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

Not Applicable

Withdrawn

• Conditions: Alcohol Use, Unspecified; Breast Cancer; Smoking Cessation
• Interventions: Behavioral: Brief motivational interview on tobacco/alcohol risk reduction

• Registration Number: NCT04007549
• Lead Sponsor: Institut Bergonié

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Study Start: 2019-10
• Primary Completion: 2022-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• for the breast cancer patient: patients treated for a first breast cancer; Karnofsky Index> 70;
• for both patient and partner: ≥18 years old; smoking more than or equal to 1 cigarette/day;
• without ongoing treatment for current substance-related disorders; having a good understanding of the French language;
• able to express consent to benefit from intervention focused on smoking cessation;
• having an email address and internet access at home.

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Exclusion Criteria

• Refusal of the patient that his/her partner participates or refusal of the partner to participate
• Individual deprived of liberty, under guardianship or trusteeship
• Individual with a dementia or psychiatric disorder that could compromise informed consent and commitment in different times of the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual brief motivational intervention	Brief motivational interview on tobacco/alcohol risk reduction	Individual brief motivational intervention (IBMI) on tobacco/alcohol risk reduction for the breast cancer patient; the partner receive e-mail or postal brief advices.
Couple-based brief motivational intervention	Brief motivational interview on tobacco/alcohol risk reduction	Couple-based brief motivational intervention (CBMI) on tobacco/alcohol risk reduction.

Primary Outcome Measures

Name	Time	Method
Tobacco 7-day point prevalence abstinence (PPA) at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Tobacco 7-day point prevalence abstinence (PPA) at 6 months	3 months
Quality of life as per EORTC QLQ-C30	3 months	European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 - Aaronson et al. JNCI 1993
Nicotine dependence measured using the Fageström (1978) test	3 months
Psychological distress Symptom Checklist-90-R	3 months	SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973.
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).	3 months
Alcohol consumption based on the AUDIT scale	3 months	Alcohol Use Disorders Test short version - Saunders JB, Aasland OG, Babor TF, de la Fuente JR and Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption II. Addiction 1993; 88:791-804.

Trial Locations

Locations (1)

Institut Bergonie; 🇫🇷 Bordeaux, France