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

Tobacco and Alcohol Risk Reduction for Women Treated for Breast Cancer and Partner Involvement : Benefits of a Brief Motivational Couple-based Intervention.

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.

Study Overview

• Status: Unknown
• Conditions: Smoking Cessation; Breast Cancer; Alcohol Use, Unspecified
• Intervention / Treatment: Behavioral: Brief motivational interview on tobacco/alcohol risk reduction

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.

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Marion BARRAULT-COUCHOURON, PhD; Phone Number: +33 5.56.33.32.94; Email: m.barrault@bordeaux.unicancer.fr

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonié

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: Couple-based brief motivational intervention; Couple-based brief motivational intervention (CBMI) on tobacco/alcohol risk reduction.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tobacco 7-day point prevalence abstinence (PPA) at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Collaborators: Ligue contre le cancer, France

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Breast cancer; Screening; Smoking cessation; Brief intervention; Randomized Trial; Alcohol risk reduction; Couple intervention; Referral to treatment
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IB 2017-05; 2017-A03315-48 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé (ANSM))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No