Breast CancerIBMCNCT04007549
Brief Intervention for Tobacco and Alcohol Risk Reduction for Couple During Breast Cancer Treatment.
A study testing Brief motivational interview on tobacco/alcohol risk reduction in people with Breast Cancer and Smoking Cessation, run by Institut Bergonié at 1 site in France.
Trial summary
This study will examine the benefits of involving partner in a Screening, Brief Intervention and Referral to Treatment (SBIRT) program for tobacco and alcohol for women treated for breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Smoking Cessation, Alcohol Use, Unspecified
- What is being tested?
- Brief motivational interview on tobacco/alcohol risk reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2019to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- for the breast cancer patient: patients treated for a first breast cancer; Karnofsky Index> 70;
- for both patient and partner: ≥18 years old; smoking more than or equal to 1 cigarette/day;
- without ongoing treatment for current substance-related disorders; having a good understanding of the French language;
- able to express consent to benefit from intervention focused on smoking cessation;
- having an email address and internet access at home.
Who cannot join
- Refusal of the patient that his/her partner participates or refusal of the partner to participate
- Individual deprived of liberty, under guardianship or trusteeship
- Individual with a dementia or psychiatric disorder that could compromise informed consent and commitment in different times of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tobacco and Alcohol Risk Reduction for Women Treated for Breast Cancer and Partner Involvement : Benefits of a Brief Motivational Couple-based Intervention.
This study will examine the benefits of involving partner in a Screening, Brief Intervention and Referral to Treatment (SBIRT) program for tobacco and alcohol for women treated for breast cancer. Using a two-arm randomized trial (couple brief motivational intervention (CBMI) versus individual brief motivational intervention (IBMI) with repeated measures at 6 weeks, 3 and 6 months.
Read the detailed description
Background: Breast cancer is a common disease for which over 80% of women treated will still be in remission five years after diagnostic. They are a population that can benefit from support to reduce the risks associated with tobacco and alcohol consumptions. Moreover, it is well documented that health behaviors are part of a relational context. Thus, intervene on an individual level cannot suffice to apprehend health behaviors from a systemic perspective. Screening Brief Intervention and Referral to Treatment (SBIRT) program are evaluated for many years and are the reference model in health setting. However, despite national and international recommendations, SBIRT implementation in clinical routine is still very limited in oncology setting. Furthermore, intervene on multiple risk behaviors (contributing to many cancers, increasing the risk of second cancer, treatment morbidity and the risk of developing other chronic diseases) is recommended by several recent empirical studies. Involving the partner in the prevention process could help to develop healthy living environments. A SBIRT program, specifically dedicated to the oncological context and involving the partner may help to reduce tobacco and alcohol risk consumption. Methods/design: The study is a two-arm randomized trial including smoking couples. The intervention is a couple brief motivational intervention (CBMI) on tobacco/alcohol risk reduction, delivered in a single session and a booster session one month later. This intervention will be compared with an individual brief motivational intervention (IBMI) consisting a single brief motivational intervention and a booster session one month later, only delivered to the breast cancer patient; and the partner receive e-mail or postal brief advices. Measures are repeated at 6 weeks, 3 and 6 months post-intervention. The primary outcome is tobacco 7-day point prevalence abstinence (PPA) at 6 months.
- Conditions
- Breast Cancer, Smoking Cessation, Alcohol Use, Unspecified
- Being tested
- Brief motivational interview on tobacco/alcohol risk reduction
- Keywords
- Breast cancer, Smoking cessation, Alcohol risk reduction, Couple intervention, Screening, Brief intervention, Referral to treatment, Randomized Trial
- Medical subject headings
- Breast Neoplasms, Smoking Cessation, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief motivational interview on tobacco/alcohol risk reductionBehavioural
The intervention is a couple brief motivational interview (CBMI) on tobacco/alcohol risk reduction, delivered in a single session and a booster session one month later.
It is based on motivational interviewing principals (patient-centered communication, expression of empathy, develops discrepancy, deal with resistance to change, support self-efficacy and autonomy), with feedback on tobacco / alcohol consumption, information delivery and if needed referral to treatment. The intervention also specifically focuses on relational dynamics, and marital support development. This intervention will be compared with a single individual brief motivational intervention (IBMI) and a booster session one month later, only delivered to the patient; and the partner receive e-mail or postal brief advices.
All brief interventions will be carried out by the same psychologist trained and supervised for this type of intervention.
| Study group | Role | What they receive |
|---|---|---|
| Individual brief motivational intervention | Experimental | Individual brief motivational intervention (IBMI) on tobacco/alcohol risk reduction for the breast cancer patient; the partner receive e-mail or postal brief advices. Receives: Behavioral: Brief motivational interview on tobacco/alcohol risk reduction |
| Couple-based brief motivational intervention | Active comparator | Couple-based brief motivational intervention (CBMI) on tobacco/alcohol risk reduction. Receives: Behavioral: Brief motivational interview on tobacco/alcohol risk reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco 7-day point prevalence abstinence (PPA) at 6 months
Measured: 6 months
Secondary outcomes (17)
Tobacco 7-day point prevalence abstinence (PPA) at 6 months
Measured: 6 weeks
Tobacco 7-day point prevalence abstinence (PPA) at 6 months
Measured: 3 months
Quality of life as per EORTC QLQ-C30
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 - Aaronson et al. JNCI 1993
Measured: 6 months
Quality of life as per EORTC QLQ-C30
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 - Aaronson et al. JNCI 1993
Measured: 6 weeks
Quality of life as per EORTC QLQ-C30
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 - Aaronson et al. JNCI 1993
Measured: 3 months
Nicotine dependence measured using the Fageström (1978) test
Measured: 6 months
Nicotine dependence measured using the Fageström (1978) test
Measured: 6 weeks
Nicotine dependence measured using the Fageström (1978) test
Measured: 3 months
Alcohol consumption based on the AUDIT scale
Alcohol Use Disorders Test short version - Saunders JB, Aasland OG, Babor TF, de la Fuente JR and Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption II. Addiction 1993; 88:791-804.
Measured: 6 months
Alcohol consumption based on the AUDIT scale
Alcohol Use Disorders Test short version - Saunders JB, Aasland OG, Babor TF, de la Fuente JR and Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption II. Addiction 1993; 88:791-804.
Measured: 6 weeks
Alcohol consumption based on the AUDIT scale
Alcohol Use Disorders Test short version - Saunders JB, Aasland OG, Babor TF, de la Fuente JR and Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption II. Addiction 1993; 88:791-804.
Measured: 3 months
Psychological distress Symptom Checklist-90-R
SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973.
Measured: 6 months
Psychological distress Symptom Checklist-90-R
SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973.
Measured: 6 weeks
Psychological distress Symptom Checklist-90-R
SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973.
Measured: 3 months
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Measured: 6 months
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Measured: 6 weeks
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Internal organisation reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Screening, Brief Intervention and Referral to Treatment (SBIRT)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007549
- Sponsor's protocol ID
- IB 2017-05
- Other IDs
- 2017-A03315-48
- Acronym
- IBMC
- Status last verified
- Nov 2024
- First submitted
- 28 Jun 2019
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco and Alcohol Risk Reduction for Women Treated for Breast Cancer and Partner Involvement : Benefits of a Brief Motivational Couple-based Intervention.
- ClinicalTrials.gov ID
- NCT04007549
- Acronym / sponsor ID
- IBMC / IB 2017-05
- Conditions
- Breast Cancer, Smoking Cessation, Alcohol Use, Unspecified
- Keywords
- Breast cancer, Smoking cessation, Alcohol risk reduction, Couple intervention, Screening, Brief intervention, Referral to treatment, Randomized Trial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal organisation reason
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the benefits of involving partner in a Screening, Brief Intervention and Referral to Treatment (SBIRT) program for tobacco and alcohol for women treated for breast cancer. Using a two-arm randomized trial (couple brief motivational intervention (CBMI) versus individual brief motivational intervention (IBMI) with repeated measures at 6 weeks, 3 and 6 months.
Detailed description
Background: Breast cancer is a common disease for which over 80% of women treated will still be in remission five years after diagnostic. They are a population that can benefit from support to reduce the risks associated with tobacco and alcohol consumptions. Moreover, it is well documented that health behaviors are part of a relational context. Thus, intervene on an individual level cannot suffice to apprehend health behaviors from a systemic perspective. Screening Brief Intervention and Referral to Treatment (SBIRT) program are evaluated for many years and are the reference model in health setting. However, despite national and international recommendations, SBIRT implementation in clinical routine is still very limited in oncology setting. Furthermore, intervene on multiple risk behaviors (contributing to many cancers, increasing the risk of second cancer, treatment morbidity and the risk of developing other chronic diseases) is recommended by several recent empirical studies. Involving the partner in the prevention process could help to develop healthy living environments. A SBIRT program, specifically dedicated to the oncological context and involving the partner may help to reduce tobacco and alcohol risk consumption. Methods/design: The study is a two-arm randomized trial including smoking couples. The intervention is a couple brief motivational intervention (CBMI) on tobacco/alcohol risk reduction, delivered in a single session and a booster session one month later. This intervention will be compared with an individual brief motivational intervention (IBMI) consisting a single brief motivational intervention and a booster session one month later, only delivered to the breast cancer patient; and the partner receive e-mail or postal brief advices. Measures are repeated at 6 weeks, 3 and 6 months post-intervention. The primary outcome is tobacco 7-day point prevalence abstinence (PPA) at 6 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Screening, Brief Intervention and Referral to Treatment (SBIRT)
| Arm | Type | Receives |
|---|---|---|
| Individual brief motivational intervention | Experimental | Behavioral: Brief motivational interview on tobacco/alcohol risk reductionIndividual brief motivational intervention (IBMI) on tobacco/alcohol risk reduction for the breast cancer patient; the partner receive e-mail or postal brief advices. |
| Couple-based brief motivational intervention | Active comparator | Behavioral: Brief motivational interview on tobacco/alcohol risk reductionCouple-based brief motivational intervention (CBMI) on tobacco/alcohol risk reduction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- for the breast cancer patient: patients treated for a first breast cancer; Karnofsky Index> 70;
- for both patient and partner: ≥18 years old; smoking more than or equal to 1 cigarette/day;
- without ongoing treatment for current substance-related disorders; having a good understanding of the French language;
- able to express consent to benefit from intervention focused on smoking cessation;
- having an email address and internet access at home.
Key exclusion criteria (3 listed)
- Refusal of the patient that his/her partner participates or refusal of the partner to participate
- Individual deprived of liberty, under guardianship or trusteeship
- Individual with a dementia or psychiatric disorder that could compromise informed consent and commitment in different times of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief motivational interview on tobacco/alcohol risk reductionThe intervention is a couple brief motivational interview (CBMI) on tobacco/alcohol risk reduction, delivered in a single session and a booster session one month later. It is based on motivational interviewing principals (patient-centered communication, expression of empathy, develops discrepancy, deal with resistance to change, support self-efficacy and autonomy), with feedback on tobacco / alcohol consumption, information delivery and if needed referral to treatment. The intervention also specifically focuses on relational dynamics, and marital support development. This intervention will be compared with a single individual brief motivational intervention (IBMI) and a booster session one month later, only delivered to the patient; and the partner receive e-mail or postal brief advices. All brief interventions will be carried out by the same psychologist trained and supervised for this type of intervention. | Behavioural | Couple-based brief motivational intervention, Individual brief motivational intervention |
Primary outcome
Tobacco 7-day point prevalence abstinence (PPA) at 6 months
Time frame: 6 months
17 secondary outcomes
Tobacco 7-day point prevalence abstinence (PPA) at 6 months
Time frame: 6 weeks
Tobacco 7-day point prevalence abstinence (PPA) at 6 months
Time frame: 3 months
Quality of life as per EORTC QLQ-C30
Time frame: 6 months
Quality of life as per EORTC QLQ-C30
Time frame: 6 weeks
Quality of life as per EORTC QLQ-C30
Time frame: 3 months
Nicotine dependence measured using the Fageström (1978) test
Time frame: 6 months
Nicotine dependence measured using the Fageström (1978) test
Time frame: 6 weeks
Nicotine dependence measured using the Fageström (1978) test
Time frame: 3 months
Alcohol consumption based on the AUDIT scale
Time frame: 6 months
Alcohol consumption based on the AUDIT scale
Time frame: 6 weeks
Alcohol consumption based on the AUDIT scale
Time frame: 3 months
Psychological distress Symptom Checklist-90-R
Time frame: 6 months
Psychological distress Symptom Checklist-90-R
Time frame: 6 weeks
Psychological distress Symptom Checklist-90-R
Time frame: 3 months
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Time frame: 6 months
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Time frame: 6 weeks
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief motivational interview on tobacco/alcohol risk reduction in people with Breast Cancer and Smoking Cessation, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco 7-day point prevalence abstinence (PPA) at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.