WithdrawnNot Applicable

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

Stopped: Internal organisation reason

France0Started 2019-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months

Trial details

NCT IDNCT04007549

SponsorInstitut Bergonié

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10

View on ClinicalTrials.gov More Breast Cancer trials