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| Name | Class |
|---|---|
| Ligue contre le cancer, France | OTHER |
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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.
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 :
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) :
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 :
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Groupe 1 | Other | G1 : Motivational Intervention group |
|
| Groupe 2 | Other | G2 : Educational advises group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Marion BARRAULT-COUCHOURON, PhD | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonie | Bordeaux | 33076 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | 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. |
| FG001 | Arm 2 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Only patients with available data at 3 months | Posted | Count of Participants | Participants | 3 months |
|
Adverse events were not collected for this study.
Adverse events were not collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Groupe 1 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marion Barrault Couchouron, Coordinating Investigator | Institute Bergonie | 0556337805 | m.barrault@bordeaux.unicancer.fr |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 15, 2015 | Mar 25, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064424 | Tobacco Use |
| D019966 | Substance-Related Disorders |
| D000073599 | Health Risk Behaviors |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| 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. |
|
| 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 :
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 :
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 |
| BG001 | Arm 2 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Current family situation | Count of Participants | Participants |
|
| Number of children | Mean | Standard Deviation | Child |
|
| Level of education | Count of Participants | Participants |
|
| Profession | Count of Participants | Participants |
|
| Type of cancer | Count of Participants | Participants |
|
| Tumor extension stage | Tumor extension T stage ranges from T0 (no primary tumor) to T4 (tumor invading an organ) | Count of Participants | Participants |
|
| Past treatment(s) | Count of Participants | Participants |
|
| Spouse's AUDIT-C score | 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. | Mean | Standard Deviation | scores on a scale |
|
| Currently, how many cigarettes per day do you smoke on average? | Among smokers only (N=54) | Mean | Standard Deviation | Cigarettes per day |
|
| Currently, how many cigarettes per day does the patient's spouse smoke on average? | For smokers only (N=54) | Mean | Standard Deviation | Cigarettes |
|
| In the past year, how often did the patient's spouse smoke? | Missing frequency = 23 | Count of Participants | Participants |
|
| DSM5 - Substance-related or addictive disorders (whole life) | The Diagnostic and Statistical Manual of Mental Disorders, fifth edition, published by the American Psychiatric Association (APA) is a taxonomic and diagnostic tool. | Count of Participants | Participants |
|
| DSM5 - Substance-related or addictive disorders (whole life) | The Diagnostic and Statistical Manual of Mental Disorders, fifth edition, published by the American Psychiatric Association (APA) is a taxonomic and diagnostic tool. | Only in patients with substance-related or addictive disorders (N=74) | Count of Participants | Participants |
|
| DSM5 - Whole Life | The Diagnostic and Statistical Manual of Mental Disorders, fifth edition, published by the American Psychiatric Association (APA) is a taxonomic and diagnostic tool. | Count of Participants | Participants |
|
| DSM5 - Substance-related or addictive disorders (current life) | The Diagnostic and Statistical Manual of Mental Disorders, fifth edition, published by the American Psychiatric Association (APA) is a taxonomic and diagnostic tool. | Count of Participants | Participants |
|
| DSM5 - Current Life - Substance-related or addictive disorders | Only for patient with substance-related or addictive disorders (N=38) | Count of Participants | Participants |
|
| DSM5 - Substance-related or addictive disorders (Current Life) | The Diagnostic and Statistical Manual of Mental Disorders, fifth edition, published by the American Psychiatric Association (APA) is a taxonomic and diagnostic tool. | Count of Participants | Participants |
|
| Electronic cigarettes | Among smokers only (N=54) | Count of Participants | Participants |
|
| Type of consumption of electronic cigarettes | Among electronic cigarette smokers only (N=5) | Count of Participants | Participants |
|
| Ongoing psychotropic treatment(s) | Count of Participants | Participants |
|
| Current monitoring with regard to behaviour/emotional state | Count of Participants | Participants |
|
| Type of professional | In patients with current monitoring of behaviour/emotional state (N=29) | Count of Participants | Participants |
|
| 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. | Mean | Standard Deviation | scores on a scale |
|
| Score Audit categorical variable (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 | Count of Participants | Participants |
|
| Fagerström score | Fagerström test is a screening for alcohol consumption. This score ranges from 0 (Not/Very low dependency) to 10 (Very high dependency). | In smokers only (N=54) | Mean | Standard Deviation | scores on a scale |
|
| MADRS Score (Quantitative variable) | MADRS (Montgomery and Asberg Depression Rating Scale) range from 0 (Normothymic) to 60 (medium depression). | Mean | Standard Deviation | scores on a scale |
|
| MADRS Score (Categorical variable) | MADRS (Montgomery and Asberg Depression Rating Scale) range from 0 (Normothymic) to 60 (medium depression). | Count of Participants | Participants |
|
| Score of Hamilton | 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. | Mean | Standard Deviation | scores on a scale |
|
| HEIQ (health Education Impact Questionnaire) 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 . | Mean | Standard Deviation | scores on a scale |
|
| Standardised Quality of Life Scores (EORTC - QLQ-C30) | 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 | Mean | Full Range | Standardized scores on a scale |
|
| OG001 | Arm 2 | 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. |
|
|
| Primary | 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). | Only patients with available data at 3 months and 6 months | Posted | Number | participants | 3 months and 6 months |
|
|
|
| Secondary | 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). | Patients with tobacco or alcohol consumption at baseline and available data at 3 months | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | 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. | Patients with tobacco or alcohol consumption at baseline and data available at 3 months and 6 months | Posted | Count of Participants | Participants | 3 months and 6 months |
|
|
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| Secondary | Number of Patients Per Current Treatments at Baseline | Only patients with available data at baseline | Posted | Count of Participants | Participants | Baseline |
|
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| Secondary | Number of Patients Per Current Treatments at 3 Months | Only patients with available data at 3 months | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Patients Per Current Treatments at 6 Months | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Baseline, 3 months and 6 months |
|
|
|
| Secondary | Number of Patients Who Has Current Monitoring With Regard to Behaviour/Emotional State | Current monitoring with regard to behaviour/emotional state | Posted | Count of Participants | Participants | Baseline, 3 months and 6 months |
|
|
|
| Secondary | 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 | Patients with current monitoring with regard to behaviour/emotional state | Posted | Count of Participants | Participants | Baseline |
|
|
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| Secondary | 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 | Patients with current monitoring with regard to behaviour/emotional state | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | 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 | Patients with current monitoring with regard to behaviour/emotional state | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Currently, How Many Cigarettes Per Day do You Smoke on Average? | Only smokers who have completed form at baseline, 3 months and 6 months. | Posted | Mean | Standard Deviation | Cigarettes per day | Baseline, 3 months and 6 months |
|
|
|
| Secondary | Number of Patients Who Consume Electronic Cigarettes | Only smokers at baseline (N=54), 3 months (N=37) and 6 months (N=30). | Posted | Count of Participants | Participants | Baseline, 3 months and 6 months |
|
|
|
| Secondary | Type of Consumption of Electronic Cigarettes | Patient with electronic cigarette use and who answered the form | Posted | Count of Participants | Participants | Baseline, 3 months and 6 months |
|
|
|
| Secondary | 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). | In smokers only (N=54 smokers at baseline) | Posted | Mean | Standard Error | score on a scale | Baseline, 3 months, 6 months |
|
|
|
| Secondary | 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). | 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). | Posted | Mean | Standard Error | score on a scale | Baseline, 3 months, 6 months |
|
|
|
| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months and 6 months |
|
|
|
| Secondary | Standardised Quality of Life Scores (EORTC - QLQ-C30) | QLQ-C30 questionnaire (EORTC) assesses quality of life across 15 dimensions :
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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 3 months |
|
|
|
| Secondary | Standardised Quality of Life Scores (EORTC - QLQ-C30) | QLQ-C30 questionnaire (EORTC) assesses quality of life across 15 dimensions :
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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 6 months |
|
|
|
| Secondary | 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 . | Patients with available score at baseline or 3 months or 6 months. | Posted | Median | Standard Deviation | scores on a scale | Baseline, 3 months, 6 months |
|
|
|
| Secondary | 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. | Patients with available score. | Posted | Median | Standard Deviation | scores on a scale | Baseline, 3 months and 6 months |
|
|
|
| Secondary | Satisfaction Questionnaire | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Groupe 2 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
| Married |
|
| Divorced |
|
| Widowed |
|
| High school diploma to bachelor's degree (included) |
|
| Higher than bachelor's degree |
|
| Company's exécutives and higher intellectual profession |
|
| Intermediate professions |
|
| Employees |
|
| Labor |
|
| Pensioners |
|
| Economically inactive |
|
| Other |
|
| T1 |
|
| T2 |
|
| T3 |
|
| T4 |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Every day or almost every day |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Missing |
|
| Yes |
|
| Missing |
|
| Yes |
|
| Missing |
|
| Yes |
|
| Missing |
|
| Yes |
|
| Missing |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Harmful consumption |
|
| Probable dependency |
|
| Depression Medium |
|
| Missing |
|
| Missing |
|
| Missing |
|
| Yes |
|
| Chemotherapy |
|
| Radiotherapy |
|
| Hormonotherapy |
|
| No treatment |
|
| Yes |
|
| Chemotherapy |
|
| Radiotherapy |
|
| Hormonotherapy |
|
| No treatment |
|
| Yes |
|
| Chemotherapy |
|
| Radiotherapy |
|
| Hormonotherapy |
|
| No treatment |
|
| Missing |
|
| 3 months |
|
| 6 months |
|
| Yes |
|
| 3 months |
|
| 6 months |
|
| Psychiatrist |
|
| Health professional specialising in tobaccoology and addiction |
|
| Other professional |
|
| Psychiatrist |
|
| Health professional specialising in tobaccoology and addiction |
|
| Other professional |
|
| Psychiatrist |
|
| Health professional specialising in tobaccoology and addiction |
|
| Other professional |
|
| 6 months |
|
| 3 months |
|
|
| 6 months |
|
|
| Yes |
|
| 3 months |
|
|
| 6 months |
|
|
| Without nicotine |
|
| 3 months |
|
|
| 6 months |
|
|
| 3 months |
|
|
| 6 months |
|
|
| 6 months |
|
| 6 months |
|
| 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 |
|
|
| 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 |
|
|
| 6 months |
|
| 6 months |
|
| Yes |
|
| Don't know |
|
| Would it be useful to ask cancer patients about their alcohol/tobacco consumption behaviour |
|
| Would you have liked the questions on consumption to have been asked at another time? |
|
| 5 |
|
| 6 |
|
| 7 |
|
| 8 |
|
| 9 |
|
| 10 |
|