N/A
Completed N=104
Effectiveness of Screening and Brief Interventions for Alcohol and Tobacco During Breast Cancer Treatment (ONKODETOX)
Breast Cancer · Psychology, Social
Source: ClinicalTrials.gov NCT03371732 ↗
Enrolled (actual)
104
Serious AEs
—
Results posted
May 2021
Primary outcomePrimary: Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months — 23; 19; 18; 29 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months |
23; 19; 18; 29; 7; 5 | — |
| PRIMARY Number of Patients With Individual Decrease of Tobacco Consumption at 3 Months and Maintained at 6 Months |
17; 14; 1; 1; 5; 4 | — |
| SECONDARY Number of Patients With Individual Decreased of Alcohol and/or Tobacco Consumption |
12; 15; 22; 26; 14; 12 | — |
| SECONDARY Number of Patients With Decreased Alcohol and/or Tobacco Consumption |
6; 6; 2; 2; 4; 7 | — |
| SECONDARY Number of Patients Per Current Treatments at Baseline |
0; 0; 50; 52; 1; 1 | — |
| SECONDARY Number of Patients Per Current Treatments at 3 Months |
5; 4; 40; 47; 6; 2 | — |
| SECONDARY Number of Patients Per Current Treatments at 6 Months |
0; 0; 49; 53; 2; 0 | — |
| SECONDARY Number of Patients Who Continued Psychotropic Treatment(s) at Baseline, 3 Months and 6 Months |
35; 35; 16; 18; 0; 0 | — |
| SECONDARY Number of Patients Who Has Current Monitoring With Regard to Behaviour/Emotional State |
0; 1; 38; 36; 13; 16 | — |
| SECONDARY Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at Baseline |
3; 3; 10; 13; 11; 14 | — |
| SECONDARY Number of Patients Who by Type of Professional Monitored for Behaviour/Emotional State at 3 Months |
4; 3; 11; 5; 13; 5 | — |
| SECONDARY Number of Patients by Type of Professional Monitored for Behaviour/Emotional State at 6 Months |
1; 3; 7; 3; 5; 2 | — |
| SECONDARY AUDIT Score at Baseline, 3 Months, and 6 Months |
3.4; 2.9; 3.6; 2.6; 3.0; 2.7 | — |
| SECONDARY Currently, How Many Cigarettes Per Day do You Smoke on Average? |
11.5; 10.8; 9.3; 10.4; 9.1; 11.0 | — |
| SECONDARY Number of Patients Who Consume Electronic Cigarettes |
25; 24; 2; 3; 17; 16 | — |
| SECONDARY Type of Consumption of Electronic Cigarettes |
1; 3; 1; 0; 2; 1 | — |
| SECONDARY Fagerström Score |
3.4; 3.4; 3.7; 3.8; 3.0; 3.7 | — |
| SECONDARY MADRS Score |
7.9; 7.9; 8.5; 6.3; 7.9; 4.8 | — |
| SECONDARY Score of Hamilton |
5.6; 5.6; 4.5; 3.5; 4.4; 2.6 | — |
| SECONDARY Standardised Quality of Life Scores (EORTC - QLQ-C30) |
80.2; 86.0; 81.5; 88.2; 62.6; 75.6 | — |
| SECONDARY HEIQ Score |
119; 119; 114; 117.5; 118; 120 | — |
| SECONDARY Motivation Score to Change Consumption Habits (Alcohol/Tobacco) |
121; 117.5; 129; 126; 120; 126 | — |
| SECONDARY Satisfaction Questionnaire |
14; 6; 1; 2; 30; 42 | — |
| SECONDARY 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? |
15; 6; 0; 1; 3; 5 | — |
Eligibility Criteria
Inclusion Criteria
- women with primary breast cancer, without ongoing support for substance use.
- An AUDIT-C score >1 or more than one cigarette smoked per day.
- Individuals able to consent to benefit of intervention focused on substance use. (Karnofsky Index >70).
Exclusion Criteria
- Patients who currently use substances for which a second-line care is already committed.
- Patients with a Karnofsky index <70.
Data sourced from ClinicalTrials.gov (NCT03371732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.