Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12623000473662
Ethics application status
Approved
Date submitted
20/04/2023
Date registered
9/05/2023
Date last updated
25/04/2024
Date data sharing statement initially provided
9/05/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Assessing parkrun for walking rehabilitation for people living with, and beyond, cancer: acceptability, physical function, wellness and group support
Query!
Scientific title
Feasibility study - assessing parkrun for walking rehabilitation for people living with, and beyond, cancer: acceptability, physical function, wellness and group support
Query!
Secondary ID [1]
309496
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
None
Query!
Health condition
Health condition(s) or problem(s) studied:
Cancers
329766
0
Query!
Condition category
Condition code
Cancer
326661
326661
0
0
Query!
Any cancer
Query!
Physical Medicine / Rehabilitation
326662
326662
0
0
Query!
Other physical medicine / rehabilitation
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Regular exercise for cancer survivors is strongly recommended yet the majority of individuals do not meet the recommended levels of physical activity. Common reasons for low participation rates include access issues, poor levels of baseline fitness, fitting exercise around medical appointments and treatments, disease symptoms and treatment side effects. This study will investigate the feasibility and efficacy of the weekly walk/run community event parkrun as a means of providing exercise, social connections and mental health management for people surviving cancers.
The study has 4 data collection timepoints: T1 Baseline assessments; T2 Data collection after a 4-week control period (no intervention, normal daily activities); T3 completion of 6-month parkrun intervention; T4 2-month follow up.
Parkrun can be a walk or run event, and is self-paced and well-monitored by volunteers, therefore has the potential to be a manageable, safe mode of exercise for individuals with low functional capacity. This project will investigate the feasibility of parkrun as a mode of physical activity for cancer survivors, with regard to acceptability, enjoyment and social identification for participants, and efficacy in maintaining or improving physical and functional status, and quality of life.
This study is a 9-month prospective, cohort study, classified as a cross-over design where all participants act as their own controls and can engage in the same intervention. The study uses mixed methods. After recruitment, finalisation of informed consent procedures and screening, there will be a baseline data collection at the University of the Sunshine Coast (USC) exercise science laboratory (T1; medical history, physical assessments, surveys [including quality of life, physical activity levels, anxiety and depression, diet]) followed by 4 weeks of normal daily activities for participants (control period, no parkrun intervention). After 4 weeks (T2) all outcome measures will be assessed again at the USC laboratory prior to starting the parkrun intervention; participants will register with parkrun and then be encouraged to participate in their local parkrun walk event each Saturday morning or at their own discretion depending upon their health status. We understand that participants will have a variety of cancer types, and at different stages with varying types of treatments, and so may not be able to commit to doing weekly parkruns. After 6 months (T3), all outcome measures will be assessed again at the University laboratory and an additional paper survey of participant feedback and comments will be administered. There will be a 2-month follow-up (T4) of an additional survey (posted hard copy) seeking information on continuity of parkrun involvement, diet and exercise. The physical assessments and surveys will be administered by members of the research team who are academics and trained exercise physiologists with between 10 to 20 years experience; the dietary assessment questionnaire will be administered by a researcher who is a trained dietician of more than 10 years experience.
Project participants will be community-dwelling out-patients. They may be undergoing treatments or in remission. They will have the choice of joining in a weekly parkrun for the 6 month intervention. Parkrun events are held at Sunshine Coast parks - Mujimba, Brightwater, Baringa, Kawana, Golden Beach, Nambour, Maleny and Noosa. Parkrun attendance is automatically monitored by the parkrun organisation itself as participants scan a personal barcode prior to beginning each event; the deidentified information is registered at parkrun thus adherence can be monitored through the study. Participants do not have to complete the full 5km walk or jog and can participate in the event at their own pace, and with social or carer support if needed. Research team members will be able to attend some of the parkrun events to meet with participants although we cannot attend every event at each location. Research team connection will help with participant adherence.
Query!
Intervention code [1]
325925
0
Treatment: Other
Query!
Intervention code [2]
325926
0
Rehabilitation
Query!
Comparator / control treatment
Participants will act as their own controls, with 4 weeks of normal daily activities (usual care or management) before starting the 6-month intervention.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
334540
0
Physical function will be assessed as a composite outcome of recorded resting heart rate, oxygen saturation (recorded using a pulse oximeter), resting blood pressure (standard auscultation); walk speed and distance with the 6 Minute Walk Test (6MWT) and lower limb strength with the 30 Second Sit-to-Stand test. Participant rating of perceived effort (RPE) will be recorded during and after the 6MWT and Sit-to-Stand test. These measures will be recorded at baseline/pre-intervention T1, after 4 weeks of usual care T2 and directly post-park run intervention, T3.
Query!
Assessment method [1]
334540
0
Query!
Timepoint [1]
334540
0
T1 Baseline assessment (pre-intervention)
T2 After 4 weeks of usual care/management (control period)
T3 After 6 months of park run participation (intervention)
Query!
Primary outcome [2]
334541
0
Acceptability assessed with participant study-specific surveys, including questions on enjoyment, satisfaction and participant feedback.
Query!
Assessment method [2]
334541
0
Query!
Timepoint [2]
334541
0
T3 After 6 months of park run participation (intervention)
T4 At 2 month follow-up
Query!
Primary outcome [3]
334631
0
Adherence, assessed by the calculation of the number of park run events attended out of the total events run by the organisation during the 6-month intervention, expressed as a percentage. Further park run participation during the 2-month follow-up period will also be noted and calculated as a percentage of ongoing attendance. Event participation is recorded by parkrun when each participant's ID barcode is scanned at each event. This information can be downloaded from the organisation's database.
Query!
Assessment method [3]
334631
0
Query!
Timepoint [3]
334631
0
T3 After 6 months of park run participation (intervention)
T4 At 2 month follow-up
Query!
Secondary outcome [1]
421035
0
Quality of life, using the EORTC QLQ-30
Query!
Assessment method [1]
421035
0
Query!
Timepoint [1]
421035
0
T1, Baseline assessment (pre-intervention)
T2, After 4 weeks of usual care/management (control period)
T3, After 6 months of park run participation (intervention)
T4 At 2 month follow-up
Query!
Secondary outcome [2]
421036
0
Anxiety and depression, Hospital Anxiety and Depression Scale (HADS)
Query!
Assessment method [2]
421036
0
Query!
Timepoint [2]
421036
0
T1, Baseline assessment (pre-intervention)
T2, After 4 weeks of usual care/management (control period)
T3, After 6 months of park run participation (intervention)
T4 At 2 month follow-up
Query!
Secondary outcome [3]
421037
0
Physical activity levels, IPAQ-SF
Query!
Assessment method [3]
421037
0
Query!
Timepoint [3]
421037
0
T1, Baseline assessment (pre-intervention)
T2, After 4 weeks of usual care/management (control period)
T3, After 6 months of park run participation (intervention)
T4 At 2 month follow-up
Query!
Secondary outcome [4]
421038
0
Diet, Mediterranean Diet Adherence Screener (MEDAS)
Query!
Assessment method [4]
421038
0
Query!
Timepoint [4]
421038
0
T1, Baseline assessment (pre-intervention)
T2, After 4 weeks of usual care/management (control period)
T3, After 6 months of park run participation (intervention)
T4 At 2 month follow-up
Query!
Secondary outcome [5]
421039
0
Mood using the Daylio app
Query!
Assessment method [5]
421039
0
Query!
Timepoint [5]
421039
0
T1, Baseline assessment (pre-intervention)
T2, After 4 weeks of usual care/management (control period)
T3, After 6 months of park run participation (intervention)
T4 At 2 month follow-up
Query!
Secondary outcome [6]
421040
0
COMPOSITE SURVEY - Participation satisfaction, diet and exercise behaviour, and intent. Additional survey to collect data on satisfaction, enjoyment, project feedback, behaviour change relevant to ongoing physical activity and diet.
Query!
Assessment method [6]
421040
0
Query!
Timepoint [6]
421040
0
T3, After 6 months of park run participation (intervention)
T4 At 2 month follow-up
Query!
Secondary outcome [7]
421463
0
Sleep using the Daylio app
Query!
Assessment method [7]
421463
0
Query!
Timepoint [7]
421463
0
T1, Baseline assessment (pre-intervention)
T2, After 4 weeks of usual care/management (control period)
T3, After 6 months of park run participation (intervention)
T4 At 2 month follow-up
Query!
Eligibility
Key inclusion criteria
Cancer survivors, aged 18 years or over, diagnosed with any type of cancer (e.g. breast, prostate, colorectal, blood, bone), who have medical clearance to walk and exercise, are eligible for the study. “Cancer survivor” is described as undergoing medical treatment or in remission. Participants would be classified according to the Palliative Care Outcomes Classification (PCOC); either Stage 1 (stable) or Stage 2 (unstable but not deteriorating) Participants must have given informed consent and must be registered with parkrun before start of the first walk/run event. Participants must be able to understand and communicate in English or participate with a carer/support person who can communicate in English. Finally, participants must be able to commit to the 9-month period of the study.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
90
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Cancer survivors are ineligible for this study if they are unable to walk, are classified by the PCOC as Stage 3 (deteriorating) or 4 (terminal) or are undergoing end-of-life care, and if they do not have medical clearance to at least walk or do other light exercise. Potential participants will also be excluded if they have a serious medical condition such as uncontrolled cardiac disease (e.g. angina, arrythmias, heart failure) and/or hypertension; serious pulmonary disease where forced vital capacity (FVC1) is less than 1 litre; uncontrolled metabolic or renal disease; a current musculoskeletal injury that might cause pain during walking or jogging; a neurological condition that is a falls or exercise risk for participants; severe visual, and/or auditory impairment, or behavioural, cognitive or psychological disorder, that would affect understanding and complying with clear instructions or communicating with others. Patients are ineligible for the study if they cannot communicate in, or understand, English or follow verbal instructions from parkrun volunteers and/or a carer/support person who can speak English.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable. This is not a RCT.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Not applicable.
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Numerical data from demographic, physical and scored questionnaire outcome measures will be analysed using Excel spreadsheets, IBM©SPSS version 29 and R studio. Qualitative data (mood, participant feedback survey responses, participants' attitudes towards the intervention, enjoyment, appropriateness, suitability, convenience and perceived effectiveness of the intervention) will be analysed thematically using NVivo and following the process of Braun and Clarke (2006). Comments will be read, organised and coded using an iterative framework (familiarisation; generation of initial codes; search for themes; review of themes; definition of themes and a final report). The codes will be reviewed, discussed and refined with the coding framework drawn from the data as well as being informed by the survey questions and themes highlighted in wider literature on parkrun outcomes.
Participant demographic and cancer-related variables will be summarised using descriptive statistics (e.g. count or percent; mean and standard deviation). Linear mixed effect models will be used to determine the effect of parkrun participation on the proportion of participants meeting minimal PA recommendations. These models will include a random intercept for each participant, to account for the clustering of observation on each individual (i.e. measurements at baseline, 4-weeks usual activities, following 6 months of parkrun participation, and 2-month follow-up). A histogram and quantile-quantile plot of the model residuals will be used to determine whether the assumption of normally distributed errors is met. Model fit will be assessed using the adjusted R2 value and the model residual standard error; the most parsimonious model will be selected for inferences. Effect sizes (Cohen’s d) will be calculated where there are significant effects of time using the pooled standard deviation as the denominator.
In the case of participant attrition from the study, or if participants miss parkrun events in the 6-month intervention period, researchers will follow up with each participant individually, either through the study or at the end of the study. Reasons for reduced attendance or attrition can be gained from the participant and this information is valuable for informing the researchers of potential barriers or issues with parkrun as a mode of cancer rehabilitation exercise.
Sample size was determined via simulation methods using a random intercept model with the R package. We were interested in powering the study to detect changes in exercise adherence (measured as the proportion of cancer patients meeting minimum physical activity guidelines) and used this outcome variable in simulations. Data used to create the model were informed by previous studies (Galvao et al., 2015; Craike et al., 2016). We assumed the average proportion of cancer patients meeting minimal physical activity guidelines for aerobic exercise was 30%. Time (three levels- baseline, 6-months parkrun and follow-up), body mass index (BMI) and sex (two levels- male and female) were included as fixed factors within the sample size model. A random intercept was included for each individual participant. BMI and sex were included as fixed factors as these variables can influence exercise adherence in cancer patients. Calculations were made assuming fixed effects of 6%, 30% and 5% for sex, time and BMI respectively, and a standard deviation of the random intercept of 2%. Based on these assumptions and a type I error rate of 5%, 80 participants give approximately 80% power to detect the specific time effect of 30% increase in the proportion of participants meeting physical activity recommendations. A minimum of 100 participants will be recruited, which even allowing for potential attrition of 20 participants would still provide a minimum sample size of 80.
REFERENCES
Braun, V., and Clarke, V. Using thematic analysis in psychology. Qual Res in Psych 2006;3(2):77–101 https://doi. org/10.1191/14780 88706 qp063oa
Galvao, D.A., Newton, R., Gardiner, R., et al. Compliance to exercise-oncology guidelines in prostate cancer survivors and associations with psychological distress, unmet supportive care needs, and quality of life. Psychooncology 2015;24(10):1241-1249
Craike, M., Gaskin, C., Courneya, K., et al. Predictors of adherence to a 12-week exercise program among men treated for prostate cancer: ENGAGE study. Cancer Medicine 2016;5(5):787-794.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
31/07/2023
Query!
Actual
4/03/2024
Query!
Date of last participant enrolment
Anticipated
30/09/2024
Query!
Actual
Query!
Date of last data collection
Anticipated
21/07/2025
Query!
Actual
Query!
Sample size
Target
100
Query!
Accrual to date
1
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
24573
0
The Sunshine Coast Private Hospital - Buderim
Query!
Recruitment hospital [2]
24574
0
Sunshine Coast University Private Hospital - Birtinya
Query!
Recruitment hospital [3]
24575
0
Sunshine Coast University Hospital - Birtinya
Query!
Recruitment hospital [4]
24576
0
Sunshine Coast Haematology and Oncology Clinic - Maroochydore
Query!
Recruitment hospital [5]
24577
0
University of Sunshine Coast Health Clinics - Sippy Downs
Query!
Recruitment hospital [6]
24578
0
Noosa Hospital - Noosaville
Query!
Recruitment postcode(s) [1]
40170
0
4556 - Buderim
Query!
Recruitment postcode(s) [2]
40171
0
4575 - Birtinya
Query!
Recruitment postcode(s) [3]
40172
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [4]
40173
0
4556 - Sippy Downs
Query!
Recruitment postcode(s) [5]
40174
0
4566 - Noosaville
Query!
Funding & Sponsors
Funding source category [1]
313689
0
University
Query!
Name [1]
313689
0
University of the Sunshine Coast
Query!
Address [1]
313689
0
90 Sippy Downs Drive
Sippy Downs 4556 QLD
Australia
Query!
Country [1]
313689
0
Australia
Query!
Primary sponsor type
University
Query!
Name
University of the Sunshine Coast
Query!
Address
90 Sippy Downs Drive
Sippy Downs 4556 QLD
Australia
Query!
Country
Australia
Query!
Secondary sponsor category [1]
315585
0
None
Query!
Name [1]
315585
0
Query!
Address [1]
315585
0
Query!
Country [1]
315585
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
312850
0
University of the Sunshine Coast Human Research Ethics Committee
Query!
Ethics committee address [1]
312850
0
Research - Innovation Centre
University of the Sunshine Coast
90 Sippy Downs Drive
Sippy Downs 4556 QLD
Australia
Query!
Ethics committee country [1]
312850
0
Australia
Query!
Date submitted for ethics approval [1]
312850
0
21/11/2022
Query!
Approval date [1]
312850
0
30/01/2023
Query!
Ethics approval number [1]
312850
0
A221828
Query!
Summary
Brief summary
The purpose of this study is to determine if parkrun is an acceptable and enjoyable type of physical activity for cancer survivors or those currently with cancer.
Who is it for?
You may be eligible for this study if you are an adult who has survived any type of cancer, or if you are currently undergoing treatment for any type of cancer.
Study Details
All participants in this study will complete a 4 week review period to monitor activity levels, before registering with parkrun and being encouraged to join in their local parkrun walk event each Saturday morning, or at their own discretion depending upon their health status, for 6 months. Physical function will be measured before and after the intervention.
Participants will then be asked to complete questionnaires to determine whether parkrun is an acceptable and enjoyable physical activity, and to assess impact on physical and mental health.
It is hoped that the study may provide much-needed evidence that parkrun is accessible, inclusive, supportive, safe and effective, and that it can provide real benefits for patients that can be translated into clinical practice.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
This project is a feasibility study or pilot trial to investigate whether consistent participation in parkrun walk/jog events is an enjoyable and effective mode of physical activity for cancer survivors. The project is open to survivors of any type of cancer, whether undergoing treatment or in remission, provided volunteers have medical clearance to walk, and that they meet the inclusion criteria.
Query!
Contacts
Principal investigator
Name
126142
0
A/Prof Suzanne Broadbent
Query!
Address
126142
0
Office T4.15 Sports Precinct
School of Health
University of the Sunshine Coast
90 Sippy Downs Drive
Sippy Downs 4556 QLD
Query!
Country
126142
0
Australia
Query!
Phone
126142
0
+61 754594545
Query!
Fax
126142
0
Query!
Email
126142
0
[email protected]
Query!
Contact person for public queries
Name
126143
0
A/Prof Suzanne Broadbent
Query!
Address
126143
0
Office T4.15 Sports Precinct
School of Health
University of the Sunshine Coast
90 Sippy Downs Drive
Sippy Downs 4556 QLD
Query!
Country
126143
0
Australia
Query!
Phone
126143
0
+61 754594545
Query!
Fax
126143
0
Query!
Email
126143
0
[email protected]
Query!
Contact person for scientific queries
Name
126144
0
A/Prof Suzanne Broadbent
Query!
Address
126144
0
Office T4.15 Sports Precinct
School of Health
University of the Sunshine Coast
90 Sippy Downs Drive
Sippy Downs 4556 QLD
Query!
Country
126144
0
Australia
Query!
Phone
126144
0
+61 754594545
Query!
Fax
126144
0
Query!
Email
126144
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Unidentifiable data for demographics, physical function, QoL, anxiety and depression scores, IPAQ-SF, MEDAS, mood, adherence and qualitative responses will be made available.
Query!
When will data be available (start and end dates)?
Data will be available at the completion of the study and for 5 years after completion..
Query!
Available to whom?
De-identified data and analysis codes can be made available to researchers upon request to the research team. De-identified data and codes can also be lodged with appropriate external repositories upon request.
Query!
Available for what types of analyses?
Data may be used for meta-analyses and audits.
Query!
How or where can data be obtained?
De-identified data and analysis codes can be made available to other appropriate researchers by emailing the lead researcher at
[email protected]
. Data may also be lodged with external repositories.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
18943
Informed consent form
[email protected]
385771-(Uploaded-20-04-2023-11-58-44)-Study-related document.docx
18944
Study protocol
[email protected]
385771-(Uploaded-02-05-2023-10-43-00)-Study-related document.docx
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.
Download to PDF