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Trial registered on ANZCTR


Registration number
ACTRN12621000154808
Ethics application status
Approved
Date submitted
16/11/2020
Date registered
15/02/2021
Date last updated
15/02/2021
Date data sharing statement initially provided
15/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Care to Quit: An intervention for people with cancer who smoke
Scientific title
The Care to Quit stepped wedge randomised trial on the effect of a best-practice cessation care intervention in cancer centres for people with cancer who smoke
Secondary ID [1] 302408 0
Nil known
Universal Trial Number (UTN)
U1111-1256-3036
Trial acronym
C2Q
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco smoking 319205 0
Cancer 319206 0
Condition category
Condition code
Cancer 317174 317174 0 0
Any cancer
Public Health 317175 317175 0 0
Health service research
Public Health 317176 317176 0 0
Other public health
Public Health 318002 318002 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Care to Quit Intervention
‘Ask, Advise, Act/Help’ (as per state-based recommendations)
All patients who smoke tobacco or have recently quit and who are receiving anti-cancer therapies at the study centres will be eligible to receive cessation care from clinic staff. The ‘Ask Advise Help’ model is consistent with National Comprehensive Cancer Network recommendations for evidence-based cessation support for cancer patients:

Ask: Assess and record smoking status (current smoker or recent quitter);
Advise: Give a personalised description of the specific benefits of smoking abstinence during and after treatment; endorse use of evidence-based support (telephone counselling and pharmacotherapy);
Act/Help: Offer referral to Quitline or other local cessation support service (including education around the benefits of Quitline); prescribe, provide or advise on pharmacotherapy options (nicotine replacement therapy (NRT) or varenicline) which are safe during treatment; and monitor progress. The above components of the cessation care model are the staff behaviours that our implementation intervention (described below) aims to target. A description of how these will be measured is provided in secondary outcomes (provision of smoking cessation care).

The model is relevant for current smokers and people who have recently quit smoking, including access to NRT for as a relapse prevention strategy. As people with cancer are likely to report abstinence when in fact they are still smoking it is important to ensure all recent quitters have evidence-based forms of cessation support ready at hand. The roles of oncologists, physicians, nurses, radiation therapists, hospital pharmacists and other relevant staff in the delivery of ‘Ask Advise Help’ will be tailored by the site staff to reflect the local context as part of the intervention process. Pre-existing skills, expertise and experience relevant to provision of smoking cessation care will differ across staff.

Implementation of Care to Quit
Intervention Phase: Implementation
The implementation intervention has been developed following the Theoretical Domains Framework (TDF). The TDF is a validated comprehensive framework for identifying barriers and enablers to behaviour change and includes 14 theoretical domains. We used this framework in preliminary work that included patient surveys, staff surveys, a pilot study and consensus processes, and prior unpublished work (Sherwood, Tzelepis, Day & Paul et al, unpublished). The strategies also address the need to adapt intervention content to the contexts being encountered. Further detail is provided in a separate manuscript (Tait et al, unpublished) describing intervention development using the TDF and APEASE criteria (affordability, practicability, effectiveness and cost effectiveness, acceptability, side effects/safety and equity).

The overall duration of intervention implementation for the cessation care model is 12 months.
Stage 1 (3 months): Building staff capability and motivation and identifying champions
Small group and individual outreach visits with oncologists, physicians and lead cancer nurses will be delivered by a behavioural scientist with smoking cessation expertise, and ideally a clinician e.g. oncologist and a Quitline counsellor. At least one small group visit (30 minutes) and one individual visit per person identified by research team and sites as integral to implementation (e.g. head of department, senior staff member; one hour) will be conducted across Stage 1.
The trainers’ specific backgrounds and expertise will be reported in the trial outcome paper. The visits will be interactive, use behavioural principles and incorporate the use of brief persuasive videos from discipline-relevant opinion leaders.

The visits will address: i) the evidence of cessation benefits specific to the types of patients the oncologist sees; ii) evidence for multi-session specialist telephone support (i.e. Quitline) including how counselling is now tailored to support people with cancer; iii) evidence regarding cessation pharmacotherapy during cancer treatment; iv) suggested scripts and modelling of brief interactions for succinctly discussing cessation benefits and endorsing Quitline; v) sensitive timing and framing of stop smoking messages and vi) reviewing recent consultations and managing challenging cases.

Stage 2 (9 months): Identifying and implementing cessation care models/pathways
During stage 1 an inter-disciplinary team interested in championing smoking cessation care will be identified and invited to form an interprofessional, multi-disciplinary team of project champions at each cancer centre. The team will be supported by regular teleconferences with the researchers to identify how to implement ‘Ask Advise Help’ within existing patient pathways. Researchers will work collaboratively with sites to develop within each site.

Sites will be supported (for the duration of Stage 2) with a suite of evidence-based implementation strategies tailored to the needs of the individual site. Implementation strategies include: i) feedback of current rates of care using data collected in the baseline phase, ii) evidence-informed training for staff not involved in stage 1 (delivered via multiple formats such as face to face and existing online Quit and health departmental training, with refreshers and updates at regular intervals), and iii) educational tools for use with patients. The method of providing pharmacotherapy will vary as not all centres are able to provide this directly to outpatients. Where the medication cannot be supplied directly to the patient (e.g. using a hospital pharmacist-led or nurse-led approach), a prescription can be written by the treating doctor. Referral to the patient’s GP for prescription of pharmacotherapy may also occur. Ongoing support will be provided to sites to support adherence to the collaborative and tailored models developed.

Staff will be invited to complete surveys online (or print if preferred by the site) at each study phase (baseline, intervention, post-intervention) to collect process measures data, experiences with and perceptions of the Care to Quit intervention and provision of smoking cessation care. Due to the stepped-wedge design of the trial, sites will enter intervention and follow-up periods at varying timepoints. Sites 1-3 will enter intervention at 6 months post baseline, sites 4-6 at 13 months post baseline and sites 7-9 at 19 months post baseline. Staff surveys will therefore occur at varying timepoints from baseline across sites. The intervention period questionnaires will be completed mid-intervention period (i.e. 6 months post beginning of intervention period) for each cluster of sites (i.e. 13 months post baseline for sites 1-3, 19 months post baseline for sites 4-6 and 25 months post baseline for sites 7-9). The post-intervention period questionnaires will be completed at the beginning of the post-intervention period (19 months post baseline for sites 1-3, 25 months post baseline for sites 4-6 and 28 months post baseline for sites 7-9).

As the support provided at Stage 1 and 2 will be delivered following assessment of site need (including current procedures, existing staff skills and experience) and tailored accordingly, further details of intervention dose (i.e. consultations, meetings, training materials provided) and mode of delivery (e.g., individual vs group, powerpoint presentations, videos) will be provided in the trial outcome paper. Project records will be used to document staff attendance at meetings and training. The delivery of smoking cessation support to patients will be implemented as part of routine care and tailored to site. Therefore, this may occur individually face to face at outpatient clinics, via telephone and/or telehealth and the amount or ‘dose’ of the support will differ.
Intervention code [1] 318694 0
Behaviour
Intervention code [2] 318695 0
Treatment: Drugs
Intervention code [3] 319298 0
Lifestyle
Comparator / control treatment
Standard smoking care
During the baseline phase each site will continue current care as usual. Standard care will differ at each site depending on their current usual practice. This may include screening some patients for smoking status at some time points and offering interventions such as referral to Quitline. Usual practice may also differ by clinicians within sites.

Control group
Active

Outcomes
Primary outcome [1] 325251 0
Prolonged abstinence
The primary outcome is defined as self-reported 6-month prolonged abstinence (with no relapse i.e. 7+ days of prolonged smoking) at the 7 month follow-up, allowing participants up to 1 month to stop smoking. This will be measured at the 7 months post baseline computer assisted telephone interview (CATI).
Timepoint [1] 325251 0
7 months post baseline (allowing participants up to 1 month to stop).
Secondary outcome [1] 387342 0
Biochemically verified abstinence from smoking (for participants reporting prolonged abstinence at the 7-month follow-up, and no smoking in the last week). Measured via breath carbon monoxide monitor or salivary cotinine test.
Timepoint [1] 387342 0
7 months post baseline.
Secondary outcome [2] 387343 0
Length of quit attempts (defined as stopping smoking for a period of 24 hours or more) as assessed by CATI.
Timepoint [2] 387343 0
7 months post baseline CATI.
Secondary outcome [3] 387344 0
Nicotine dependence: assessed using the two item Heaviness of Smoking Index (HSI) It uses a six-point scale calculated from the number of cigarettes smoked per day (1–10, 11–20, 21–30, 31+) and the time to first cigarette after waking (<5, 6–30, 31–60, and 61+ min). Nicotine dependence is then categorized into a three-category variable: low (0–1), medium (2–4), and high (5–6).
Timepoint [3] 387344 0
Baseline, 7 months post baseline.
Secondary outcome [4] 387345 0
Daily consumption: Cigarettes per day (CPD) as measured by item 1 of the HIS; “How many cigarettes do you typically smoke per day?” HSI and CPD are strong predictors of quitting behaviour.
Timepoint [4] 387345 0
Baseline, 7 months post baseline.
Secondary outcome [5] 387346 0
Mental Health and Quality of Life as measured by the Functional Assessment of Cancer Therapy-General rapid version (FACT-G7). FACT-G7 is a 7 item measure for evaluating symptom/concern burden and quality of life in advanced cancer patients over time.
Timepoint [5] 387346 0
Baseline, 7 months post baseline.
Secondary outcome [6] 387347 0
Provision of smoking cessation care
Advice to quit: as measured by any indication of a personalised description of the specific benefits of smoking abstinence during and after cancer treatment or endorsed use of evidence-based support (telephone counselling and pharmacotherapy), extracted by medical record audit and patient self-report.
Timepoint [6] 387347 0
Baseline, 7 months post baseline.
Secondary outcome [7] 387348 0
Provision of smoking cessation care
Proactive referral to Quitline (including education around the benefits of Quitline): as assessed by review of Quitline records, medical record audit and patient self-report.
Timepoint [7] 387348 0
Baseline, 7 months post baseline.
Secondary outcome [8] 387349 0
Provision of smoking cessation care
Prescription or provision of pharmacotherapy (including NRT and stop smoking medications) as assessed by medical record audit and patient self-report.
Timepoint [8] 387349 0
Baseline, 7 months post baseline.
Secondary outcome [9] 388825 0
Cost effectiveness
Cost effectiveness will be measured by cost per successful quit attempt from a service-provider perspective. These data will be sourced from project and site records.
Timepoint [9] 388825 0
7 months post baseline
Secondary outcome [10] 388826 0
Process measure
Advice to quit: as assessed by staff self-report (study specific questionnaire) delivery of advice, patient self-report (study specific questionnaire; including the source [doctor, nurse, radiation therapist, other], and content [whether cancer-related reasons for quitting were provided] and impact of the advice).
Timepoint [10] 388826 0
Baseline, intervention (which will begin within week one of intervention commencement) and post-intervention for staff self-report questionnaire.
Baseline, 7 months post baseline for patient self-report questionnaire.
Secondary outcome [11] 388828 0
Process measure
Perceived competence with providing advice to quit: as measured by staff self-report study specific questionnaire.
Timepoint [11] 388828 0
Baseline, intervention (which will begin within week one of intervention commencement) and post-intervention for staff self-report.
Secondary outcome [12] 388829 0
Process measure
Referral to Quitline and quality of contacts: as assessed by staff and participant self-report study specific questionnaire.
Timepoint [12] 388829 0
Baseline, intervention (which will begin within week one of intervention commencement) and post-intervention for staff self-report.
Baseline, 7 months post baseline for patient self-report.
Secondary outcome [13] 388830 0
Process measure
Provision or prescription of pharmacotherapy and attitudes: as assessed by patient self-report study specific questionnaire.
Timepoint [13] 388830 0
Baseline, 7 months post baseline for patient self-report.
Secondary outcome [14] 388831 0
Process measure
Attitudes and acceptability of providing/receiving cessation support: as measured by staff self-report study specific questionnaire.

Timepoint [14] 388831 0
Baseline, intervention (which will begin within week one of intervention commencement) and post-intervention for staff self-report.
Secondary outcome [15] 388832 0
Process measure
System perspectives: including staffing, workload, leadership, technology, infrastructure, as assessed by qualitative interviews (using semi-structured interview guide) with key informants.
Timepoint [15] 388832 0
Baseline, intervention (which will begin within week one of intervention commencement) and post-intervention.
Secondary outcome [16] 388834 0
Training in providing smoking cessation care: staff will be asked about if they have received smoking cessation care training and the form of training received in a study specific staff questionnaire.

Timepoint [16] 388834 0
Baseline, intervention (which will begin within week one of intervention commencement) and post-intervention for staff self-report.
Secondary outcome [17] 388835 0
Experience and perceptions of Care to Quit intervention: as measured by staff self-report questionnaire (study-derived items).

Timepoint [17] 388835 0
Intervention (which will begin within week one of intervention commencement) and post intervention.
Secondary outcome [18] 389818 0
Process measure
Provision or prescription of pharmacotherapy and attitudes: as assessed by staff self-report study specific questionnaire.
Timepoint [18] 389818 0
Baseline, intervention (which will begin within week one of intervention commencement) and post-intervention for staff self-report.
Secondary outcome [19] 389819 0
Process measure
Attitudes and acceptability of providing/receiving cessation support: as measured by patient self-report study specific questionnaire.
Timepoint [19] 389819 0
Baseline, 7 months post baseline for patient self-report.

Eligibility
Key inclusion criteria
Patients eligible for inclusion will meet the following criteria:
(i) aged at least 18 years
(ii) diagnosed with any form of cancer in the prior six months (from date of pathology or radiology confirmation). Patients with metastatic disease are eligible, provided they have stable disease on current therapy and do not have an estimated prognosis of less than 12 months survival.
(iii) report combustible tobacco use either in the past 90 days, or in the 30 days prior to cancer diagnosis
(iv) able to understand and speak English sufficiently to provide informed consent and participate in computer assisted telephone interviews; and have appropriate support (e.g. interpreter if required and available within their cancer service) to complete the study documentation.
(v) able to give informed consent
(vi) accessing anti-cancer therapy from participating sites
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) participants will be excluded if they are using e-cigarettes only (i.e. not smoking combustible tobacco products e.g. cigarettes) in the past 90 days, or in the 30 days prior to cancer diagnosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed (due to randomisation at a hospital level). Care to Quit is a stepped wedge cluster randomised trial of an implementation intervention of best practice cessation care versus treatment as usual in nine Australian hospitals that provide care to patients with cancer. All sites (hospitals) begin as part of the control condition and are block-randomised. At each intervention ‘step’, three sites will be selected at random to commence the intervention. Centres will be randomly allocated to ‘step’ i.e. time of commencement of the intervention phase, by an independent statistician. The study design was chosen because the intervention involves the implementation of smoking cessation care as routine practice for all patients with cancer who smoke or have recently quit.
As researchers will travel to sites to provide support for implementation of the intervention, it is unlikely that study research assistants enrolling participants will remain blind to the intervention phase.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
At each intervention ‘step’, three sites will be selected at random to commence the intervention. Centres will be randomly allocated to ‘step’ i.e. time of commencement of the intervention phase, by an independent statistician. For pragmatic reasons, three sites will be treated as their own cluster due to the concern for contamination if sites participated in the intervention at different times.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
The current trial is a stepped wedge cluster randomised. In a stepped wedge design, all hospitals begin in the control condition and then move to the intervention condition at randomised intervals. During the control phase, all patients will receive ‘treatment as usual’. At randomised intervals across the study, researchers will provide sites with training and other support in the Care to Quit intervention. Following this, all patients will receive ‘intervention’.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The trial will recruit 2160 smokers (40 per site per 6 months over three years for each of nine sites). This sample size will provide approximately 80% power to detect a difference of 7% in smoking cessation (i.e. during the baseline phase 7% of those who were smokers or recent quitters at recruitment will achieve 6 months prolonged abstinence, while during the intervention phase 14% of those who are still smoking at diagnosis will achieve 6 months abstinence) at an alpha level of 0.05, assuming an intra-cluster correlation of 0.01 and a worst-case scenario of cluster autocorrelation equal to zero. This sample also provides over 90% power to detect each of the differences previously stated for the secondary outcomes.

Statistical Analyses
Independent and blinded statisticians from the CReDITSS Unit at the Hunter Medical Research Institute, Australia, supervised by CI Barker, will conduct analyses of the primary and secondary outcomes.

Logistic regression within a generalised linear mixed models framework will be used to model the primary and secondary outcome measures. All models will adjust for time using a fixed effect that describes the phase of the study (pre-intervention and each of the 3 steps). Variation between sites will be accounted for using a random effect for site and repeated measures on sites will be accounted for using a random effect for time within site. To estimate the intervention effect, a variable indicating when the intervention was active for a given site and time will be included in the models. As the timing of the 7-month CATI for some participants overlaps with intervention commencement, the analyses of 6 months abstinence will include a 6 month offset to the coding of the intervention indicator variable to allow the full effect of the intervention to be in place before estimating its effect.

Economic evaluation
Using a health services perspective, incremental cost-effectiveness ratios will be calculated from the cost per person quit in the intervention phase (i.e., self-reported, 6-month abstinence from smoking) compared to usual care in the pre-intervention phase. Costs for the delivery of the intervention (e.g. clinician training, smoking cessation resources, NRT/pharmacotherapy where appropriate) will be derived directly from trial data and added to the costs of clinician time (e.g. oncology nurses) in usual care. Exploratory, modelled analyses will examine the potential impacts of smoking cessation (intervention versus usual care) on the cost per quality adjusted life year saved, using mortality relative risk estimates derived from published studies of survival by post-diagnosis smoking cessation (however these studies are likely subject to confounding by indication for quitting and as such modelled results based on these data will be interpreted cautiously). Modelled analyses will include estimates of the health-system costs of cancer and health state utilities for cancer survivors. Sensitivity analyses will address potential variation in costs and the survival benefits due to smoking cessation.

Qualitative Evaluation
A nested qualitative study will be conducted. All interviews (key informants and Quitline counselors) will be audio recorded, transcribed, and a general inductive approach will be taken to the analysis. Interviews will be guided by semi-structured interview guides.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 17690 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 17691 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [3] 17692 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 17693 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [5] 17694 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [6] 17695 0
The Alfred - Melbourne
Recruitment hospital [7] 17696 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 17697 0
Maroondah Hospital - Ringwood East
Recruitment hospital [9] 17698 0
Yarra Ranges Health - Lilydale
Recruitment hospital [10] 18195 0
Gosford Hospital - Gosford
Recruitment hospital [11] 18196 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment postcode(s) [1] 31536 0
2298 - Waratah
Recruitment postcode(s) [2] 31537 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 31538 0
2170 - Liverpool
Recruitment postcode(s) [4] 31539 0
2560 - Campbelltown
Recruitment postcode(s) [5] 31540 0
2200 - Bankstown
Recruitment postcode(s) [6] 31541 0
3004 - Melbourne
Recruitment postcode(s) [7] 31542 0
3128 - Box Hill
Recruitment postcode(s) [8] 31543 0
3135 - Ringwood East
Recruitment postcode(s) [9] 31544 0
3140 - Lilydale
Recruitment postcode(s) [10] 32252 0
2250 - Gosford
Recruitment postcode(s) [11] 32253 0
2340 - Tamworth

Funding & Sponsors
Funding source category [1] 306830 0
Government body
Name [1] 306830 0
National Health and Medical Research Council (NHMRC)
Address [1] 306830 0
16 Marcus Clarke Street
Canberra City ACT 2600
Country [1] 306830 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 307404 0
None
Name [1] 307404 0
Address [1] 307404 0
Country [1] 307404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306993 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 306993 0
Level 3, Pod, HMRI, Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305
Ethics committee country [1] 306993 0
Australia
Date submitted for ethics approval [1] 306993 0
31/07/2020
Approval date [1] 306993 0
07/09/2020
Ethics approval number [1] 306993 0
HREC Reference Number: 2020/ETH02010

Summary
Brief summary
This study is aiming to assess the effect of a smoking cessation program called ‘Care to Quit’ on smoking behaviours in people with cancer who smoke.

Who is it for?
You may be eligible for this study if you are over 18 years of age, have been diagnosed with any form of cancer in the last 6 months, and have used combustible tobacco (e.g. cigarettes) in the past 90 days.

Study details

The proposed study employs a stepped wedge randomised trial design involving the recruitment of cancer patients across 9 centres. In a stepped wedge design, all hospitals begin in the control condition and then move to the intervention condition at randomised intervals. During the control phase, hospitals will deliver ‘treatment as usual’ smoking cessation support (which will vary depending on hospital site usual practice). The intervention involves a ‘Care to Quit’ program, which involves training health professionals in how to deliver and implement best practice smoking cessation care in their hospitals. This process will be tailored to hospital sites.

All participants will receive a number of surveys about their smoking behaviours and well-being at the beginning of the study, and 7 months later.

It is hoped that this program will improve smoking abstinence in cancer patients, and contribute to formation of guidelines that aid healthcare workings in helping cancer patients to quit smoking.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105674 0
Prof Christine Paul
Address 105674 0
Level 4 West, Hunter Medical Research Institute, John Hunter Hospital, Lot 1 Kookaburra Circuit, New Lambton Heights, Newcastle, New South Wales, 2305, Australia
Country 105674 0
Australia
Phone 105674 0
+61 2 4042 0693
Fax 105674 0
Email 105674 0
Chris.Paul@newcastle.edu.au
Contact person for public queries
Name 105675 0
Prof Christine Paul
Address 105675 0
Level 4 West, Hunter Medical Research Institute, John Hunter Hospital, Lot 1 Kookaburra Circuit, New Lambton Heights, Newcastle, New South Wales, 2305, Australia
Country 105675 0
Australia
Phone 105675 0
+61 2 4042 0693
Fax 105675 0
Email 105675 0
Chris.Paul@newcastle.edu.au
Contact person for scientific queries
Name 105676 0
Prof Christine Paul
Address 105676 0
Level 4 West, Hunter Medical Research Institute, John Hunter Hospital, Lot 1 Kookaburra Circuit, New Lambton Heights, Newcastle, New South Wales, 2305, Australia
Country 105676 0
Australia
Phone 105676 0
+61 2 4042 0693
Fax 105676 0
Email 105676 0
Chris.Paul@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results