An interventional study of Motivational Intervention group and Educational advises group in Breast Cancer and Psychology, Social, sponsored by Institut Bergonié. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-02.
Sponsored by Institut Bergonié · Not applicable, Interventional, and Other
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Among 29 studies in Breast Neoplasms by Institut Bergonié — 4 open to participants now, 6 under way, none of them phase 3. Breast Neoplasms · Institut Bergonié.
Among the 29 studies in Breast Neoplasms by Institut Bergonié, this one is the 10th largest by enrollment of the 20 interventional ones that give a count, is one of 4 that started in 2016, is one of 16 with no phase, and was the 20th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →4 of the 29 studies in Breast Neoplasms by Institut Bergonié are open now, in 1 country. Recruiting first, the newest first:
Institut Bergonié · Sites in France
Ages 15–49
Institut Bergonié · Sites in France
Ages 18+ · Women only
Institut Bergonié · Sites in France
Ages 18+ · Women only
Institut Bergonié
Ages 18–50 · Women only
By country, each count listing its studies:
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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29 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 2
First in 1990; this study’s year is marked. 4 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 104 is above the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Median enrollment 87 across the 20 interventional studies, 149 across the 8 observational. Of the 18 that completed or were terminated, 14 (78%) have results posted.
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Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.
1 of the studies in Breast Neoplasms by Institut Bergonié that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07425548Institut BergoniéEvaluation of Quality of Life After Facial Hyaluroic Acid Injections Following Treatment for Breast Cancer. | 2027-07 |
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Among the 29 studies in Breast Neoplasms by Institut Bergonié, from their registry updates:
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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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
G1 : Motivational Intervention group
Behavioral: Motivational Intervention group
G2 : Educational advises group
Behavioral: Educational advises 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.
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 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).
Time frame: 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).
Time frame: 3 months and 6 months
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).
Time frame: 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.
Time frame: 3 months and 6 months
Number of Patients Per Current Treatments at Baseline
Time frame: Baseline
Number of Patients Per Current Treatments at 3 Months
Time frame: 3 months
Number of Patients Per Current Treatments at 6 Months
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline, 3 months, 6 months
Currently, How Many Cigarettes Per Day do You Smoke on Average?
Time frame: Baseline, 3 months and 6 months
Number of Patients Who Consume Electronic Cigarettes
Time frame: Baseline, 3 months and 6 months
Type of Consumption of Electronic Cigarettes
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 .
Time frame: 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.
Time frame: Baseline, 3 months and 6 months
Satisfaction Questionnaire
Time frame: 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.
Time frame: 3 months
| Milestone | Arm 1 | Arm 2 |
|---|---|---|
| Started | 51 | 53 |
| Completed | 39 | 46 |
| Not completed | 12 | 7 |
| Withdrew: Withdrawal by subject | 9 | 3 |
| Withdrew: Refusal to continue | 3 | 4 |
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).
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Success | 23 | 19 |
| Success not maintained | 18 | 29 |
| Missing | 7 | 5 |
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).
| participants | Arm 1 | Arm 2 |
|---|---|---|
| Success | 17 | 14 |
| Success not maintained | 1 | 1 |
| Missing | 5 | 4 |
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).
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Success | 12 | 15 |
| Failure | 22 | 26 |
| Missing | 14 | 12 |
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.
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Success | 6 | 6 |
| Failure | 2 | 2 |
| Missing | 4 | 7 |
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Surgery — Missing | 0 | 0 |
| Surgery — No | 50 | 52 |
| Surgery — Yes | 1 | 1 |
| Chemotherapy — Missing | 0 | 0 |
| Chemotherapy — No | 4 | 2 |
| Chemotherapy — Yes | 47 | 51 |
| Radiotherapy — Missing | 0 | 0 |
| Radiotherapy — No | 50 | 53 |
| Radiotherapy — Yes | 1 | 0 |
| Hormonotherapy — Missing | 0 | 0 |
| Hormonotherapy — No | 49 | 52 |
| Hormonotherapy — Yes | 2 | 1 |
| No treatment — Missing | 0 | 0 |
| No treatment — No | 51 | 52 |
| No treatment — Yes | 0 | 1 |
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Surgery — Missing | 5 | 4 |
| Surgery — No | 40 | 47 |
| Surgery — Yes | 6 | 2 |
| Chemotherapy — Missing | 5 | 4 |
| Chemotherapy — No | 32 | 40 |
| Chemotherapy — Yes | 14 | 9 |
| Radiotherapy — Missing | 5 | 4 |
| Radiotherapy — No | 36 | 30 |
| Radiotherapy — Yes | 10 | 19 |
| Hormonotherapy — Missing | 5 | 4 |
| Hormonotherapy — No | 33 | 39 |
| Hormonotherapy — Yes | 13 | 10 |
| No treatment — Missing | 5 | 4 |
| No treatment — No | 36 | 36 |
| No treatment — Yes | 10 | 13 |
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Surgery — Missing | 0 | 0 |
| Surgery — No | 49 | 53 |
| Surgery — Yes | 2 | 0 |
| Chemotherapy — Missing | 0 | 0 |
| Chemotherapy — No | 46 | 47 |
| Chemotherapy — Yes | 5 | 6 |
| Radiotherapy — Missing | 0 | 0 |
| Radiotherapy — No | 44 | 45 |
| Radiotherapy — Yes | 7 | 8 |
| Hormonotherapy — Missing | 0 | 0 |
| Hormonotherapy — No | 35 | 28 |
| Hormonotherapy — Yes | 16 | 25 |
| No treatment — Missing | 0 | 0 |
| No treatment — No | 42 | 43 |
| No treatment — Yes | 9 | 10 |
Ongoing psychotropic treatment(s) at baseline, 3 months and 6 months.
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Baseline — No | 35 | 35 |
| Baseline — Yes | 16 | 18 |
| Baseline — Missing | 0 | 0 |
| 3 months — No | 34 | 35 |
| 3 months — Yes | 12 | 14 |
| 3 months — Missing | 5 | 4 |
| 6 months — No | 29 | 30 |
| 6 months — Yes | 8 | 14 |
| 6 months — Missing | 14 | 9 |
Current monitoring with regard to behaviour/emotional state
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Baseline — Missing | 0 | 1 |
| Baseline — No | 38 | 36 |
| Baseline — Yes | 13 | 16 |
| 3 months — Missing | 5 | 4 |
| 3 months — No | 31 | 41 |
| 3 months — Yes | 15 | 8 |
| 6 months — Missing | 14 | 10 |
| 6 months — No | 29 | 37 |
| 6 months — Yes | 8 | 6 |
Type of professional followed for behaviour/emotional state at baseline
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Psychologist — No | 3 | 3 |
| Psychologist — Yes | 10 | 13 |
| Psychiatrist — No | 11 | 14 |
| Psychiatrist — Yes | 2 | 2 |
| Health professional specialising in tobaccoology and addiction — No | 13 | 15 |
| Health professional specialising in tobaccoology and addiction — Yes | 0 | 1 |
| Other professional — No | 12 | 16 |
| Other professional — Yes | 1 | 0 |
Type of professional followed for behaviour/emotional state at 3 months
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Psychologist — No | 4 | 3 |
| Psychologist — Yes | 11 | 5 |
| Psychiatrist — No | 13 | 5 |
| Psychiatrist — Yes | 2 | 3 |
| Health professional specialising in tobaccoology and addiction — No | 15 | 8 |
| Health professional specialising in tobaccoology and addiction — Yes | 0 | 0 |
| Other professional — No | 13 | 8 |
| Other professional — Yes | 2 | 0 |
Type of professional followed for behaviour/emotional state at 6 months
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Psychologist — No | 1 | 3 |
| Psychologist — Yes | 7 | 3 |
| Psychiatrist — No | 5 | 2 |
| Psychiatrist — Yes | 3 | 4 |
| Health professional specialising in tobaccoology and addiction — No | 7 | 6 |
| Health professional specialising in tobaccoology and addiction — Yes | 1 | 0 |
| Other professional — No | 8 | 6 |
| Other professional — Yes | 0 | 0 |
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.
| score on a scale | Arm 1 | Arm 2 |
|---|---|---|
| Baseline | 3.4 ± 4.2 | 2.9 ± 2.0 |
| 3 months | 3.6 ± 5.4 | 2.6 ± 1.8 |
| 6 months | 3.0 ± 4.9 | 2.7 ± 2.6 |
| Cigarettes per day | Arm 1 | Arm 2 |
|---|---|---|
| Baseline | 11.5 ± 8.1 | 10.8 ± 6.9 |
| 3 months | 9.3 ± 6.1 | 10.4 ± 7.0 |
| 6 months | 9.1 ± 6.9 | 11.0 ± 8.7 |
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Baseline — No | 25 | 24 |
| Baseline — Yes | 2 | 3 |
| 3 months — No | 17 | 16 |
| 3 months — Yes | 3 | 1 |
| 6 months — No | 15 | 12 |
| 6 months — Yes | 2 | 1 |
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Baseline — With nicotine | 1 | 3 |
| Baseline — Without nicotine | 1 | 0 |
| 3 months — With nicotine | 2 | 1 |
| 3 months — Without nicotine | 1 | 0 |
| 6 months — With nicotine | 1 | 1 |
| 6 months — Without nicotine | 1 | 0 |
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).
| score on a scale | Arm 1 | Arm 2 |
|---|---|---|
| Baseline | 3.4 ± 2.6 | 3.4 ± 2.6 |
| 3 months | 3.7 ± 2.5 | 3.8 ± 2.1 |
| 6 months | 3.0 ± 2.3 | 3.7 ± 2.7 |
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).
| score on a scale | Arm 1 | Arm 2 |
|---|---|---|
| Baseline | 7.9 ± 7.6 | 7.9 ± 6.3 |
| 3 months | 8.5 ± 7.2 | 6.3 ± 5.8 |
| 6 months | 7.9 ± 7.9 | 4.8 ± 5.2 |
Hamilton test assesses symptoms of anxiety. Its score ranges from 0 to 56. The higher the score is, the more severe the depression is.
| score on a scale | Arm 1 | Arm 2 |
|---|---|---|
| Baseline | 5.6 ± 6.1 | 5.6 ± 7.0 |
| 3 months | 4.5 ± 5.3 | 3.5 ± 4.1 |
| 6 months | 4.4 ± 6.0 | 2.6 ± 3.3 |
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.
| scores on a scale | Arm 1 | Arm 2 |
|---|---|---|
| Physical functioning | 81.0 ± 16.4 | 82.1 ± 18.1 |
| Role functioning | 84.6 ± 18.0 | 89.0 ± 17.8 |
| Emotional functioning | 67.9 ± 27.0 | 76.3 ± 20.2 |
| Cognitive functioning | 75.8 ± 27.1 | 81.6 ± 18.5 |
| Social functioning | 70.6 ± 29.9 | 78.7 ± 24.3 |
| Fatigue | 42.0 ± 26.4 | 39.0 ± 21.1 |
| Nausea and vomiting | 5.3 ± 12.6 | 3.9 ± 7.9 |
| Pain | 26.4 ± 25.3 | 28.7 ± 21.3 |
| Dyspnoea | 15.4 ± 25.9 | 27.0 ± 19.2 |
| Insomnia | 42.3 ± 32.5 | 37.6 ± 30.8 |
| Appetite loss | 14.6 ± 22.4 | 12.1 ± 18.9 |
| Constipation | 8.9 ± 18.3 | 5.7 ± 12.7 |
| Diarrhoea | 4.9 ± 11.9 | 8.0 ± 22.4 |
| Financial difficulties | 23.8 ± 32.3 | 21.3 ± 28.2 |
| Global health status/QoL | 61.1 ± 17.9 | 64.2 ± 18.4 |
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.
| scores on a scale | Arm 1 | Arm 2 |
|---|---|---|
| Physical functioning | 80.2 ± 18.5 | 86.0 ± 16.0 |
| Role functioning | 81.5 ± 24.1 | 88.2 ± 19.5 |
| Emotional functioning | 62.6 ± 28.7 | 75.6 ± 18.2 |
| Cognitive functioning | 72.5 ± 30.2 | 78.5 ± 21.8 |
| Social functioning | 70.7 ± 33.4 | 81.7 ± 27.6 |
| Fatigue | 44.1 ± 23.6 | 31.4 ± 20.5 |
| Nausea and vomiting | 7.2 ± 20.6 | 4.1 ± 12.2 |
| Pain | 27.0 ± 27.0 | 26.8 ± 25.8 |
| Dyspnoea | 17.1 ± 24.4 | 21.1 ± 27.6 |
| Insomnia | 48.6 ± 33.0 | 37.4 ± 32.7 |
| Appetite loss | 13.5 ± 24.2 | 3.3 ± 10.0 |
| Constipation | 20.7 ± 31.8 | 9.8 ± 22.7 |
| Diarrhoea | 5.4 ± 18.4 | 7.5 ± 16.0 |
| Financial difficulties | 23.1 ± 33.6 | 22.8 ± 35.3 |
| Global health status/QoL | 58.3 ± 20.7 | 63.6 ± 20.6 |
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 .
| scores on a scale | Arm 1 | Arm 2 |
|---|---|---|
| Baseline | 119 ± 11.7 | 119 ± 12.6 |
| 3 months | 114 ± 11.2 | 117.5 ± 12.5 |
| 6 months | 118 ± 13.4 | 120 ± 12.5 |
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.
| scores on a scale | Arm 1 | Arm 2 |
|---|---|---|
| Baseline | 121 ± 22.9 | 117.5 ± 32.0 |
| 3 months | 129 ± 29.0 | 126 ± 38.5 |
| 6 months | 120 ± 19.6 | 126 ± 31.7 |
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Do you think it would be important to ask cancer patients about their consumption behaviour? — Missing | 14 | 6 |
| Do you think it would be important to ask cancer patients about their consumption behaviour? — No | 1 | 2 |
| Do you think it would be important to ask cancer patients about their consumption behaviour? — Yes | 30 | 42 |
| Do you think it would be important to ask cancer patients about their consumption behaviour? — Don't know | 6 | 3 |
| Would it be useful to ask cancer patients about their alcohol/tobacco consumption behaviour — Missing | 14 | 7 |
| Would it be useful to ask cancer patients about their alcohol/tobacco consumption behaviour — No | 1 | 1 |
| Would it be useful to ask cancer patients about their alcohol/tobacco consumption behaviour — Yes | 33 | 40 |
| Would it be useful to ask cancer patients about their alcohol/tobacco consumption behaviour — Don't know | 3 | 5 |
| Would you have liked the questions on consumption to have been asked at another time? — Missing | 16 | 6 |
| Would you have liked the questions on consumption to have been asked at another time? — No | 29 | 41 |
| Would you have liked the questions on consumption to have been asked at another time? — Yes | 6 | 6 |
| Would you have liked the questions on consumption to have been asked at another time? — Don't know | 0 | 0 |
Satisfaction score ranges from 1 to 10. Low scores indicate less satisfaction.
| Participants | Arm 1 | Arm 2 |
|---|---|---|
| Missing | 15 | 6 |
| 3 | 0 | 1 |
| 5 | 3 | 5 |
| 6 | 2 | 4 |
| 7 | 0 | 3 |
| 8 | 11 | 17 |
| 9 | 8 | 6 |
| 10 | 12 | 11 |
Collected over Adverse events were not collected for this study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Groupe 1 | — | — | — |
| Groupe 2 | — | — | — |
| Age, Continuous(years) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Mean | 48.8 ± 10.4 | 48.0 ± 8.9 | 48.4 ± 9.6 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Female | 51 | 53 | 104 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Current family situation(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Single | 4 | 6 | 10 |
| In a couple | 16 | 16 | 32 |
| Married | 21 | 25 | 46 |
| Divorced | 7 | 5 | 12 |
| Widowed | 3 | 1 | 4 |
| Number of children(Child) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Mean | 1.8 ± 0.9 | 1.8 ± 1.0 | 1.8 ± 1.0 |
| Level of education(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| No diploma | 2 | 1 | 3 |
| Below high school diploma | 10 | 10 | 20 |
| High school diploma to bachelor's degree (included) | 22 | 24 | 46 |
| Higher than bachelor's degree | 17 | 18 | 35 |
| Profession(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Farmer-operators | 0 | 0 | 0 |
| Artisans, merchants and company director | 0 | 2 | 2 |
| Company's exécutives and higher intellectual profession | 11 | 16 | 27 |
| Intermediate professions | 5 | 1 | 6 |
| Employees | 21 | 25 | 46 |
| Labor | 2 | 2 | 4 |
| Pensioners | 3 | 1 | 4 |
| Economically inactive | 9 | 6 | 15 |
| Type of cancer(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Canal carcinoma in situ | 0 | 4 | 4 |
| Ductal carcinoma infiltrant | 48 | 42 | 90 |
| Other | 3 | 7 | 10 |
25 further baseline measures are reported on the registry.
Plan to share: Undecided
Ran from Mar 2016 to primary completion in Nov 2018, 32 months.
Results were first posted in May 2021, 2 years 6 months after primary completion.
Of 2,662 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 32 months is close to that.
Counting every sponsor, half of 2,772 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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