Clinical trial NCT04007549: Brief Intervention for Tobacco and Alcohol Risk Reduction for Couple During Breast Cancer Treatment.
Official title: Tobacco and Alcohol Risk Reduction for Women Treated for Breast Cancer and Partner Involvement : Benefits of a Brief Motivational Couple-based Intervention.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Smoking Cessation
Alcohol Use, Unspecified
Keywords: Breast cancer
Smoking cessation
Alcohol risk reduction
Couple intervention
Screening
Brief intervention
Referral to treatment
Randomized Trial
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
First posted: 2019-07-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Screening, Brief Intervention and Referral to Treatment (SBIRT)
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tobacco 7-day point prevalence abstinence (PPA) at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Tobacco 7-day point prevalence abstinence (PPA) at 6 months
timeFrame: 6 weeks
measure: Tobacco 7-day point prevalence abstinence (PPA) at 6 months
timeFrame: 3 months
measure: Quality of life as per EORTC QLQ-C30
timeFrame: 6 months
measure: Quality of life as per EORTC QLQ-C30
timeFrame: 6 weeks
measure: Quality of life as per EORTC QLQ-C30
timeFrame: 3 months
measure: Nicotine dependence measured using the Fageström (1978) test
timeFrame: 6 months
measure: Nicotine dependence measured using the Fageström (1978) test
timeFrame: 6 weeks
measure: Nicotine dependence measured using the Fageström (1978) test
timeFrame: 3 months
measure: Alcohol consumption based on the AUDIT scale
timeFrame: 6 months
measure: Alcohol consumption based on the AUDIT scale
timeFrame: 6 weeks
measure: Alcohol consumption based on the AUDIT scale
timeFrame: 3 months
measure: Psychological distress Symptom Checklist-90-R
timeFrame: 6 months
measure: Psychological distress Symptom Checklist-90-R
timeFrame: 6 weeks
measure: Psychological distress Symptom Checklist-90-R
timeFrame: 3 months
measure: Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
timeFrame: 6 months
measure: Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
timeFrame: 6 weeks
measure: Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
timeFrame: 3 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
Study officials:
References: