Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000975594
Ethics application status
Approved
Date submitted
31/08/2015
Date registered
17/09/2015
Date last updated
17/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pathways to Smoking Care Implementation Project: Evaluation of smoking cessation care delivery in cancer patients and health care staff in NSW.
Scientific title
Implementing smoking cessation support for cancer patients in NSW: A feasibility study
Secondary ID [1] 287383 0
NIL
Universal Trial Number (UTN)
Trial acronym
P-SCIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 296075 0
Cancer 296124 0
Condition category
Condition code
Cancer 296338 296338 0 0
Any cancer
Public Health 296389 296389 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational only. Cross-sectional survey of cancer patients and cancer care staff.
The aim of this study is to identify the degree to which smoking cessation care delivery is provided and describe opportunities for and barriers to improving care.
Cancer patients receiving treatment in medical, radiation or surgical oncology units will be recruited. Similarly, staff providing care in these units will complete the staff survey. Allied health staff that are involved in the care of cancer patients will also be recruited.
Intervention code [1] 292732 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295991 0
Identify the degree to which smoking cessation care delivery is provided to cancer patients, assessed via descriptive statistical analysis of survey items (e.g. "Did any of your doctors or nurses ask whether you smoke tobacco?)"
Timepoint [1] 295991 0
This outcome is assessed at the time of survey.
Secondary outcome [1] 317120 0
Determine the proportion of oncology medical and nursing staff in NSW who report routinely delivering cessation advice and support to patients.
Timepoint [1] 317120 0
This outcome is assessed by items in both the staff and patient surveys specifically designed for this study (e.g. proportion of responses to items relating to actual delivery of care for staff, and actual receipt of care for patients). Outcome assessed at time of survey.
Secondary outcome [2] 317324 0
Examine the patient and system factors associated with the reported clinician delivery of smoking care to cancer patients Assessed as a composite outcome.
Timepoint [2] 317324 0
This outcome is assessed by items in both the staff and patient surveys specifically designed for this study (i.e. responses to items relating to opportunities for and barriers to improving smoking cessation care). Outcome assessed at time of survey

Eligibility
Key inclusion criteria
Patients who:
- Are over 18 years of age
- Have been diagnosed with any form of cancer in the last 12 months
- Have attended the medical, radiation or surgical oncology clinic (depending on where recruitment is occurring at each site) previously (i.e. it is not their first appointment)
-Are able to speak and read English sufficiently
-Are able to complete the survey
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who:
- Are physically or mentally incapable of completing the survey
- Are unable to provide informed consent
- Are attending the clinic for the first time
- Have completed the survey previously
- Are too unwell to complete the survey, as indicated by staff

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Descriptive statistics will be applied to the data to describe the sample. For example, proportion of responses to the staff and patient survey questions will be calculated (e.g. 50% of staff reported delivering smoking cessation care to their patients).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/05/2015
Actual
12/05/2015
Date of last participant enrolment
Anticipated
18/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4280 0
Westmead Hospital - Westmead
Recruitment hospital [2] 4281 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 4282 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [4] 4283 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [5] 4284 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [6] 4285 0
Orange Health Service - Orange
Recruitment hospital [7] 4286 0
Concord Repatriation Hospital - Concord

Funding & Sponsors
Funding source category [1] 291950 0
Government body
Name [1] 291950 0
Cancer Institute NSW
Country [1] 291950 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 290617 0
None
Name [1] 290617 0
Address [1] 290617 0
Country [1] 290617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293445 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 293445 0
Research Support and Development Office
District Headquarters, Administration Building
Lookout Road,
New Lambton NSW 2305
Ethics committee country [1] 293445 0
Australia
Date submitted for ethics approval [1] 293445 0
31/10/2014
Approval date [1] 293445 0
01/12/2014
Ethics approval number [1] 293445 0
HREC/14/HNE/457

Summary
Brief summary
The primary purpose of this study is to evaluate the current smoking cessation care provided to cancer patients in New South Wales (NSW) and identify opportunities and barriers to achieving routine clinician delivery of smoking cessation care.

Who is it for?
You may be eligible to participate in this study if you are aged 18 or over and have been diagnosed with any form of cancer in the past 12 months and attend a medical, radiation or surgical oncology clinic at one of the recruiting hospitals in NSW.

Study details
All participants in this study will complete one survey. Patients will answer a survey with questions regarding the smoking cessation care they have been offered, while staff will be asked questions regarding the smoking cessation care offer to cancer patients.
Results from the surveys will be reviewed and used to evaluate the current smoking cessation care provided, and identify opportunities for implementing routine care across NSW. It is hoped that information gained as part of this study will provide information on the current care provided to cancer patients who smoke, and provide the first step towards achieving a system-wide smoking cessation protocol for these patients.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 59958 0
A/Prof Christine Paul
Address 59958 0
University of Newcastle
School of Medicine & Public Health
University Drive
Callaghan NSW 2308
Australia
Country 59958 0
Australia
Phone 59958 0
+61 2 4042 0693
Fax 59958 0
Email 59958 0
[email protected]
Contact person for public queries
Name 59959 0
Christine Paul
Address 59959 0
University of Newcastle
School of Medicine & Public Health
University Drive
Callaghan NSW 2308
Australia
Country 59959 0
Australia
Phone 59959 0
+61 2 4042 0693
Fax 59959 0
Email 59959 0
[email protected]
Contact person for scientific queries
Name 59960 0
Christine Paul
Address 59960 0
University of Newcastle
School of Medicine & Public Health
University Drive
Callaghan NSW 2308
Australia
Country 59960 0
Australia
Phone 59960 0
+61 2 4042 0693
Fax 59960 0
Email 59960 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.