Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

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.

Motivational Intervention group

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.

Educational advises group

Marion BARRAULT-COUCHOURON, PhD

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.

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.

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

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

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).

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).

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).

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.

Ongoing psychotropic treatment(s) at baseline, 3 months and 6 months.

Current monitoring with regard to behaviour/emotional state

Type of professional followed for behaviour/emotional state at baseline

Type of professional followed for behaviour/emotional state at 3 months

Type of professional followed for behaviour/emotional state at 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.

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).

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).

Hamilton test assesses symptoms of anxiety. Its score ranges from 0 to 56. The higher the score is, the more severe the depression is.

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.

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 .

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.

Satisfaction score ranges from 1 to 10. Low scores indicate less satisfaction.

Ligue contre le cancer, France

Institut Bergonié

Adverse events were not collected for this study.

G1 : Motivational Intervention group

Motivational Intervention group: 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

G2 : Educational advises group

Educational advises group: 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

Arm 1: Motivational Intervention group

Motivational Intervention group: 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.

Arm 1

Arm 2 : Educational advises group

Educational advises group: 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.

Arm 2

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Current family situation

Number of children

Level of education

Profession

Type of cancer

Tumor extension T stage ranges from T0 (no primary tumor) to T4 (tumor invading an organ)

Tumor extension stage

Surgery

Chemotherapy

Radiotherapy

Hormonotherapy

Without treatment

Past treatment(s)

Alcohol Use Disorders IdentificationTest-Consumption (AUDIT-C) score ranges from 0 (No alcohol consumption) to 12 (alcohol dependence).Consumption profiles can be derived from this.

Here the spouse's AUDIT-C score was presented.

Spouse's AUDIT-C score

Currently, how many cigarettes per day do you smoke on average?

Currently, how many cigarettes per day does the patient's spouse smoke on average?

In the past year, how often did the patient's spouse smoke?

The Diagnostic and Statistical Manual of Mental Disorders, fifth edition, published by the American Psychiatric Association (APA) is a taxonomic and diagnostic tool.

DSM5 - Substance-related or addictive disorders (whole life)

Alcohol

Tobacco

Cannabis

Other

Only in patients with substance-related or addictive disorders (N=74)

Depressive disorders

Bipolar and related disorders

Anxiety disorders

OCD and related

Disorders related to trauma or stressors

Substance-related or Addictive

DSM5 - Whole Life

DSM5 - Substance-related or addictive disorders (current life)

Only for patient with substance-related or addictive disorders (N=38)

DSM5 - Current Life - Substance-related or addictive disorders

DSM5 - Substance-related or addictive disorders (Current Life)

Electronic cigarettes

Among electronic cigarette smokers only (N=5)

Type of consumption of electronic cigarettes

Ongoing psychotropic treatment(s)

Psychologist

Psychiatrist

Health professional specialising in tobaccoology and addiction

Other professional

In patients with current monitoring of behaviour/emotional state (N=29)

Type of professional

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.

AUDIT Score (patient)

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

Score Audit categorical variable (Patient)

Fagerström test is a screening for alcohol consumption. This score ranges from 0 (Not/Very low dependency) to 10 (Very high dependency).

Fagerström score

MADRS (Montgomery and Asberg Depression Rating Scale) range from 0 (Normothymic) to 60 (medium depression).

MADRS Score (Quantitative variable)

MADRS Score (Categorical variable)

The Hamilton Depression Scale is a test for assessing the intensity of depressive symptoms. It ranges from 0 to 56. The higher the score is, the more severe the depression is.

Score of Hamilton

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 .

HEIQ (health Education Impact Questionnaire) score

Physical functioning

Role functioning

Emotional functioning

Cognitive functioning

Social functioning

Fatigue

Nausea and vomiting

Pain

Dyspnoea

Insomnia

Appetite loss

Constipation

Diarrhoea

Financial difficulties

Global health status/QoL (revised)

Standardised QLQ-C30 scoring according to EORTC scoring manual (Fayers et al. EORTC QLQ-C30 scoring manual. 2001).

15 dimensions are presented below. 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.

Patients with available quality of life score

Standardised Quality of Life Scores (EORTC - QLQ-C30)

Dr. Marion Barrault Couchouron, Coordinating Investigator

Success

Success not maintained

Missing

Arm 2: Educational advises group

Educational advises group: 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.

Only patients with available data at 3 months

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

Only patients with available data at 3 months and 6 months

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

Patients with tobacco or alcohol consumption at baseline and available data at 3 months

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

Patients with tobacco or alcohol consumption at baseline and data available at 3 months and 6 months

Number of Patients With Decreased Alcohol and/or Tobacco Consumption

No treatment

Only patients with available data at baseline

Number of Patients Per Current Treatments at Baseline

Number of Patients Per Current Treatments at 3 Months

Number of Patients Per Current Treatments at 6 Months

Baseline

3 months

6 months

Number of Patients Who Continued Psychotropic Treatment(s) at Baseline, 3 Months and 6 Months

Number of Patients Who Has Current Monitoring With Regard to Behaviour/Emotional State

Patients with current monitoring with regard to behaviour/emotional state

Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at Baseline

Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at 3 Months

Number of Patients by Type of Professional Monitored for Behaviour/Emotional State at 6 Months

Arm 1 : Motivational Intervention group

Motivational Intervention group: 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.

AUDIT Score at Baseline, 3 Months, and 6 Months

Only smokers who have completed form at baseline, 3 months and 6 months.

Currently, How Many Cigarettes Per Day do You Smoke on Average?

Only smokers at baseline (N=54), 3 months (N=37) and 6 months (N=30).

Number of Patients Who Consume Electronic Cigarettes

Patient with electronic cigarette use and who answered the form

Type of Consumption of Electronic Cigarettes

In smokers only (N=54 smokers at baseline)

Fagerström Score

Eligible and assessable patients who have completed the MADRS questionnaire at baseline, 3 months and 6 months. For this questionnaire, there were no missing data at each time point (baseline, 3 months and 6 months).

MADRS Score

Eligible and assessable patients who have completed the Hamilton questionnaire at baseline, 3 months and 6 months. For this questionnaire, there were no missing data at each time point (baseline, 3 months and 6 months).

Global health status/QoL

Participants who completed at least one item of the questionnaire. Note that some participants may not have completed the 30 items of the questionnaires, which explains why the number of participants differs for the different items of the questionnaires.

Patients with available score at baseline or 3 months or 6 months.

Spots Global Cancer Trial Database for oncology setting