Condition category
Mental and Behavioural Disorders
Date applied
24/09/2018
Date assigned
29/03/2019
Last edited
05/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Smoking rates remain high in Ireland despite considerable progress being made to reduce them in recent years. Ireland ranks second highest for smoking-related causes of death in the EU. Lung cancer, which is strongly linked to smoking, is now the most common cause of death for women in Ireland particularly those living in more disadvantaged areas. Due to this, the Irish Cancer Society developed a new stop smoking programme for women in 2012 called ‘We Can Quit’ (WCQ) which was established following a review of the literature conducted by members of our research team. We also undertook a small study to look at initial stop smoking rates from WCQ when it was first set up. There is now a need to conduct a bigger study to research this programme. This current research proposal is for a pilot of ‘We Can Quit 2’ (WCQ2).
We will now conduct a study comparing WCQ2 with the existing stop smoking services ‘usual care’ provided by the Health Service Executive (HSE) in Ireland.

Who can participate?
Adult women who are daily smokers and have an interest in quitting

What does the study involve?
One district in each pair will provide WCQ2 and the other usual care. Women who agree to take part will be asked to attend according to their district. WCQ2 is a group programme and will be delivered by community workers (Community Facilitators) trained in helping people to stop smoking. The HSE service will be delivered by trained Stop Smoking Officers and women will receive one-to-one help. Women will be asked to fill in a questionnaire at the start and end of the programme and then at 6 months after the start of the programmes. They may also be asked to take part in an interview just after they finish the programme. At the same time as the study is taking place we will look at the activities (processes) to make sure the programme is of high quality. At the end of the study we will look to see how the results can be used and if we need to do a bigger study involving more districts and more women.

What are the possible benefits and risks of participating?
The possible benefit of participating is that women may succeed in stopping smoking, which means they can expect that breathing may get better as well as ability to exercise. They can expect to have more money, better skin and hair and a lower risk of heart disease, stroke and cancer. They will also help researchers and healthcare staff to learn how to best support women to quit smoking.
There are no major risks to taking part in this study. However, some women may experience withdrawal symptoms, such as cravings to smoke, or minor side effects from nicotine replacement therapy. These will be dealt with by the Community Facilitator, Stop Smoking Officer or pharmacist.

Where is the study run from?
Trinity College Dublin (Ireland)

When is the study starting and how long is it expected to run for?
June 2017 to April 2020

Who is funding the study?
Health Research Board Ireland (Ireland)

Who is the main contact?
Professor Catherine Hayes
hayesc9@tcd.ie

Trial website

www.tcd.ie/medicine/wcq2

Contact information

Type

Scientific

Primary contact

Prof Catherine Hayes

ORCID ID

http://orcid.org/0000-0002-1576-4623

Contact details

Trinity College Dublin
Institute of Population Health
Public Health and Primary Care
Russell Centre
Tallaght Cross
Tallaght
0024
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DIFA-2017-048

Study information

Scientific title

We Can Quit2 (WCQ2): A community-based intervention on smoking cessation for women living in disadvantaged areas of Ireland: study protocol for a pilot cluster randomised controlled trial

Acronym

WCQ2

Study hypothesis

To assess the feasibility of running a definitive randomised trial to determine whether a community- smoking cessation intervention tailored to disadvantaged women affects smoking cessation rates.

Ethics approval

University of Dublin, Trinity College School of Medicine Research Ethics Committee, 03/05/2017, reference number 20170404

Study design

Interventional pragmatic two-arm single-centre parallel-group cluster randomised pilot feasibility study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

https://www.tcd.ie/medicine/iph/projects/register/index.php/

Condition

Smoking cessation

Intervention

Four matched pairs of districts (eight clusters), will be randomised with each matched pair of clusters randomised to intervention or controls in a 1:1 allocation ratio. The randomisation will follow a pragmatic approach whereby paired districts ready for the intervention will be randomised first, followed by the next available matched pair; this accounts for temporal changes over time and will provide a balanced design.
The randomisation will be conducted remotely by the Wellcome Trust Clinical Research Facility (CRF) independent of the Trial Management Team, who will have developed a Standard Operating Procedure (SOP) for this process. The code for each matched pair of districts will have been concealed and securely stored by the Wellcome-CRF. It will be revealed to the WCQ2 trial team once sufficient numbers have been recruited (or by agreement with the Trial Management Group (TMG)) if recruitment is insufficient prior to intervention delivery). Practitioners will be informed of their allocation by the research team and and participants will be informed of their allocation by the practitioners.
Participants randomised to the intervention will receive 12 weekly behavioural support group sessions and Nicotine Replacement Therapy (NRT). The group sessions are designed to enhance positive social support systems among peers. NRT is made available without cost to all intervention participants.
Each programme will be delivered in a local community facility by two trained Community Facilitators (CFs) who tend to be ex-smokers themselves. Each session will last approximately 90 minutes. The CF’s will make proactive personal contact both during and between sessions with participants using their own language and cultural style and provide opportunity to share testimonials and personal experiences. They also carry out regular Carbon Monoxide (CO) monitoring.
Participants will be followed up at end of programme (12 weeks) and at 6/12. Salivary cotinine +-anabasine to biochemically validate self-reported smoking cessation will be recorded at week 12 and at 6/12.
Participants randomised to the control arm will receive a standard face-to-face smoking cessation programme offered by the national health service in Ireland to men and women (Health Service Executive – HSE) delivered by a Smoking Cessation Officer [21]. This service model is not available in all areas but was chosen as it offers a face to face service rather than simply telephone or online support, and monitoring data were readily available.
This programme encompasses, on average, six to seven individual sessions offered in a primary care centre or hospital outpatient clinic. Sessions vary in duration and mode of delivery, however, the first of these is delivered face-to face (average session length between 30 - 45 minutes). Subsequent visits occur weekly or every two weeks and may be conducted by telephone.
Similar to WCQ the components of the behavioural support elements of the HSE programme include, reinforcing motivation to quit and setting a quit date, building a repertoire of client coping strategies, providing information on the nature of tobacco addiction and withdrawal, undertaking regular carbon monoxide checks and giving feedback on progress, planning ongoing coping mechanisms and support. Clients are informed about Nicotine Replacement Therapy and other smoking cessation pharmacotherapies. HSE clients will obtain these free of charge if they are eligible for General Medical Services (GMS).
Participants will be followed up at 12 weeks and at 6/12. Salivary cotinine +-anabasine to biochemically validate self-reported smoking cessation will be recorded at week 12 and at 6/12.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Feasibility of recruitment, assessed by the number of women enrolled in the study as a proportion of the recruitment target of 194 women from eight randomised districts within 18 months during four 12 week periods

Secondary outcome measures

1. Retention and data completion rates in each trial arm at 12 weeks and 6 months post quit date as a follow-up timepoint in the full trial. Retention will be measured as the number of women retained in the study by 12 weeks and six months post quit date as a proportion of the number of women enrolled.
Data completion will be measured as the proportion of valid sets of outcome measures completed by women at 12 weeks and six months post quit date.
2. Proportion of participants who are continuously abstinent from smoking (as per Russell Standard), at 12 weeks. This will be measured by self-report corroborated by salivary cotinine and anabasine.
3. Proportion of participants who are continuously abstinent from smoking, at 6 months after their quit date, corroborated by salivary cotinine and anabasine.
4. Proportion of enrolled smokers who engage with smoking cessation services in each trial arm (engagement is defined as arrival for a first with a smoking cessation adviser and having set a quit date). This will be measured by the proportion of women who have set a quit date up to and including the second session with a smoking cessation advisor as a proportion of those who enrolled in the study
5. Proportion of participants who report improvement in health status measured at baseline (week 1) and 12 weeks and 6 months. This will be measured by calculating the number and percentage of responses for each item of the 12-item short-form health survey (SF-12) at week 1, week 12 and 6 months. Means, standard deviations (or their non-parametric alternative) will be estimated together with the corresponding change scores and effect sizes.
6. Fidelity to and adaptation of the intervention as established by Community Facilitator checklist and diary assessed at time of focus group interview at week 12.
7. Acceptability of trial processes by participants and practitioners involved in service delivery as established by interviews at week 12.
8. Assessment of the trial design across a range of pre-designed measures PRECIS 2 during intervention delivery and at the end of the intervention and ADePT (A process for Decision-making after Pilot and feasibility Trials) decision aid will be used at the end of the intervention to aid the decision-making process around progression to the full trial.

Overall trial start date

08/06/2017

Overall trial end date

09/04/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Female
2. Aged 18 or over
3. English speaker
4. Self-reported as a daily smoker with an interest in quitting
5. Deemed to live/work within easy travel distance of the trial catchment areas
Women taking Nicotine Replacement Therapy (NRT) or who are have been prescribed bupropion/varenicline by the doctor at time of recruitment are eligible to take part, as are women using e-cigarettes.

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

The total target is 194 women (97 per arm. Recruitment of 24-25 women in each of the eight districts is required.

Participant exclusion criteria

1. Pregnant or planning a pregnancy in the near future
2. Enrolled in another smoking cessation study
3. Cannot travel to location of programme delivery
4. Do not have the capacity to give informed consent

Recruitment start date

18/01/2018

Recruitment end date

06/02/2019

Locations

Countries of recruitment

Ireland

Trial participating centre

University of Dublin Trinity College Dublin
Institute of Population Health, Public Health and Primary Care, Russell Centre, Tallaght Cross,
Tallaght
0024
Ireland

Sponsor information

Organisation

Trinity Research & Innovation, Trinity College Dublin

Sponsor details

O’Reilly Institute
Trinity College Dublin 2
Dublin
002
Ireland
+353 896 3989
Research.Office@tcd.ie

Sponsor type

University/education

Website

https://www.tcd.ie/innovation/contact/

Funders

Funder type

Government

Funder name

Health Research Board

Alternative name(s)

HRB

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Ireland

Results and Publications

Publication and dissemination plan

We intend to disseminate our findings via the following publications:
1. Study Protocol for WCQ2 pilot feasibility study in October 2018
2. Systematic review protocol for community smoking cessation trials in low income women in December 2018
3. What works to recruit women to trials - Methodology for Recruitment to WCQ2 pilot feasibility study in March 2019
4. Systematic review protocol for community smoking cessation trials in low income women in May 2019
5. Overall Findings from WCQ2 pilot feasibility study in November 2019
6. Process evaluation of WCQ2 pilot feasibility study in December 2019
7. Using the Consolidated Framework for Implementation Research (CIFR) to address barriers and facilitators to participation in the WCQ2 trial in March 2020
8. Protocol for full randomised controlled trial in March 2020
9. Policy brief in November 2019

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to explicit participant consent not being obtained for this.

Intention to publish date

30/11/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/04/2019: Internal review.