Effectiveness of Screening and Brief Interventions for Alcohol and Tobacco During Breast Cancer Treatment (ONKODETOX)

NCT03371732 | Completed Results

• 1 other identifier: IB2013-ONKODETOX
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Despite scientific, clinical and political incentives, alcohol and/or tobacco screening and brief intervention (SBI) services are poorly implemented in oncology settings. Motivational brief interventions are recognized as particularly effective in changing health behaviors, especially consumption behaviors. The motivational approach is more and more used in primary care setting but still few studies explore its effectiveness with breast cancer patients. This study aims to compare two intervention arms : educational advices intervention (EAI) versus brief motivational intervention (BMI) for alcohol and/or tobacco consumption in breast cancer women, during their treatment. In this pilot prospective randomized trial, various psychological and behavioral, variables are measured (alcohol and tobacco consumption, distress, anxiety and depressive disorders, quality of life, motivation for change, empowerment) before the brief intervention, and after 3 and 6 month.

Conditions

Breast Cancer; Psychology, Social

Keywords

Psychological intervention Alcohol; Tobacco consumption; Substance use; Health risk behavior; Oncology setting; Women; Supportive care

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months

  Individual decrease of 20% in the AUDIT (Alcohol Use Disorders Identification Test) score observed at 3 months AUDIT test measures alcohol consumption and makes it possible to describe its profiles. Its score ranges from 0 (no consumption) to 28 (alcohol dependence).

  3 months

• Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months and Maintained at 6 Months

  Individual decrease of 20% in the AUDIT score observed at 3 months compared to the value collected at baseline and maintained at 6 months. Success depends on tobacco consumption at 3 months and 6 months. AUDIT test measures alcohol consumption and makes it possible to describe its profiles. Its score ranges from 0 to 28. Its score ranges from 0 (no consumption) to 28 (alcohol dependence).

  3 months and 6 months

Secondary Outcomes (23)

• Number of Patients With Individual Decreased of Alcohol and/or Tobacco Consumption

  3 months

• Number of Patients With Decreased Alcohol and/or Tobacco Consumption

  3 months and 6 months

• Number of Patients Per Current Treatments at Baseline

  Baseline

• Number of Patients Per Current Treatments at 3 Months

  3 months

• Number of Patients Per Current Treatments at 6 Months

  6 months

Study Arms (2)

Groupe 1

OTHER

G1 : Motivational Intervention group

Behavioral: Motivational Intervention group

Groupe 2

OTHER

G2 : Educational advises group

Behavioral: Educational advises group

Interventions

Motivational Intervention group BEHAVIORAL

Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.

Groupe 1

Educational advises group BEHAVIORAL

Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.

Groupe 2

Eligibility Criteria

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

You may qualify if:

• women with primary breast cancer, without ongoing support for substance use.
• An AUDIT-C score \>1 or more than one cigarette smoked per day.
• Individuals able to consent to benefit of intervention focused on substance use. (Karnofsky Index \>70).

You may not qualify if:

• Patients who currently use substances for which a second-line care is already committed.
• Patients with a Karnofsky index \<70.

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; Tobacco Use; Substance-Related Disorders; Health Risk Behaviors

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Chemically-Induced Disorders; Mental Disorders; Health Behavior

Results Point of Contact

• Title: Dr. Marion Barrault Couchouron, Coordinating Investigator
• Organization: Institute Bergonie

m.barrault@bordeaux.unicancer.fr

0556337805

Study Officials

• Marion BARRAULT-COUCHOURON, PhD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: December 13, 2017
• Study Start: March 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: April 1, 2019
• Last Updated: December 2, 2022
• Results First Posted: May 3, 2021

Record last verified: 2022-12

Locations

FR (1)