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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A03315-48 | Other Identifier | Agence nationale de sécurité du médicament et des produits de santé (ANSM) |
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Internal organisation reason
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| Name | Class |
|---|---|
| Ligue contre le cancer, France | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual brief motivational intervention | Experimental | Individual brief motivational intervention (IBMI) on tobacco/alcohol risk reduction for the breast cancer patient; the partner receive e-mail or postal brief advices. |
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| Couple-based brief motivational intervention | Active Comparator | Couple-based brief motivational intervention (CBMI) on tobacco/alcohol risk reduction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief motivational interview on tobacco/alcohol risk reduction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco 7-day point prevalence abstinence (PPA) at 6 months | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonie | Bordeaux | 33076 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D016540 | Smoking Cessation |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Screening, Brief Intervention and Referral to Treatment (SBIRT)
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|
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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D004327 | Drinking Behavior |