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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
Scientific title
Feasibility study - assessing parkrun for walking rehabilitation for people living with, and beyond, cancer: acceptability, physical function, wellness and group support
Secondary ID [1] 309496 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Cancers 329766 0
Condition category
Condition code
Cancer 326661 326661 0 0
Any cancer
Physical Medicine / Rehabilitation 326662 326662 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 325925 0
Treatment: Other
Intervention code [2] 325926 0
Rehabilitation
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.
Control group
Active

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.
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)
Primary outcome [2] 334541 0
Acceptability assessed with participant study-specific surveys, including questions on enjoyment, satisfaction and participant feedback.
Timepoint [2] 334541 0
T3 After 6 months of park run participation (intervention)
T4 At 2 month follow-up
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.
Timepoint [3] 334631 0
T3 After 6 months of park run participation (intervention)
T4 At 2 month follow-up
Secondary outcome [1] 421035 0
Quality of life, using the EORTC QLQ-30
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
Secondary outcome [2] 421036 0
Anxiety and depression, Hospital Anxiety and Depression Scale (HADS)
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
Secondary outcome [3] 421037 0
Physical activity levels, IPAQ-SF
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
Secondary outcome [4] 421038 0
Diet, Mediterranean Diet Adherence Screener (MEDAS)
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
Secondary outcome [5] 421039 0
Mood using the Daylio app
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
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.
Timepoint [6] 421040 0
T3, After 6 months of park run participation (intervention)
T4 At 2 month follow-up
Secondary outcome [7] 421463 0
Sleep using the Daylio app
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

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.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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



Intervention assignment
Crossover
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.




Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/07/2023
Actual
4/03/2024
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
21/07/2025
Actual
Sample size
Target
100
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24573 0
The Sunshine Coast Private Hospital - Buderim
Recruitment hospital [2] 24574 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment hospital [3] 24575 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 24576 0
Sunshine Coast Haematology and Oncology Clinic - Maroochydore
Recruitment hospital [5] 24577 0
University of Sunshine Coast Health Clinics - Sippy Downs
Recruitment hospital [6] 24578 0
Noosa Hospital - Noosaville
Recruitment postcode(s) [1] 40170 0
4556 - Buderim
Recruitment postcode(s) [2] 40171 0
4575 - Birtinya
Recruitment postcode(s) [3] 40172 0
4558 - Maroochydore
Recruitment postcode(s) [4] 40173 0
4556 - Sippy Downs
Recruitment postcode(s) [5] 40174 0
4566 - Noosaville

Funding & Sponsors
Funding source category [1] 313689 0
University
Name [1] 313689 0
University of the Sunshine Coast
Country [1] 313689 0
Australia
Primary sponsor type
University
Name
University of the Sunshine Coast
Address
90 Sippy Downs Drive
Sippy Downs 4556 QLD
Australia
Country
Australia
Secondary sponsor category [1] 315585 0
None
Name [1] 315585 0
Address [1] 315585 0
Country [1] 315585 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312850 0
University of the Sunshine Coast Human Research Ethics Committee
Ethics committee address [1] 312850 0
Ethics committee country [1] 312850 0
Australia
Date submitted for ethics approval [1] 312850 0
21/11/2022
Approval date [1] 312850 0
30/01/2023
Ethics approval number [1] 312850 0
A221828

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126142 0
A/Prof Suzanne Broadbent
Address 126142 0
Office T4.15 Sports Precinct
School of Health
University of the Sunshine Coast
90 Sippy Downs Drive
Sippy Downs 4556 QLD
Country 126142 0
Australia
Phone 126142 0
+61 754594545
Fax 126142 0
Email 126142 0
[email protected]
Contact person for public queries
Name 126143 0
Suzanne Broadbent
Address 126143 0
Office T4.15 Sports Precinct
School of Health
University of the Sunshine Coast
90 Sippy Downs Drive
Sippy Downs 4556 QLD
Country 126143 0
Australia
Phone 126143 0
+61 754594545
Fax 126143 0
Email 126143 0
[email protected]
Contact person for scientific queries
Name 126144 0
Suzanne Broadbent
Address 126144 0
Office T4.15 Sports Precinct
School of Health
University of the Sunshine Coast
90 Sippy Downs Drive
Sippy Downs 4556 QLD
Country 126144 0
Australia
Phone 126144 0
+61 754594545
Fax 126144 0
Email 126144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
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..
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.
Available for what types of analyses?
Data may be used for meta-analyses and audits.
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.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18943Informed consent form  [email protected] 385771-(Uploaded-20-04-2023-11-58-44)-Study-related document.docx
18944Study protocol  [email protected] 385771-(Uploaded-02-05-2023-10-43-00)-Study-related document.docx



Results publications and other study-related documents

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