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Trial registered on ANZCTR


Registration number
ACTRN12612000516886
Ethics application status
Approved
Date submitted
4/04/2012
Date registered
15/05/2012
Date last updated
15/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
CanPrevent: An intervention to improve lifestyle factors and decrease risk of colorectal cancer
Scientific title
Development and piloting of a telephone health coaching intervention to improve lifestyle factors and reduce colorectal cancer risk in those at high risk of the disease: CanPrevent.
Secondary ID [1] 280273 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
CanPrevent
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 286222 0
Condition category
Condition code
Public Health 286439 286439 0 0
Health promotion/education
Cancer 286622 286622 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive six x one hour telephone health coaching sessions over a six week period delivered by study-trained health professionals (‘health coaches’). The health coaching sessions will focus on supporting participants to make positive lifestyle changes (physical activity, diet, weight management, alcohol and smoking) and to uptake colorectal cancer screening consistent with the Australian national guidelines.
They will also receive (i) a participant handbook including educational information on lifestyle factors and colorectal cancer screening, (ii)worksheets and(ii) a pedometer.
The worksheets will be used to track dietary intake per day and number of steps per day. The worksheets are also used as a motivational tool to record goals, motivations and barriers to leading a healthy lifestyle.
Participants are instructed to wear the pedometer daily during waking hours throughout the 6 week intervention period and to record the number of steps per day.
Intervention code [1] 284624 0
Lifestyle
Intervention code [2] 284763 0
Prevention
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286886 0
Physical Activity:Godin Leisure-Time Exercise Questionnaire
Timepoint [1] 286886 0
Baseline, 6 weeks
Primary outcome [2] 286887 0
Diet: Cancer Council New South Wales Brief Questionnaire
Timepoint [2] 286887 0
Baseline, 6 weeks
Primary outcome [3] 286888 0
Quality of Life: Short Form 36(SF-36)
Timepoint [3] 286888 0
Baseline, 6 weeks
Secondary outcome [1] 296910 0
TV viewing: Participant self-report of the average number of hours of television/dvd/video viewing in the last one week.
Timepoint [1] 296910 0
Baseline, 6 weeks
Secondary outcome [2] 296911 0
Smoking status: Assessed by using Cancer Council New South Wales brief validated questions about smoking behaviour. Participant self-reported smoking status (Current Smoker, Past Smoker or have Never Smoked). If they were a current or past smoker they were asked : age at which they first started smoking, number of smoking days per week, average number of cigarettes per day, date of when they quit smoking (if past smoker).
Timepoint [2] 296911 0
Baseline, 6 weeks
Secondary outcome [3] 296912 0
Body Mass Index(kg/m2)
Timepoint [3] 296912 0
Baseline, 6 weeks
Secondary outcome [4] 296913 0
Waist Circumference(cm)
Timepoint [4] 296913 0
Baseline, 6 weeks
Secondary outcome [5] 296914 0
Colorectal cancer (CRC) screening and perceived risk of colorectal cancer:Participants were asked whether they had ever been screened for CRC and to provide the approximate date and screening test used, they were also asked whether they intended to be screened in the future. In addition, participants were asked about their perceived risk of CRC using a modified version of brief validated
questions ["What proportion of people in the general population do you believe are diagnosed with CRC due to family history?, What do you think your chances are of ever developing CRC in your lifetime?"]
Timepoint [5] 296914 0
Baseline, 6 weeks

Eligibility
Key inclusion criteria
(i) At least one first degree relative diagnosed with colorectal cancer (ii) ability to understand and provide written informed consent in English; and (iii) have at least one poor health behaviour consistent with national recommendations [ [do not achieve >150 minutes moderate-vigorous physical activity per week; or do not adhere to a healthy diet (indicated by >4 serves red meat/week , or <2 serves fruit per day, or <5 serves vegetables per day); or consume >2 standard drinks per day; or are overweight (body mass index or BMI >25).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Persons with cognitive impairment; non-English speaking; no telephone; current or previous diagnosis of CRC; medical conditions that would limit adherence to an unsupervised lifestyle intervention.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
QLD
Recruitment postcode(s) [1] 5170 0
4305
Recruitment postcode(s) [2] 5171 0
4102
Recruitment postcode(s) [3] 5172 0
4059
Recruitment postcode(s) [4] 5173 0
4301
Recruitment postcode(s) [5] 5174 0
4010
Recruitment postcode(s) [6] 5175 0
4703
Recruitment postcode(s) [7] 5176 0
4566
Recruitment postcode(s) [8] 5177 0
4030
Recruitment postcode(s) [9] 5178 0
4006
Recruitment postcode(s) [10] 5179 0
4350
Recruitment postcode(s) [11] 5180 0
4220
Recruitment postcode(s) [12] 5181 0
4178
Recruitment postcode(s) [13] 5182 0
4717
Recruitment postcode(s) [14] 5183 0
4405
Recruitment postcode(s) [15] 5184 0
4226
Recruitment postcode(s) [16] 5185 0
4878
Recruitment postcode(s) [17] 5186 0
4870

Funding & Sponsors
Funding source category [1] 285040 0
Charities/Societies/Foundations
Name [1] 285040 0
Cancer Council Queensland
Address [1] 285040 0
553 Gregory Terrace
Fortitude Valley
QLD-4006
Country [1] 285040 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Council Queensland
Address
553 Gregory Terrace
Fortitude Valley
QLD - 4006
Country
Australia
Secondary sponsor category [1] 283902 0
None
Name [1] 283902 0
Address [1] 283902 0
Country [1] 283902 0
Other collaborator category [1] 260702 0
Individual
Name [1] 260702 0
Dr Anita Green
Address [1] 260702 0
The University of Queensland Health Service
The University of Queensland
St Lucia
QLD - 4072
Country [1] 260702 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287046 0
University of Queensland Behavioural & Social Sciences Ethical Review Committee (BSSERC)
Ethics committee address [1] 287046 0
Research & Research Training Division
Cumbrae-Stewart Building (72)
THE UNIVERSITY OF QUEENSLAND
ST LUCIA
QLD 4072
Ethics committee country [1] 287046 0
Australia
Date submitted for ethics approval [1] 287046 0
Approval date [1] 287046 0
15/12/2009
Ethics approval number [1] 287046 0
2009001723

Summary
Brief summary
CanPrevent: This study investigates the feasibility and short-term effectiveness of a lifestyle intervention for first degree relatives of colorectal cancer survivors.

Who is it for?
First degree relatives (parents, siblings, and children) of someone with a confirmed diagnosis of primary colorectal cancer (C18-C20, C218).

Intervention Details
Participants will receive six x one hour telephone health coaching sessions over a six week period delivered by study-trained health professionals (‘health coaches’). They will also receive (i) a participant handbook including educational information on lifestyle factors and colorectal cancer screening, (ii) worksheets and (ii) a pedometer.

Project Outcomes
This project will provide essential information to inform the development of a larger scale randomised controlled trial of the approach. If successful, short term study outcomes will include improved lifestyle factors and health-related quality of life potentially resulting in reduced risk of colorectal cancer, other cancers and other chronic conditions.
Trial website
Trial related presentations / publications
Presentations

Hawkes A, Patrao T, Green A, Aitken J. Short-term effectiveness and acceptability of a telephone-delivered intervention for people at risk of colorectal cancer. Clinical Oncological Society of Australia (COSA) 38th Annual Scientific Meeting. Perth, 15-17th November 2011. (poster)


Hawkes A, Patrao T, Green A, Aitken J. Short-term effectiveness and acceptability of a telephone-delivered intervention for people at risk of colorectal cancer. Australasian Society for Behavioural Health and Medicine (ASBHM) 9th Annual Scientific Conference. Melbourne, 8th-10th February 2012.
Public notes

Contacts
Principal investigator
Name 34020 0
Address 34020 0
Country 34020 0
Phone 34020 0
Fax 34020 0
Email 34020 0
Contact person for public queries
Name 17267 0
A/Prof Anna Hawkes
Address 17267 0
Cancer Council Queensland
553 Gregory Terrace
Fortitude Valley
QLD-4006
Country 17267 0
Australia
Phone 17267 0
+61 7 3634 5305
Fax 17267 0
Email 17267 0
AnnaHawkes@cancerqld.org.au
Contact person for scientific queries
Name 8195 0
A/Prof Anna Hawkes
Address 8195 0
Cancer Council Queensland
553 Gregory Terrace
Fortitude Valley
QLD-4006
Country 8195 0
Australia
Phone 8195 0
+61 7 3634 5305
Fax 8195 0
Email 8195 0
AnnaHawkes@cancerqld.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary