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Brief Intervention for Tobacco and Alcohol Risk Reduction for Couple During Breast Cancer Treatment. (IBMC)

Primary Purpose

Breast Cancer, Smoking Cessation, Alcohol Use, Unspecified

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Brief motivational interview on tobacco/alcohol risk reduction
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Breast cancer, Smoking cessation, Alcohol risk reduction, Couple intervention, Screening, Brief intervention, Referral to treatment, Randomized Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Institut Bergonie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individual brief motivational intervention

Couple-based brief motivational intervention

Arm Description

Individual 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 (CBMI) on tobacco/alcohol risk reduction.

Outcomes

Primary Outcome Measures

Tobacco 7-day point prevalence abstinence (PPA) at 6 months

Secondary Outcome Measures

Tobacco 7-day point prevalence abstinence (PPA) at 6 months
Tobacco 7-day point prevalence abstinence (PPA) at 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
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
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
Nicotine dependence measured using the Fageström (1978) test
Nicotine dependence measured using the Fageström (1978) test
Nicotine dependence measured using the Fageström (1978) test
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.
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.
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.
Psychological distress Symptom Checklist-90-R
SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973.
Psychological distress Symptom Checklist-90-R
SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973.
Psychological distress Symptom Checklist-90-R
SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973.
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).

Full Information

First Posted
June 28, 2019
Last Updated
July 2, 2019
Sponsor
Institut Bergonié
Collaborators
Ligue contre le cancer, France
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1. Study Identification

Unique Protocol Identification Number
NCT04007549
Brief Title
Brief Intervention for Tobacco and Alcohol Risk Reduction for Couple During Breast Cancer Treatment.
Acronym
IBMC
Official Title
Tobacco and Alcohol Risk Reduction for Women Treated for Breast Cancer and Partner Involvement : Benefits of a Brief Motivational Couple-based Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié
Collaborators
Ligue contre le cancer, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Screening, Brief Intervention and Referral to Treatment (SBIRT)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individual brief motivational intervention
Arm Type
Experimental
Arm Description
Individual brief motivational intervention (IBMI) on tobacco/alcohol risk reduction for the breast cancer patient; the partner receive e-mail or postal brief advices.
Arm Title
Couple-based brief motivational intervention
Arm Type
Active Comparator
Arm Description
Couple-based brief motivational intervention (CBMI) on tobacco/alcohol risk reduction.
Intervention Type
Behavioral
Intervention Name(s)
Brief motivational interview on tobacco/alcohol risk reduction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tobacco 7-day point prevalence abstinence (PPA) at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Tobacco 7-day point prevalence abstinence (PPA) at 6 months
Time Frame
6 weeks
Title
Tobacco 7-day point prevalence abstinence (PPA) at 6 months
Time Frame
3 months
Title
Quality of life as per EORTC QLQ-C30
Description
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 - Aaronson et al. JNCI 1993
Time Frame
6 months
Title
Quality of life as per EORTC QLQ-C30
Description
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 - Aaronson et al. JNCI 1993
Time Frame
6 weeks
Title
Quality of life as per EORTC QLQ-C30
Description
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 - Aaronson et al. JNCI 1993
Time Frame
3 months
Title
Nicotine dependence measured using the Fageström (1978) test
Time Frame
6 months
Title
Nicotine dependence measured using the Fageström (1978) test
Time Frame
6 weeks
Title
Nicotine dependence measured using the Fageström (1978) test
Time Frame
3 months
Title
Alcohol consumption based on the AUDIT scale
Description
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.
Time Frame
6 months
Title
Alcohol consumption based on the AUDIT scale
Description
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.
Time Frame
6 weeks
Title
Alcohol consumption based on the AUDIT scale
Description
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.
Time Frame
3 months
Title
Psychological distress Symptom Checklist-90-R
Description
SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973.
Time Frame
6 months
Title
Psychological distress Symptom Checklist-90-R
Description
SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973.
Time Frame
6 weeks
Title
Psychological distress Symptom Checklist-90-R
Description
SCL-90-R, Derogatis et al. Psychopharmacol Bull. 1973.
Time Frame
3 months
Title
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Time Frame
6 months
Title
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Time Frame
6 weeks
Title
Scores of conjugal adaptability and cohesion with The Family Adaptability and Cohesion Evaluation Scale (FACE III).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion BARRAULT-COUCHOURON, PhD
Phone
+33 5.56.33.32.94
Email
m.barrault@bordeaux.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Simone MATHOULIN-PELISSIER, MD, PhD
Email
s.mathoulin@bordeaux.unicancer.fr
Facility Information:
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Brief Intervention for Tobacco and Alcohol Risk Reduction for Couple During Breast Cancer Treatment.

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