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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Smoking Cessation, Alcohol Use, Unspecified

Intervention / Treatment
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* Behavioral: Brief motivational interview on tobacco/alcohol risk reduction


Participation Criteria
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Eligibility Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Screening, Brief Intervention and Referral to Treatment (SBIRT)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual brief motivational intervention<br>Individual brief motivational intervention (IBMI) on tobacco/alcohol risk reduction for the breast cancer patient; the partner receive e-mail or postal brief advices. | Behavioral: Brief motivational interview on tobacco/alcohol risk reduction<br>* The intervention is a couple brief motivational interview (CBMI) on tobacco/alcohol risk reduction, delivered in a single session and a booster session one month later. It is based on motivational interviewing principals (patient-centered communication, expression of empathy, develops discrepancy, deal with resistance to change, support self-efficacy and autonomy), with feedback on tobacco / alcohol consumption, information delivery and if needed referral to treatment. The intervention also specifically focuses on relational dynamics, and marital support development. This intervention will be compared with a single individual brief motivational intervention (IBMI) and a booster session one month later, only delivered to the patient; and the partner receive e-mail or postal brief advices. All brief interventions will be carried out by the same psychologist trained and supervised for this type of intervention.<br>|
| Active Comparator: Couple-based brief motivational intervention<br>Couple-based brief motivational intervention (CBMI) on tobacco/alcohol risk reduction. | Behavioral: Brief motivational interview on tobacco/alcohol risk reduction<br>* The intervention is a couple brief motivational interview (CBMI) on tobacco/alcohol risk reduction, delivered in a single session and a booster session one month later. It is based on motivational interviewing principals (patient-centered communication, expression of empathy, develops discrepancy, deal with resistance to change, support self-efficacy and autonomy), with feedback on tobacco / alcohol consumption, information delivery and if needed referral to treatment. The intervention also specifically focuses on relational dynamics, and marital support development. This intervention will be compared with a single individual brief motivational intervention (IBMI) and a booster session one month later, only delivered to the patient; and the partner receive e-mail or postal brief advices. All brief interventions will be carried out by the same psychologist trained and supervised for this type of intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco 7-day point prevalence abstinence (PPA) at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco 7-day point prevalence abstinence (PPA) at 6 months |  | 6 weeks | 
| Tobacco 7-day point prevalence abstinence (PPA) at 6 months |  | 3 months | 
| Quality of life as per EORTC QLQ-C30 | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 - Aaronson et al. JNCI 1993 | 6 months | 
| Quality of life as per EORTC QLQ-C30 | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 - Aaronson et al. JNCI 1993 | 6 weeks | 
| Quality of life as per EORTC QLQ-C30 | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 - Aaronson et al. JNCI 1993 | 3 months | 
| Nicotine dependence measured using the Fageström (1978) test |  | 6 months | 
| Nicotine dependence measured using the Fageström (1978) test |  | 6 weeks | 
| Nicotine dependence measured using the Fageström (1978) test |  | 3 months | 
| Alcohol consumption based on the AUDIT scale | 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. | 6 months | 
| Alcohol consumption based on the AUDIT scale | 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. | 6 weeks | 
| Alcohol consumption based on the AUDIT scale | 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. | 3 months | 
| Psychological distress Symptom Checklist-90-R | SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973. | 6 months | 
| Psychological distress Symptom Checklist-90-R | SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973. | 6 weeks | 
| Psychological distress Symptom Checklist-90-R | SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973. | 3 months | 
| Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III). |  | 6 months | 
| Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III). |  | 6 weeks | 
| Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III). |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Smoking cessation, Alcohol risk reduction, Couple intervention, Screening, Brief intervention, Referral to treatment, Randomized Trial