Contact information
Type
Scientific
Primary contact
Dr Elisabetta Chellini
ORCID ID
Contact details
Cancer Prevention and Research Institute
Unit of Environmental and Occupational Epidemiology
Via San Salvi
12
Florence
50135
Italy
e.chellini@ispo.toscana.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TOSC1
Study information
Scientific title
Randomised controlled trial for evaluating a brief counselling intervention on physical activity and smoking cessation to smoking women undergoing to the National Health System Cervical Cancer Screening Program (NHS-CCS-Prog) in Tuscany (Florence area), Piedmont (Turin), Emilia-Romagna (Cesena), and Lombardy (Mantua) regions
Acronym
SPRINT Study
Study hypothesis
1. To verify whether the smoking cessation counselling intervention delivered to women randomly assigned to the "smoking" intervention arm, could increase the one-year cessation rate, in comparison to that recorded in women randomly assigned to the control arm
2. To verify whether the counselling interventions on smoking cessation and physical activity delivered to women randomly assigned to the "smoking and physical activity" intervention arm, could increase the one-year cessation rate, in comparison to that recorded in women randomly assigned to the control arm, or to the "smoking" intervention arm
Ethics approval
Ethics Committee of the Local Health Authority of Florence, Italy, approved on the 5th May 2009
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Smoking cessation in adults (women)
Intervention
The smoking cessation intervention in the "smoking" and in the "smoking and physical activity" arms is tailored according to the DiClemente-Prochaska stage of change on smoking behaviour. The stage of motivational change of each participating woman is obtained from the study questionnaire that participants have to fill in while waiting for the Pap test. The counselling intervention corresponds to the first two phases of the brief intervention for smoking cessation ("Ask" and "Advice"). It takes about 2 - 3 minutes.
The physical activity intervention in the "smoking and physical activity" arm is tailored according to the DiClemente-Prochaska stage of change regarding physical activity. The stage of motivational change of each participating woman is obtained from the study questionnaire, that participants have to fill in while waiting for the Pap test. The counselling on physical activity is a brief intervention, and takes about 4 - 5 minutes.
The smoking cessation and physical activity interventions are delivered by trained midwives during the Pap-test examination, that takes about 15 - 20 minutes per attending woman.
Participating women have also to fill in an informed consent attached to the study questionnaire they have to fill in while waiting for the Pap test.
A self-help booklet on physical activity and smoking cessation is provided to all participants to the study.
A telephone follow-up of all participants is scheduled after six months and one year from the intervention, in order to evaluate how many women quit smoking after the intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Six-month smoking cessation rate
Secondary outcome measures
Stages of motivational change according to the DiClemente-Prochaska Transtheoretical Model of Change, measured before the interventions and after 6 months with a structured questionnaire delivered to participants to the study
Overall trial start date
01/09/2009
Overall trial end date
30/11/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Smoking women aged 25 - 64 years old
2. Attending the NHS-CCS-Prog Consulting Rooms located in Florence, Turin, Cesena, and Mantua areas
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1,350 smoking women
Participant exclusion criteria
1. Non-smoking and former smoking women aged 25 - 64 years old
2. Women aged less than 25 years old or more than 64
Recruitment start date
01/09/2009
Recruitment end date
30/11/2011
Locations
Countries of recruitment
Italy
Trial participating centre
Cancer Prevention and Research Institute
Florence
50135
Italy
Sponsor information
Organisation
Ministry of Health, Rome (Italy)
Sponsor details
Viale Giorgio Ribotta 5
Rome
00144
Italy
m.distefano@sanita.it
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Health, Rome (Italy) - Lombardy Region
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22950883
Publication citations
-
Results
Gorini G, Carreras G, Giordano L, Anghinoni E, Iossa A, Coppo A, Talassi F, Galavotti M, Chellini E, , The Pap smear screening as an occasion for smoking cessation and physical activity counselling: effectiveness of the SPRINT randomized controlled trial., BMC Public Health, 2012, 12, 740, doi: 10.1186/1471-2458-12-740.