Brief Intervention for Tobacco and Alcohol Risk Reduction for Couple During Breast Cancer Treatment. — IBMC  

Breast Cancer Clinical Trial

Official title: Tobacco and Alcohol Risk Reduction for Women Treated for Breast Cancer and Partner Involvement : Benefits of a Brief Motivational Couple-based Intervention.

Status Not yet recruiting

Clinical Trial Summary

This study will examine the benefits of involving partner in a Screening, Brief Intervention and Referral to Treatment (SBIRT) program for tobacco and alcohol for women treated for breast cancer. Using a two-arm randomized trial (couple brief motivational intervention (CBMI) versus individual brief motivational intervention (IBMI) with repeated measures at 6 weeks, 3 and 6 months.

Clinical Trial Description

Background: Breast cancer is a common disease for which over 80% of women treated will still be in remission five years after diagnostic. They are a population that can benefit from support to reduce the risks associated with tobacco and alcohol consumptions. Moreover, it is well documented that health behaviors are part of a relational context. Thus, intervene on an individual level cannot suffice to apprehend health behaviors from a systemic perspective. Screening Brief Intervention and Referral to Treatment (SBIRT) program are evaluated for many years and are the reference model in health setting. However, despite national and international recommendations, SBIRT implementation in clinical routine is still very limited in oncology setting. Furthermore, intervene on multiple risk behaviors (contributing to many cancers, increasing the risk of second cancer, treatment morbidity and the risk of developing other chronic diseases) is recommended by several recent empirical studies. Involving the partner in the prevention process could help to develop healthy living environments. A SBIRT program, specifically dedicated to the oncological context and involving the partner may help to reduce tobacco and alcohol risk consumption. Methods/design: The study is a two-arm randomized trial including smoking couples. The intervention is a couple brief motivational intervention (CBMI) on tobacco/alcohol risk reduction, delivered in a single session and a booster session one month later. This intervention will be compared with an individual brief motivational intervention (IBMI) consisting a single brief motivational intervention and a booster session one month later, only delivered to the breast cancer patient; and the partner receive e-mail or postal brief advices. Measures are repeated at 6 weeks, 3 and 6 months post-intervention. The primary outcome is tobacco 7-day point prevalence abstinence (PPA) at 6 months. ;

Related Conditions & MeSH terms

• Alcohol Use, Unspecified
• Breast Cancer
• Breast Neoplasms
• Smoking Cessation

• NCT number: NCT04007549
• Study type: Interventional
• Source: Institut Bergonié
• Contact: Marion BARRAULT-COUCHOURON, PhD
• Phone: +33 5.56.33.32.94
• Email: m.barrault@bordeaux.unicancer.fr
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 2019
• Completion date: August 2022