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

Study Overview
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Brief Summary
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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
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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 : Determine the behavioral and psychopathological specific characteristics of the patient linked to change process and maintain. Define a brief intervention for alcohol/tobacco consumption model adapted and integrated to patient treated for cancer according to psychosocial factors highlighted. The investigators will seek to highlight the benefit of a motivational brief intervention versus standardized educational advice. The specificity of these interventions is to be integrated in an interview integrating a systematic screening of the emotional distress of the patient, of these concerns as well as of his perceived need for aids. Method : This is a randomized clinical trial comparing two interventions. The trial includes 200 primary breast cancer patients with a positive AUDIT-C score and/or are tobacco consumers, randomly placed in two groups : G1 : Motivational Intervention group (N = 100) : Participants in the intervention group benefit 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. G2 : Educational advises group (N = 100) : Participants in this group benefit of brief educational advises (10 minutes interview maximum), and received a pamphlet on the health effects of alcohol and tobacco consumption. For obvious ethical reasons, the investigators selected an intervention in the form of advice concerning the effects of the product and the submission of specific documentation (criteria not retained in the context of the brief intervention model). It did not seem possible to evaluate patients without offering them the possibility of a low threshold intervention. Detailed scripts for each modality of intervention are realized. Measurement : Three sets of measurements are taken at baseline, 3-month and 6 month follow-up. Primary Outcome measures: Clinically significant reduction (beneficial to health) of risk behaviours (alcohol and/or tobacco consumption) : Concerning subjects with only alcohol consumption at baseline : The intervention will be considered effective at 3 months if an individual decrease of 20% in the AUDIT score is observed at 3 months compared to the value collected at baseline; The intervention will be considered effective at 6 months if this 20% reduction is maintained at 6 months, still in relation to the value collected at baseline. The same applies to subjects with only tobacco consumption at baseline: The intervention will be considered effective at 3 months if an individual decrease of 20% in the number of cigarettes consumed per day is observed at 3 months compared to the value collected at baseline; The intervention will be judged effective at 6 months if this 20% reduction is maintained at 6 months, still in relation to the value collected at baseline. Finally, with regard to women with both alcohol and tobacco use at baseline : The intervention will be considered effective if at least one of the two scores (AUDIT or number of cigarettes consumed per day) has decreased by 20% at 3 months (maintained at 6 months) compared to the value collected at baseline, with no increase in the other score. Secondary outcome measures : Individual reduction of around 20% in average daily consumption of alcohol and/or tobacco (calculated on the basis of patients' consumption schedules) between inclusion and the first follow-up at 3 months, and maintenance of this success at the second follow-up at 6 months (with no increase in other consumption if the subject has both alcohol and tobacco consumption at inclusion); Description of the variables relating to the consumption of alcohol, tobacco, the current medico-psychological situation, psychological distress, anxio-depressive symptomatology, willingness to change alcohol and/or tobacco consumption habits; Improved quality of life in the experimental intervention arm compared to the standard intervention arm Study procedure : SCREENING-PRE-INCLUSION: Screening of distress and alcohol/tobacco consumptions is realized when the patients arrive in the oncology department for their chemotherapy treatment, by a research assistant-psychologist. Researchers propose to eligible patients to participate to the study. This first contact permits to check the absence of non-inclusion criteria; to ensure the informed consent of the person (an information and consent note will be given to him) and according to these elements, to define the provisional timetable for participation in the research. T0 - INCLUSION AND RANDOMIZATION The research assistant retrieves the signed consent, ensuring a time available to return if necessary and carries out the research interview/assessment. The randomization is realized following this interview. INTERVENTION: Brief intervention (G1 : Brief motivational intervention or G2 : educational advices) are conducted by the research assistant-psychologist, at the Institut Bergonié or by telephone if needed. T1: MONITORING - FOLLOW-UP(3 months) Assessments are repeated, when the patient comes at the Institut Bergonié, by telephone if necessary. T2: MONITORING - FOLLOW-UP (6 months) Assessments are repeated, when the patient comes at the Institut Bergonié, by telephone if necessary. Randomization procedure : The randomization procedure is done via the TENALEA server, managed by the Epidemiological and Clinical Research Unit (UREC) of the Bergonié Institute. Expected results : Highlighting: The efficacy of motivational brief intervention on alcohol and tobacco consumption in patients treated for breast cancer ; versus educational advices intervention. Psychosocial risk factors involved in maintaining problematic consumption or in the rapid relapse of tobacco/alcohol consumption.

Official Title
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Effectiveness of Screening and Brief Interventions for Alcohol and/or Tobacco During Breast Cancer Treatment: A Phase III, Pilot Prospective Randomized Trial (ONKODETOX)

Conditions
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Breast Cancer, Psychology, Social

Intervention / Treatment
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* Behavioral: Motivational Intervention group
* Behavioral: Educational advises group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : 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). Exclusion Criteria : Patients who currently use substances for which a second-line care is already committed. Patients with a Karnofsky index <70.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Groupe 1<br>G1 : Motivational Intervention group | Behavioral: Motivational Intervention group<br>* 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.<br>|
| Other: Groupe 2<br>G2 : Educational advises group | Behavioral: Educational advises group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Individual Decreased of Alcohol and/or Tobacco Consumption | Individual reduction of around 20% in the average daily consumption of alcohol and/or tobacco (calculated on the basis of consumption schedules) between inclusion and the first follow-up at 3 months (with no increase in the other consumption if the subject has both alcohol and tobacco consumption at inclusion). | 3 months | 
| Number of Patients With Decreased Alcohol and/or Tobacco Consumption | Individual reduction of around 20% in the average daily consumption of alcohol and/or tobacco (calculated on the basis of consumption schedules) between inclusion and the first follow-up at 3 months and a continuation of this reduction at the second follow-up at 6 months (with no increase in the other consumption if the subject has both alcohol and tobacco consumption at inclusion). Success depends on alcohol and tobacco level consumption at 3 months and 6 months. | 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 | 
| Number of Patients Who Continued Psychotropic Treatment(s) at Baseline, 3 Months and 6 Months | Ongoing 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 | Current monitoring with regard to behaviour/emotional state | Baseline, 3 months and 6 months | 
| Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at Baseline | Type of professional followed for behaviour/emotional state at baseline | Baseline | 
| Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at 3 Months | Type of professional followed for behaviour/emotional state at 3 months | 3 months | 
| Number of Patients by Type of Professional Monitored for Behaviour/Emotional State at 6 Months | Type of professional followed for behaviour/emotional state at 6 months | 6 months | 
| AUDIT Score at Baseline, 3 Months, and 6 Months | Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score ranges from 0 (No alcohol consumption) to 12 (alcohol dependence). Consumption profiles can be derived from this. Higher scores indicate a worse outcome: alcohol dependence. | Baseline, 3 months, 6 months | 
| Currently, How Many Cigarettes Per Day do You Smoke on Average? |  | Baseline, 3 months and 6 months | 
| Number of Patients Who Consume Electronic Cigarettes |  | Baseline, 3 months and 6 months | 
| Type of Consumption of Electronic Cigarettes |  | Baseline, 3 months and 6 months | 
| Fagerström Score | Fagerström test assesses tobacco consumption and makes it possible to describe patterns of tobacco addiction. Its score ranges from 0 (non-addiction to smoking) to 10 (strong or very strong dependence on tobacco). | Baseline, 3 months, 6 months | 
| MADRS Score | MADRS (Montgomery-Åsberg Depression Rating Scale) assesses the severity of depression in patients with mood disorders. Its score ranges from 0 (normothymic) to 60 (depression). | Baseline, 3 months, 6 months | 
| Score of Hamilton | Hamilton test assesses symptoms of anxiety. Its score ranges from 0 to 56. The higher the score is, the more severe the depression is. | Baseline, 3 months and 6 months | 
| Standardised Quality of Life Scores (EORTC - QLQ-C30) | QLQ-C30 questionnaire (EORTC) assesses quality of life across 15 dimensions : 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health. | 3 months | 
| Standardised Quality of Life Scores (EORTC - QLQ-C30) | QLQ-C30 questionnaire (EORTC) assesses quality of life across 15 dimensions : 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health. | 6 months | 
| HEIQ Score | HEIQ (Health Education Impact Questionnaire) assesses the concept of empowerment (health-promoting behaviours, commitment, social integration, etc.). Its scores range from 0 to 160. Higher scores mean a better health-related empowerment . | Baseline, 3 months, 6 months | 
| Motivation Score to Change Consumption Habits (Alcohol/Tobacco) | This score ranges from 0 to 140. The questionnaire consists of 14 questions on motivation to change alcohol/tobacco consumption habits, each with a response scale ranging from 0 (probably not) to 10 (probably). For each question, a sub-score ranges from 0 to 10 is given and then a total score of motivation to change consumption habits is calculated by adding up all the answers to the 14 items. The higher the score is, greater the patient's willingness to change his or her alcohol/tobacco consumption. | Baseline, 3 months and 6 months | 
| Satisfaction Questionnaire |  | 3 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? | Satisfaction score ranges from 1 to 10. Low scores indicate less satisfaction. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychological intervention Alcohol, Tobacco consumption, Substance use, Health risk behavior, Oncology setting, Supportive care, Women