Tobacco and Alcohol Risk Reduction for Women Treated for Breast Cancer and Partner Involvement : Benefits of a Brief Motivational Couple-based Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Tobacco 7-day point prevalence abstinence (PPA) at 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Individual brief motivational intervention
Individual brief motivational intervention (IBMI) on tobacco/alcohol risk reduction for the breast cancer patient; the partner receive e-mail or postal brief advices.
干预措施: Brief motivational interview on tobacco/alcohol risk reduction (Behavioral)
Couple-based brief motivational intervention
Couple-based brief motivational intervention (CBMI) on tobacco/alcohol risk reduction.
干预措施: Brief motivational interview on tobacco/alcohol risk reduction (Behavioral)
结局指标
主要结局
Tobacco 7-day point prevalence abstinence (PPA) at 6 months
时间窗: 6 months
次要结局
- Quality of life as per EORTC QLQ-C30(3 months)
- Nicotine dependence measured using the Fageström (1978) test(3 months)
- Psychological distress Symptom Checklist-90-R(3 months)
- Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).(3 months)
- Tobacco 7-day point prevalence abstinence (PPA) at 6 months(3 months)
- Alcohol consumption based on the AUDIT scale(3 months)