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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
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.
Institut Bergonie
Bordeaux, France
Tobacco 7-day point prevalence abstinence (PPA) at 6 months
Time frame: 6 months
Tobacco 7-day point prevalence abstinence (PPA) at 6 months
Time frame: 6 weeks
Tobacco 7-day point prevalence abstinence (PPA) at 6 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months
Nicotine dependence measured using the Fageström (1978) test
Time frame: 6 months
Nicotine dependence measured using the Fageström (1978) test
Time frame: 6 weeks
Nicotine dependence measured using the Fageström (1978) test
Time frame: 3 months
Alcohol consumption based on the AUDIT scale
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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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Psychological distress Symptom Checklist-90-R
SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973.
Time frame: 6 months
Psychological distress Symptom Checklist-90-R
SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973.
Time frame: 6 weeks
Psychological distress Symptom Checklist-90-R
SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973.
Time frame: 3 months
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Time frame: 6 months
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Time frame: 6 weeks
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Time frame: 3 months