Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000473763
Ethics application status
Approved
Date submitted
25/04/2013
Date registered
29/04/2013
Date last updated
18/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
STRIDE (Steps TowaRd Improving Diet and Exercise): an online lifestyle intervention for cancer survivors living in South Australia
Scientific title
STRIDE (Steps TowaRd Improving Diet and Exercise): an online lifestyle intervention for cancer survivors living in South Australia
Secondary ID [1] 281869 0
Nil
Universal Trial Number (UTN)
Trial acronym
STRIDE (Steps TowaRd Improving Diet and Exercise) among cancer survivors in South Australia
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diet and exercise in cancer survivors 288251 0
Condition category
Condition code
Cancer 288604 288604 0 0
Any cancer
Diet and Nutrition 289322 289322 0 0
Other diet and nutrition disorders
Public Health 289325 289325 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention participants will take part in a 12-week lifestyle program during which they will wear a pedometer and use an online resource. The main focus of the online resource is a step log where participants enter their daily step counts, perception of exertion and feeling daily. Based on this information they will be emailed weekly step count goals. The website will also include an interactive forum that links participants to other cancer survivors. There will be a virtual notice board where community service organisers can advertise events and activities relating to physical activity and healthy eating. Information on healthy eating will be provided based on the Cancer Council Australia's nutrition guidelines which supports the recommendations in The Australian Guide to Healthy Eating (developed by the Australian Government, Department of Health and Ageing). Participants are free to use (or not use) the program at their discretion. Adherence will be monitored by number of logins to the website and follow-up telephone calls every 2 weeks during the intervention.

Health measures such as height, weight, blood pressure, waist and hip girth will be collected. Participants will also be asked to fill out questionnaires relating to their physical and psychological health.
Intervention code [1] 286431 0
Lifestyle
Comparator / control treatment
The control group will be a waitlist control. They will receive a pedometer for the first 12-weeks, and will then be given access to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 288755 0
Increased physical activity levels (increased number of steps per day) as measured by sealed pedometer readings at baseline, end-program (week 13) and three month follow-up. Step data entered by participants onto the step log during the program will also be assessed.
Timepoint [1] 288755 0
Week 13
Secondary outcome [1] 300908 0
Improved QOL outcomes. Physical and psychological wellbeing will be assessed with SF-36, self-efficacy and motivation will be assessed with the PAMA (physical activity maintenance assessment).
Timepoint [1] 300908 0
Week 13
Secondary outcome [2] 302461 0
Improved dietary habits (increased consumption of core foods and decreased consumption of non-core foods) as measured by the Cancer Council Australia's food frequency questionnaire.
Timepoint [2] 302461 0
Week 13

Eligibility
Key inclusion criteria
-Women and men with any type of cancer (except skin cancer) treated with curative intent
- Age 18 years or older
- Permanent resident of South Australia
- Not undergoing active treatment
- Access to the internet (whether it be personal access or through a library or community centre)
- Sufficient English language skills and cognitive ability to complete the questionnaires
- Approved by treating doctor to be part of the study
-Provided written informed consent
- Willingness to be randomised to intervention or waitlist control
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Evidence of metastatic disease
-Significant conditions precluding physical activity/exercise
-Special dietary plan
-Pregnancy or planning for pregnancy during the time of the study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/02/2013
Actual
10/04/2013
Date of last participant enrolment
Anticipated
Actual
10/04/2015
Date of last data collection
Anticipated
Actual
30/04/2015
Sample size
Target
82
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 286646 0
Government body
Name [1] 286646 0
Cancer Australia Supporting people with cancer Grant initiative, funded by the Australian Government
Country [1] 286646 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Frome Rd, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 285429 0
Other Collaborative groups
Name [1] 285429 0
Cancer Council Australia
Address [1] 285429 0
202 Greenhill Rd Eastwood SA 5063
Country [1] 285429 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288722 0
University of South Australia Human Ethics Committee
Ethics committee address [1] 288722 0
Frome Road, Adelaide SA 5000
Ethics committee country [1] 288722 0
Australia
Date submitted for ethics approval [1] 288722 0
Approval date [1] 288722 0
07/02/2013
Ethics approval number [1] 288722 0

Summary
Brief summary
The aim of the study is to test the effectiveness of an online resource to increase physical activity (primarily walking) and improve diet among cancer survivors living in South Australia. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have any type of cancer (except skin cancer) treated with curative intent. You need to be a permanent resident of South Australia, and you should not be undergoing any active treatment. You will also require access to the internet. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in the intervention group will take part in a 12-week lifestyle program during which they will wear a pedometer and use an online resource. The main focus of the online resource is a step log where participants enter their daily step counts, perception of exertion and feeling daily. Based on this information they will be emailed weekly step count goals. The website will also include an interactive forum that links participants to other cancer survivors. There will be a virtual notice board where community service organisers can advertise events and activities relating to physical activity and healthy eating. Information on healthy eating will be provided based on the Cancer Council Australia's nutrition guidelines which supports the recommendations in The Australian Guide to Healthy Eating (developed by the Australian Government, Department of Health and Ageing). Participants are free to use (or not use) the program at their discretion. Participants in the other group will receive a pedometer only for the first 12 weeks, after which time they will be offered the full program. Health measures such as height, weight, blood pressure, waist and hip girth will be collected from each patient at the start and end of the program, and 3 months after program completion. Participants will also be asked to fill out questionnaires relating to their physical and psychological health.
Trial website
Trial related presentations / publications
Steps toward improving diet and exercise for cancer survivors (STRIDE): a quasi-randomised controlled trial protocol
https://doi.org/10.1186/1471-2407-14-428
Public notes

Contacts
Principal investigator
Name 37490 0
A/Prof James Dollman
Address 37490 0
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 37490 0
Australia
Phone 37490 0
+61 08 8302 1413
Fax 37490 0
Email 37490 0
james.dollman@unisa.edu.au
Contact person for public queries
Name 37491 0
Dr Lauren Frensham
Address 37491 0
University of South Australia
GPO Box 2417
Adelaide SA 5001
Country 37491 0
Australia
Phone 37491 0
+61 08 8302 2680
Fax 37491 0
Email 37491 0
lauren.frensham@gmail.com
Contact person for scientific queries
Name 37492 0
Dr Lauren Frensham
Address 37492 0
University of South Australia
GPO Box 2417
Adelaide SA 5001
Country 37492 0
Australia
Phone 37492 0
+61 08 8302 2680
Fax 37492 0
Email 37492 0
lauren.frensham@gmail.com

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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