women With High Breast Cancer Risk in Terms of Their Participation in Screening and Their Health Beliefs and Behavior: A Study Protocol for a Randomized Controlled Trial

Abstract

Background: First-degree biological relatives of individuals with breast cancer have a higher risk of breast cancer.

Objective: The purpose of this study was to create a protocol for evaluating the effect of the Breast Cancer Risk Reduction Program (BrCaRRP) on the participation of women at risk in screening and on their health beliefs and risk reduction behaviors.

Methods: The research was planned as a single-site, single-blind randomized controlled experimental study with a parallel group. Participants will be assigned to intervention and control groups using the Stratified Permuted Block Randomization method. The BrCaRRP will be applied to the intervention group within the theoretical framework of the Health Belief Model and the Health Promotion Model. The BrCaRRP is a 12-week program that encompasses 6 meetings, the first being face-to-face and the others via phone. Multidisciplinary experts calculated the content validity index of BrCaRRP as being 0.954 (high); its weighted kappa statistic is 0.70 (high).

Results: The difference in the likelihood of participation in breast cancer screening between the BrCaRRP and control groups will be evaluated after the interventions. Findings will be presented in terms of our hypotheses.

Conclusions: The BrCaRRP is a nurse-led program based on the Health Belief Model and the Health Promotion Model. The BrCaRRP has high content validity and interrater reliability.

Implications for practice: This protocol can be tested as an intervention in a randomized controlled study.

Trial registration: ClinicalTrials.gov NCT04304404.