Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Nuevo Amanecer is the peer support program. Participants receive the peer support program as soon as possible after randomization.

Waits six months, and at the end of the six months is offered the option of participating in the peer support program.

* Work with a trained counselor who is a breast cancer survivor
* Meet 8 times in-person over the 8 week program with the counselor
* Counselor helps participant develop a personalized support program to help her improve her quality of life
* Receives information on breast cancer, its treatments, and stress management

Peer Support Program

Steven Gregorich, PhD

The purpose of this study is to test whether a new program Nuevo Amanecer (A New Dawn), improves the quality of life of Latinas diagnosed with breast cancer. Trained Latina counselors who have had breast cancer provide support to recently diagnosed women. The investigators call these counselors peer support counselors.

This study will assess the effectiveness of a cognitive-behavioral stress management (CBSM) intervention for newly diagnosed Latina breast cancer patients. In our prior work, the investigators established the appropriate content of the intervention, the need for early intervention, and the value of culturally competent peer support. In this study the investigators will adapt an evidence-based CBSM intervention designed to meet these needs. This study will use a randomized controlled trial (RCT) design with a wait-listed usual care control group to adapt the intervention and test its effectiveness in improving breast cancer specific quality-of-life, and decreasing anxiety and breast cancer specific distress. The new, adapted intervention will be called "Nuevo Amanecer" (A New Dawn).

Nuevo Amanecer: Promoting the Psychosocial Health of Latinas

FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.

Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: physical well-being subscale. Of 7 items, 1 was dropped because it was conceptually different from other items on that scale. Modified subscale was scored by summing items. Possible score ranges for physical well-being were 0-24. Higher scores indicated greater well-being.

FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.

Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: social/family well-being subscale. Of 7 items, 2 were dropped because the items were conditional on having a partner (resulting in lots of missing data). Modified subscale was scored by summing items. Possible score ranges for social/family well-being were 0-20. Higher scores indicated greater well-being.

FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.

Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: emotional well-being subscale. Of 6 items, 1 was dropped because of low item-scale correlations and it was conceptually different from the other items on that scale (only positively worded item on the scale). Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0-20. Higher scores indicated greater well-being.

FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.

Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: breast cancer concerns subscale. Of 7 items, 2 were dropped because of low item-scale correlations and were conceptually different from the other items on that scale. Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0-28. Higher scores indicated greater well-being.

FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.

Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: functional well-being subscale. Of 7 items, 3 were dropped because items were conceptually different and did not converge psychometrically with the other items on that scale; the remaining 4 items were specific to enjoyment of life, thus we renamed the subscale to "Enjoyment of Life". Modified subscale was scored by summing items. Possible score ranges for enjoyment of life were 0-16. Higher scores indicated greater well-being.

FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.

Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to each of the FACT-B subscale. The total overall score is based on the sum of modified subscales (see above primary outcomes for modifications to subscales). Possible score ranges for the total overall score were 0-108. Higher scores indicated greater well-being.

BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for anxiety were 0-4. Higher scores indicated more distress.

BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for depression were 0-4. Higher scores indicated more distress.

BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for somatization were 0-4. Higher scores indicated more distress.

Breast cancer-specific distress was measured with the 7 item Intrusive Thoughts Scale (anchored to the breast cancer experience), a subscale of the revised Impact of Event Scale (RIES). Response options were 0=not at all, 1=rarely, 2=sometimes, and 3=often. Using the published scoring algorithm, items were summed after recoding responses to 0, 1, 3, and 5. Possible score ranges were 0-35. Higher scores indicate greater distress.

California Breast Cancer Research Program

Circulo de Vida Cancer Support and Resource Center

University of California, San Francisco

Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.

Peer Support Program:

* Work with a trained counselor who is a breast cancer survivor
* Meet 8 times in-person over the 8 week program with the counselor
* Counselor helps participant develop a personalized support program to help her improve her quality of life
* Receives information on breast cancer, its treatments, stress management, and cognitive refraining.

Nuevo Amanecer Peer Support Program

Wait-list Control

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Less than 6th grade

6th grade to less than high school

High school graduate

Educational attainment

Any private

Public insurance only

None

Missing data

Health insurance

Ductal Carcinoma In Situ (DCIS)

Invasive

Breast cancer

0 (in situ)

I (1)

II (2)

III (3)

Stage 0-Carcinoma in situ;

Stage I, Stage II, and Stage III-Higher numbers indicate more extensive disease: Larger tumor size and/or spread of the cancer beyond the organ in which it first developed to nearby lymph nodes and/or tissues or organs adjacent to the location of the primary tumor

Stage

Breast conserving

Mastectomy

Surgery

Both chemotherapy and radiation

Only radiation

Only chemotherapy

No treatment

Adjuvant treatment

Dr. Anna Maria Napoles

Baseline

6 month

Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.

Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

Anxiety a Subscale of the Brief Symptom Inventory (BSI)

Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)

Depression a Subscale of the Brief Symptom Inventory (BSI)

Somatization a Subscale of the Brief Symptom Inventory (BSI)

Breast Cancer-Specific Distress of the Intrusive Thoughts Scale

Baseline Assessment

3 Month Assessment

6 Month Assessment

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infertility

Genital Diseases

Urogenital Diseases

300 patients (15-25 years) from 5 different hospitals (University Hospitals of Nancy, Strasbourg, Reims, Besançon, Dijon (France)) who have finished all cancer treatments for at least 2 years.

Patients will be surveyed through self-administered questionnaires and semidirected interviews with a psychologist

Questionnaire

Christophe Roux

Patricia Fauque

Ludovic Mansuy, MD

Beatrice Delepine

Marius Teletin

Background: When a cancer is diagnosed in a child, the urgency is to take therapeutic actions. Children and their families face the reality of cancer and the reality of the treatments that, in addition to be overwhelming, might cause infertility. Immediately after the diagnosis, a fertility preservation consultation is proposed to discuss fertility preservation options. In practice, it is often difficult to organize.

Several years after the end of treatments, a second information consultation is proposed to inform about fertility, evaluate the fertility status and propose a second line of Fertility Preservation when possible. The literature reflects a lack of knowledge regarding the degree of fertility-related distress among pediatric cancer patients as well as insufficient tools at the disposal of medical doctors and nurses to discuss about reproduction with children and young adolescents.

Project objective: Understand how young cancer patients and their parents felt about sterility risk at the diagnostic time and now as cured adolescents.

Patients \& Methods:

300 patients (15-25 years) from 5 different centers (20 patients per year and per center for 3 years) will be included in this study at the information consultation. They will be surveyed through self-administered questionnaires and semidirected interviews that will 1) retrieve perceptions and emotional being of children during the fertility preservation consultation; 2) assess the decision-making process of parents and family since the fertility preservation consultation through the patient's speech; 3) interview the patients about personal history and experience of cancer and consequences of potential fertility impairment and 4) survey the current experience and projections in the future and evaluate their reaction to the proposition of a second line of Fertility Preservation.

Expected results: what points should the doctor / psychologist discuss with pediatric cancer survivors in response to their fertility stress? and how to do it? for better initial and follow-up care to improve their quality of life after cancer.

Fertility and Temporality in Pediatric Oncology

Patients will report the outcomes of the infertility risks on the questionnaire provided in this study.

Positive and negative impacts will be questioned.

Using the factors that facilitate or hinder referral to fertility preservation to create a tool for clinicians designed to increase the referral for fertility preservation of children and adolescents with cancer

National Cancer Institute, France

Central Hospital, Nancy, France

Principal Investigator

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.

Motivational Intervention group

Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.

Educational advises group

Marion BARRAULT-COUCHOURON, PhD

Despite scientific, clinical and political incentives, alcohol and/or tobacco screening and brief intervention (SBI) services are poorly implemented in oncology settings. Motivational brief interventions are recognized as particularly effective in changing health behaviors, especially consumption behaviors. The motivational approach is more and more used in primary care setting but still few studies explore its effectiveness with breast cancer patients.

This study aims to compare two intervention arms : educational advices intervention (EAI) versus brief motivational intervention (BMI) for alcohol and/or tobacco consumption in breast cancer women, during their treatment.

In this pilot prospective randomized trial, various psychological and behavioral, variables are measured (alcohol and tobacco consumption, distress, anxiety and depressive disorders, quality of life, motivation for change, empowerment) before the brief intervention, and after 3 and 6 month.

Context :

It is now well documented that alcohol and tobacco reduce the effectiveness of a treatment, increase the side effects, favor the recurrence and/or secondary cancers and affects the quality of life of patients treated for cancer, including breast cancer. The announcement of the disease could create a window of opportunity for change in lifestyle for patients. The 2014-2019 French Cancer Plan emphasizes the need for the implementation of prevention and risk reduction related to alcohol and tobacco. A screening, brief motivational and referral to treatment program, specifically dedicated to oncology can be public health approach aiming to reduce the harmful consequences of substance misuse and improving the prognosis and quality of life of consumers at risk.

Main objective :

Evaluate effectiveness of a brief motivational intervention for alcohol and/or tobacco in short (3 month) and medium (6 month) terms in breast cancer patients, in a prospective randomized pilot study.

Secondary objectives :

* Determine the behavioral and psychopathological specific characteristics of the patient linked to change process and maintain.
* Define a brief intervention for alcohol/tobacco consumption model adapted and integrated to patient treated for cancer according to psychosocial factors highlighted.

The investigators will seek to highlight the benefit of a motivational brief intervention versus standardized educational advice. The specificity of these interventions is to be integrated in an interview integrating a systematic screening of the emotional distress of the patient, of these concerns as well as of his perceived need for aids.

Method :

This is a randomized clinical trial comparing two interventions. The trial includes 200 primary breast cancer patients with a positive AUDIT-C score and/or are tobacco consumers, randomly placed in two groups :

G1 : Motivational Intervention group (N = 100) : Participants in the intervention group benefit a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.

G2 : Educational advises group (N = 100) : Participants in this group benefit of brief educational advises (10 minutes interview maximum), and received a pamphlet on the health effects of alcohol and tobacco consumption. For obvious ethical reasons, the investigators selected an intervention in the form of advice concerning the effects of the product and the submission of specific documentation (criteria not retained in the context of the brief intervention model). It did not seem possible to evaluate patients without offering them the possibility of a low threshold intervention.

Detailed scripts for each modality of intervention are realized.

Measurement :

Three sets of measurements are taken at baseline, 3-month and 6 month follow-up.

Primary Outcome measures: Clinically significant reduction (beneficial to health) of risk behaviours (alcohol and/or tobacco consumption) :

* Concerning subjects with only alcohol consumption at baseline : The intervention will be considered effective at 3 months if an individual decrease of 20% in the AUDIT score is observed at 3 months compared to the value collected at baseline; The intervention will be considered effective at 6 months if this 20% reduction is maintained at 6 months, still in relation to the value collected at baseline.
* The same applies to subjects with only tobacco consumption at baseline: The intervention will be considered effective at 3 months if an individual decrease of 20% in the number of cigarettes consumed per day is observed at 3 months compared to the value collected at baseline; The intervention will be judged effective at 6 months if this 20% reduction is maintained at 6 months, still in relation to the value collected at baseline.
* Finally, with regard to women with both alcohol and tobacco use at baseline :

The intervention will be considered effective if at least one of the two scores (AUDIT or number of cigarettes consumed per day) has decreased by 20% at 3 months (maintained at 6 months) compared to the value collected at baseline, with no increase in the other score.

Secondary outcome measures :

* Individual reduction of around 20% in average daily consumption of alcohol and/or tobacco (calculated on the basis of patients' consumption schedules) between inclusion and the first follow-up at 3 months, and maintenance of this success at the second follow-up at 6 months (with no increase in other consumption if the subject has both alcohol and tobacco consumption at inclusion);
* Description of the variables relating to the consumption of alcohol, tobacco, the current medico-psychological situation, psychological distress, anxio-depressive symptomatology, willingness to change alcohol and/or tobacco consumption habits;
* Improved quality of life in the experimental intervention arm compared to the standard intervention arm

Study procedure :

SCREENING-PRE-INCLUSION: Screening of distress and alcohol/tobacco consumptions is realized when the patients arrive in the oncology department for their chemotherapy treatment, by a research assistant-psychologist. Researchers propose to eligible patients to participate to the study. This first contact permits to check the absence of non-inclusion criteria; to ensure the informed consent of the person (an information and consent note will be given to him) and according to these elements, to define the provisional timetable for participation in the research.

T0 - INCLUSION AND RANDOMIZATION The research assistant retrieves the signed consent, ensuring a time available to return if necessary and carries out the research interview/assessment. The randomization is realized following this interview.

INTERVENTION: Brief intervention (G1 : Brief motivational intervention or G2 : educational advices) are conducted by the research assistant-psychologist, at the Institut Bergonié or by telephone if needed.

T1: MONITORING - FOLLOW-UP(3 months) Assessments are repeated, when the patient comes at the Institut Bergonié, by telephone if necessary.

T2: MONITORING - FOLLOW-UP (6 months) Assessments are repeated, when the patient comes at the Institut Bergonié, by telephone if necessary.

Randomization procedure :

The randomization procedure is done via the TENALEA server, managed by the Epidemiological and Clinical Research Unit (UREC) of the Bergonié Institute.

Expected results :

Highlighting:

* The efficacy of motivational brief intervention on alcohol and tobacco consumption in patients treated for breast cancer ; versus educational advices intervention.
* Psychosocial risk factors involved in maintaining problematic consumption or in the rapid relapse of tobacco/alcohol consumption.

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

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

Individual decrease of 20% in the AUDIT (Alcohol Use Disorders Identification Test) score observed at 3 months

AUDIT test measures alcohol consumption and makes it possible to describe its profiles. Its score ranges from 0 (no consumption) to 28 (alcohol dependence).

Individual decrease of 20% in the AUDIT score observed at 3 months compared to the value collected at baseline and maintained at 6 months.

Success depends on tobacco consumption at 3 months and 6 months.

AUDIT test measures alcohol consumption and makes it possible to describe its profiles. Its score ranges from 0 to 28. Its score ranges from 0 (no consumption) to 28 (alcohol dependence).

Individual reduction of around 20% in the average daily consumption of alcohol and/or tobacco (calculated on the basis of consumption schedules) between inclusion and the first follow-up at 3 months (with no increase in the other consumption if the subject has both alcohol and tobacco consumption at inclusion).

Individual reduction of around 20% in the average daily consumption of alcohol and/or tobacco (calculated on the basis of consumption schedules) between inclusion and the first follow-up at 3 months and a continuation of this reduction at the second follow-up at 6 months (with no increase in the other consumption if the subject has both alcohol and tobacco consumption at inclusion).

Success depends on alcohol and tobacco level consumption at 3 months and 6 months.

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

Current monitoring with regard to behaviour/emotional state

Type of professional followed for behaviour/emotional state at baseline

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

Type of professional followed for behaviour/emotional state at 6 months

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

Higher scores indicate a worse outcome: alcohol dependence.

Fagerström test assesses tobacco consumption and makes it possible to describe patterns of tobacco addiction. Its score ranges from 0 (non-addiction to smoking) to 10 (strong or very strong dependence on tobacco).

MADRS (Montgomery-Åsberg Depression Rating Scale) assesses the severity of depression in patients with mood disorders. Its score ranges from 0 (normothymic) to 60 (depression).

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

QLQ-C30 questionnaire (EORTC) assesses quality of life across 15 dimensions :

* 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning;
* 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties;
* 1 global health dimension: Global health status/QoL

Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.

HEIQ (Health Education Impact Questionnaire) assesses the concept of empowerment (health-promoting behaviours, commitment, social integration, etc.). Its scores range from 0 to 160. Higher scores mean a better health-related empowerment .

This score ranges from 0 to 140.

The questionnaire consists of 14 questions on motivation to change alcohol/tobacco consumption habits, each with a response scale ranging from 0 (probably not) to 10 (probably).

For each question, a sub-score ranges from 0 to 10 is given and then a total score of motivation to change consumption habits is calculated by adding up all the answers to the 14 items.

The higher the score is, greater the patient's willingness to change his or her alcohol/tobacco consumption.

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

Ligue contre le cancer, France

Institut Bergonié

Adverse events were not collected for this study.

G1 : Motivational Intervention group

Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.

Groupe 1

G2 : Educational advises group

Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.

Groupe 2

Arm 1: Motivational Intervention group

Motivational Intervention group: Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.

Arm 1

Arm 2 : Educational advises group

Educational advises group: Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.

Arm 2

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Current family situation

Number of children

Level of education

Profession

Type of cancer

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

Tumor extension stage

Chemotherapy

Radiotherapy

Hormonotherapy

Without treatment

Past treatment(s)

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

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

Spouse's AUDIT-C score

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

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

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

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

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

Alcohol

Tobacco

Cannabis

Other

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

Depressive disorders

Bipolar and related disorders

Anxiety disorders

OCD and related

Disorders related to trauma or stressors

Substance-related or Addictive

DSM5 - Whole Life

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

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

DSM5 - Current Life - Substance-related or addictive disorders

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

Electronic cigarettes

Among electronic cigarette smokers only (N=5)

Type of consumption of electronic cigarettes

Ongoing psychotropic treatment(s)

Psychologist

Psychiatrist

Health professional specialising in tobaccoology and addiction

Other professional

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

Type of professional

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

AUDIT Score (patient)

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

Score Audit categorical variable (Patient)

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

Fagerström score

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

MADRS Score (Quantitative variable)

MADRS Score (Categorical variable)

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

Score of Hamilton

HEIQ (Health Education Impact Questionnaire) assesses the concept of empowerment (health-promoting behaviours, commitment, social integration, etc.).

Its scores range from 0 to 160. Higher scores mean a better health-related empowerment .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nuevo Amanecer: Promoting the Psychosocial Health of Latinas	NCT01383174	Breast Neoplasm... Psychology, Soc...	Peer Support Pr...	18 Years -	University of California, San Francisco
Fertility and Temporality in Pediatric Oncology	NCT05048771	Fertility Issue... Childhood Cance... Psychology, Soc...	Questionnaire	15 Years - 25 Years	Central Hospital, Nancy, France
Effectiveness of Screening and Brief Interventions for Alcohol and Tobacco During Breast Cancer Treatment (ONKODETOX)	NCT03371732	Breast Cancer Psychology, Soc...	Motivational In... Educational adv...	18 Years -	Institut Bergonié
Nuevo Amanecer II: Translating a Stress Management Program for Latinas	NCT02931552	Breast Neoplasm... Psychology, Soc...	Nuevo Amancer-I...	18 Years -	University of California, San Francisco

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