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

NCT04007549 | Withdrawn DMC

• 2 other identifiers: IB 2017-052017-A03315-48
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Tobacco 7-day point prevalence abstinence (PPA) at 6 months

  6 months

Secondary Outcomes (17)

• 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

  6 months

• Quality of life as per EORTC QLQ-C30

  6 weeks

• Quality of life as per EORTC QLQ-C30

  3 months

Study Arms (2)

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.

Behavioral: Brief motivational interview on tobacco/alcohol risk reduction

Couple-based brief motivational intervention

ACTIVE COMPARATOR

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

Behavioral: Brief motivational interview on tobacco/alcohol risk reduction

Interventions

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.

Couple-based brief motivational intervention; Individual brief motivational intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Bergonié: lead
• Ligue contre le cancer, France: collaborator

Study Sites (1)

Institut Bergonie

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Smoking Cessation; Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Health Behavior; Behavior; Drinking Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Screening, Brief Intervention and Referral to Treatment (SBIRT)

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 5, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)