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

NCT ID: NCT04007549

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2025-10-31

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.

Conditions

Breast Cancer; Smoking Cessation; Alcohol Use, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Brief motivational interview on tobacco/alcohol risk reduction

Intervention Type: 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.

Couple-based brief motivational intervention

Couple-based brief motivational intervention (CBMI) on tobacco/alcohol risk reduction.

Group Type: ACTIVE_COMPARATOR

Brief motivational interview on tobacco/alcohol risk reduction

Intervention Type: 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.

Interventions

Brief motivational interview on tobacco/alcohol risk reduction

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ligue contre le cancer, France

OTHER

Sponsor Role: collaborator

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Bergonie

Bordeaux, , France

Countries

France

Other Identifiers

2017-A03315-48

Identifier Type: OTHER

Identifier Source: secondary_id

IB 2017-05

Identifier Type: -

Identifier Source: org_study_id