Effectiveness of Screening and Brief Interventions for Alcohol and/or Tobacco During Breast Cancer Treatment: A Phase III, Pilot Prospective Randomized Trial (ONKODETOX)
Phase: NA
Conditions: Breast Cancer, Psychology, Social
Sponsor: Institut Bergonié

 
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EFFECTIVENESS OF SCREENING AND BRIEF INTERVENTIONS FOR ALCOHOL 
AND TOBACCO DURING BREAST CANCER TREATMENT 
 
 
NCT03371732 
 
15/10/2015 
 
 
 
 
 

 
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PROTOCOL SUMMARY  
Scientific background 
It is now well-documented that alcohol and tobacco reduce the effectiveness of 
treatments, increase their side effects, seem to promote recurring and/or secondary cancers 
and have effects on the quality of life of patients treated for a cancer pathology. Breast cancer 
is a common disease for which more than 80% of patients will still be in remission 5 years 
after the disease. These women constitute a population which can greatly benefit from 
assistance concerning the adoption of beneficial behaviours for health or from assistance in 
reducing behavioural risks, particularly related to alcohol and tobacco. The 2014-2019 Cancer 
Plan emphasises the need to facilitate access to care for patients with problematic substance 
use. A programme of early intervention practices (spotting, detection, brief intervention and 
referral) focusing specifically on the oncological context can therefore be a public health 
approach aimed at reducing the harmful consequences of substance misuse and at improving 
the prognosis and quality of life of at-risk consumers. 
 
Primary objectives 
 
- Evaluate the effects of the implementation in clinical routine of a programme of 
identification, detection, and brief interventions with women treated for breast cancer, with 
high-risk consumption behaviours (alcohol and tobacco) and evaluate the effects of device 
implantation 
 
- Evaluate the effectiveness of a brief motivational intervention in the short and medium term 
compared to a basic standard counselling type intervention; 
 
Procedure 
 
Prospective randomised pilot study with control group. Inclusion of 200 patients followed for 
a first breast cancer and having a positive AUDIT-C score and/or tobacco consumption. 
 
- At the time of the medical consultation, the patient will be offered the possibility of being 
contacted for screening for psychological distress and her lifestyle concerning alcohol and 
tobacco, by a trained psychology research assistant. The patient will also give her consent to 
complete an assessment which will take place before the caregiver interview. 
 
- A certain number of psychological and behavioural variables will be informed via an online 
questionnaire: screening for alcohol and tobacco consumption, diagnoses of substance-related 
disorders, anxiety-depressive disorders, quality of life, emotional distress, consumption of 
patient's family and close friends, self-efficacy and perceived importance, empowerment, and 
motivation to change will be taken into account.  Socio-demographic, 

 
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medical and past interventions related to problematic PAS consumption will also be provided. 
 
- Interview conducted by a psychology research assistant trained in the detection of distress, 
the identification of high-risk behaviour and in brief intervention. Review of the psychoactive 
substance (PAS) consumption detection results and brief motivational intervention (G1) or 
educational advice on alcohol and tobacco (G2). 
 
Three months and 6 months (T4) after the brief intervention, the quantitative evaluation of all 
the psychological and medical variables (except for aspect 1 disorders and socio-demographic 
data) will be repeated. 
 
Anticipated results 
 
Demonstration of: 
 
- the effectiveness of brief motivational-type intervention strategies on high-risk 
consumption behaviours in patients treated for breast cancer; psychosocial risk factors 
involved in the maintenance of problematic consumption or in the rapid resumption of 
consumption behaviours. 
 
The advantage of implementing this type of procedure is on the one hand to be able to set 
up an early system of access to care, in particular by promoting the care of the most 
vulnerable groups. It also aims to promote the systematic screening of all psycho-social needs, 
including an exploration of the patient's lifestyle. This approach is intended to develop a 
culture of prevention and risk reduction during the care of women treated for breast cancer. 
Moreover, this type of programme can drive a change in the representations of caregivers in 
oncology concerning addictive behaviour. Specific training modules can then be offered.