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
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:
Exclusion Criteria :
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.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut Bergonié