Effectiveness of Screening and Brief Interventions for Alcohol and/or Tobacco During Breast Cancer Treatment: A Phase III, Pilot Prospective Randomized Trial (ONKODETOX)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institut Bergonié
- Enrollment
- 104
- Locations
- 2
- Primary Endpoint
- Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months
Study Overview
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.
Detailed Description
Context :
It is now well documented that alcohol and tobacco reduce the effectiveness of a treatment, increase the side effects, favor the recurrence and/or secondary cancers and affects the quality of life of patients treated for cancer, including breast cancer. The announcement of the disease could create a window of opportunity for change in lifestyle for patients. The 2014-2019 French Cancer Plan emphasizes the need for the implementation of prevention and risk reduction related to alcohol and tobacco. A screening, brief motivational and referral to treatment program, specifically dedicated to oncology can be public health approach aiming to reduce the harmful consequences of substance misuse and improving the prognosis and quality of life of consumers at risk.
Main objective :
Evaluate effectiveness of a brief motivational intervention for alcohol and/or tobacco in short (3 month) and medium (6 month) terms in breast cancer patients, in a prospective randomized pilot study.
Secondary objectives :
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months
Time Frame: 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).
Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months and Maintained at 6 Months
Time Frame: 3 months and 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).
Secondary Outcomes
- Currently, How Many Cigarettes Per Day do You Smoke on Average?(Baseline, 3 months and 6 months)
- Type of Consumption of Electronic Cigarettes(Baseline, 3 months and 6 months)
- Number of Patients With Decreased Alcohol and/or Tobacco Consumption(3 months and 6 months)
- Number of Patients Per Current Treatments at 6 Months(6 months)
- Number of Patients Per Current Treatments at 3 Months(3 months)
- Number of Patients Who Continued Psychotropic Treatment(s) at Baseline, 3 Months and 6 Months(Baseline, 3 months and 6 months)
- Number of Patients Who Has Current Monitoring With Regard to Behaviour/Emotional State(Baseline, 3 months and 6 months)
- Number of Patients by Type of Professional Monitored for Behaviour/Emotional State at 6 Months(6 months)
- AUDIT Score at Baseline, 3 Months, and 6 Months(Baseline, 3 months, 6 months)
- Number of Patients With Individual Decreased of Alcohol and/or Tobacco Consumption(3 months)
- Number of Patients Per Current Treatments at Baseline(Baseline)
- HEIQ Score(Baseline, 3 months, 6 months)
- Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at Baseline(Baseline)
- Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at 3 Months(3 months)
- Satisfaction Questionnaire(3 months)
- Motivation Score to Change Consumption Habits (Alcohol/Tobacco)(Baseline, 3 months and 6 months)
- Number of Patients Who Consume Electronic Cigarettes(Baseline, 3 months and 6 months)
- Score of Hamilton(Baseline, 3 months and 6 months)
- Fagerström Score(Baseline, 3 months, 6 months)
- MADRS Score(Baseline, 3 months, 6 months)
- Standardised Quality of Life Scores (EORTC - QLQ-C30)(6 months)
- On a Scale of 1 to 10 How Would You Rate Your Overall Satisfaction With Having Benefited From a Brief Intervention at the Bergonié Institute?(3 months)