Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000163303
Ethics application status
Approved
Date submitted
25/01/2017
Date registered
31/01/2017
Date last updated
28/11/2019
Date data sharing statement initially provided
11/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
EX-MED CANCER: A Community Based Exercise Medicine Program for Cancer Survivors
Scientific title
EX-MED CANCER: Effectiveness of a Community Based Exercise Medicine Program for Cancer Survivors
Secondary ID [1] 290661 0
Nil
Universal Trial Number (UTN)
Trial acronym
EX-MED CANCER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 301188 0
Condition category
Condition code
Cancer 300941 300941 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise Intervention:
The Ex-Med Cancer exercise intervention will involve a 3-month, group-based, supervised exercise program delivered in community fitness centres/gyms in Victoria. Prior to commencing the program, each participant will receive a consultation and individual exercise session (~60 min) with an exercise physiologists (EP) in order to individualise the exercise prescription to their specific needs according to their cancer and general health history, physical abilities and personal preferences. A combination of aerobic (e.g. walking, jogging, cycling) and resistance (i.e. lifting weights) exercise will be undertaken 3 times per week. Specifically, the aerobic exercise component will include 20 to 30 minutes of moderate to vigorous intensity cardiovascular exercise (~60-85% of estimated maximum heart rate) using a variety of modes such as walking or jogging on a treadmill, cycling or rowing on a stationary ergometer. Participants will be encouraged to undertake additional home-based aerobic exercise with the goal of achieving a total of at least 150 minutes of moderate to vigorous intensity aerobic exercise each week. The resistance exercise component will involve 6-8 exercises that target the major upper and lower body muscle groups. Intensity will be manipulated from 6-12 repetition maximum (RM; i.e. the maximal weight that can be lifted 6 to 12 times which is equivalent to ~60-85% of 1RM) using 1-4 sets per exercise. Exercise prescription will be progressive and modified according to individual response. Exercise sessions will take approximately 60 minutes and will be supervised by an experienced EP. Compliance and attendance (including the reason for any missed sessions) will be tracked throughout the program by the EP. At the completion of the 3-month supervised exercise intervention survivors will have an individual consultation with their EP (~60 min). The consultation will re-evaluate their personalised exercise prescription taking into account participants progress through the exercise sessions and develop a plan for long-term exercise behaviour.
Intervention code [1] 296540 0
Lifestyle
Intervention code [2] 296999 0
Treatment: Other
Comparator / control treatment
No comparator/control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300364 0
Participation rate of cancer survivors as determined by number of participants enrolled (plus demographic and clinical characteristics) compared with potentially eligible survivors within the catchment area.
Timepoint [1] 300364 0
Routine data capture by project staff; assessed following enrolment of the final trial participant
Secondary outcome [1] 329784 0
Adherence to Ex-Med Cancer determined by attendance rates (and reasons for non-attendance) and compliance to exercise prescription (and reasons for non-compliance)
Timepoint [1] 329784 0
Routine data capture by project staff; assessed following final participant's final exercise session
Secondary outcome [2] 329785 0
Participants lived experience of Ex-Med Cancer determined by qualitative interviews and focus groups in a subgroup of 20-30 participants
Timepoint [2] 329785 0
Within 1-2 weeks of initiating the supervised exercise sessions and post-intervention (3 months)
Secondary outcome [3] 329786 0
Health care professionals lived experience of Ex-Med Cancer determined by qualitative interviews and focus groups in a subgroup of 20-30 health care professionals
Timepoint [3] 329786 0
1 year after initiation of service implementation
Secondary outcome [4] 329787 0
Service fidelity determined by completion rates of each component within the model of care and compliance with the intended delivery of each component
Timepoint [4] 329787 0
Routine data capture by project staff; assessed following final participant's final exercise session
Secondary outcome [5] 329788 0
Safety of exercise intervention determined by the incidence and severity of adverse events (e.g. muscle pulls or strains, falls). The incidence and severity of any adverse events will be monitored and reported throughout the study by the supervising exercise physiologist. Additionally, participants will self-report incidence and severity of any adverse events using a weekly log and custom questionnaire.
Timepoint [5] 329788 0
Routine data capture by exercise physiologists and post-intervention (3 months) by participants
Secondary outcome [6] 329789 0
Physical function determined by the 6 minute walk test and the repeated chair rise test
Timepoint [6] 329789 0
At baseline (0 months) and post-intervention (3 months)
Secondary outcome [7] 329790 0
Body weight determined by validated weight scales
Timepoint [7] 329790 0
At baseline (0 months) and post-intervention (3 months)
Secondary outcome [8] 329791 0
Blood pressure determined in a resting position by validated oscillometric device
Timepoint [8] 329791 0
At baseline (0 months) and post-intervention (3 months)
Secondary outcome [9] 329792 0
Common cancer symptoms (i.e. fatigue, distress, pain, wellbeing etc.) determined by Edmonton Symptom Assessment System (ESAS)
Timepoint [9] 329792 0
At baseline (0 months), post-intervention (3 months), and follow-up (6 months)
Secondary outcome [10] 329793 0
Health-related quality of life determined by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Timepoint [10] 329793 0
At baseline (0 months), post-intervention (3 months), and follow-up (6 months)
Secondary outcome [11] 329794 0
Exercise behaviour determined by Godin Leisure-Time Exercise Questionnaire (modified to include resistance exercise)
Timepoint [11] 329794 0
At baseline (0 months), post-intervention (3 months), and follow-up (6 months)
Secondary outcome [12] 329795 0
Determinants of exercise behaviour (i.e. determinants of exercise motivation, barriers, benefits, social support, planning) determined by the Theory of Planned Behaviour Questionnaire (custom questionnaire developed in accordance with established guidelines)
Timepoint [12] 329795 0
At baseline (0 months), post-intervention (3 months), and follow-up (6 months)
Secondary outcome [13] 329796 0
Cost-effectiveness of Ex-Med Cancer determined by the ACE-Prevention methodology and involving the Client Service Receipt Inventory (CSRI) and Quality adjusted life years (QALY)
Timepoint [13] 329796 0
Routine data capture by project staff; assessed at trial completion
Secondary outcome [14] 331032 0
Participation rate of health care professionals within the cancer team as determined by the number of referrals received for Ex-Med Cancer
Timepoint [14] 331032 0
Routine data capture by project staff; assessed following final participant's final exercise session
Secondary outcome [15] 331033 0
Sustainability determined by interest from health care professionals, cancer survivors and stakeholders
Timepoint [15] 331033 0
Routine data capture by project staff; assessed following final participant's final exercise session

Eligibility
Key inclusion criteria
1) People diagnosed with any type of cancer who have completed cancer treatment (surgery, chemotherapy and/or radiotherapy) within the previous one year (Note: participants are eligible if they are currently receiving/scheduled to receive hormone therapy)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Currently receiving or scheduled to receive cancer treatment (except for hormone therapy)
2) Any medical condition that could place the participant at unreasonable risk of injury or illness caused by the exercise program
3) Performing regular exercise throughout the last 1 month defined as undertaking at least 150 mins moderate intensity aerobic exercise and two or more structured resistance exercise sessions per week (note: ‘structured’ defined as an exercise physiologist/physiotherapist/personal trainer prescribed resistance exercise program)
4) Scheduled to be away for longer than a total of 3 weeks over the next 3 months
5) Previously participated in Ex-Med Cancer
6) Unable to read and speak English and do not have an English speaking carer to assist

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/01/2018
Actual
22/01/2018
Date of last participant enrolment
Anticipated
Actual
25/02/2019
Date of last data collection
Anticipated
Actual
13/08/2019
Sample size
Target
200
Accrual to date
Final
208
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295092 0
Government body
Name [1] 295092 0
Victorian Department of Health & Human Services
Country [1] 295092 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
ACU Institute for Health and Ageing
Level 6, 215 Spring Street
Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 293911 0
Individual
Name [1] 293911 0
A/Prof Prue Cormie
Address [1] 293911 0
ACU Institute for Health and Ageing
Level 6, 215 Spring Street
Melbourne, VIC 3000
Country [1] 293911 0
Australia
Other collaborator category [1] 279345 0
Hospital
Name [1] 279345 0
Austin Health
Address [1] 279345 0
145 Studley Road
Heidelberg VIC 3084
Country [1] 279345 0
Australia
Other collaborator category [2] 279346 0
Hospital
Name [2] 279346 0
Western Health
Address [2] 279346 0
Furlong Road
St Albans VIC 3021
Country [2] 279346 0
Australia
Other collaborator category [3] 279349 0
Hospital
Name [3] 279349 0
Peter MacCallum Cancer Center
Address [3] 279349 0
305 Grattan Street
Melbourne VIC 3000
Country [3] 279349 0
Australia
Other collaborator category [4] 279350 0
Government body
Name [4] 279350 0
North Eastern Melbourne Integrated Cancer Service
Address [4] 279350 0
145 Studley Road
Heidelberg VIC 3084
Country [4] 279350 0
Australia
Other collaborator category [5] 279351 0
Government body
Name [5] 279351 0
Western & Central Melbourne Integrated Cancer Service
Address [5] 279351 0
Level 1
200 Berkeley St
Carlton VIC 3053
Country [5] 279351 0
Australia
Other collaborator category [6] 279352 0
Government body
Name [6] 279352 0
Hume Regional Integrated Cancer Service
Address [6] 279352 0
Directorate & West Hume Cancer Network
63 Wyndham St
Shepparton VIC 3630

Border East Cancer Network
Albury Wodonga Regional Cancer Centre (AWRCC)
Level 1
201-239 Borella Rd
Albury NSW 2640
Country [6] 279352 0
Australia
Other collaborator category [7] 279353 0
Government body
Name [7] 279353 0
North Western Melbourne Primary Health Network
Address [7] 279353 0
Level 1
369 Royal Parade
Parkville VIC 3052
Country [7] 279353 0
Australia
Other collaborator category [8] 279354 0
Government body
Name [8] 279354 0
Eastern Melbourne Primary Health Network
Address [8] 279354 0
18-20 Prospect Street
Box Hill VIC 3128
Country [8] 279354 0
Australia
Other collaborator category [9] 279355 0
University
Name [9] 279355 0
University of Melbourne
Address [9] 279355 0
1—100 Grattan Street
Parkville VIC 3010
Country [9] 279355 0
Australia
Other collaborator category [10] 279358 0
University
Name [10] 279358 0
Central Queensland University
Address [10] 279358 0
Bruce Highway
Rockhampton QLD 4702
Country [10] 279358 0
Australia
Other collaborator category [11] 279359 0
Charities/Societies/Foundations
Name [11] 279359 0
Cancer Council Victoria
Address [11] 279359 0
615 St Kilda Road
Melbourne VIC 3004
Country [11] 279359 0
Australia
Other collaborator category [12] 279360 0
Charities/Societies/Foundations
Name [12] 279360 0
Breast Cancer Network Australia
Address [12] 279360 0
293 Camberwell Rd
Camberwell VIC 3124
Country [12] 279360 0
Australia
Other collaborator category [13] 279361 0
Charities/Societies/Foundations
Name [13] 279361 0
Prostate Cancer Foundation of Australia
Address [13] 279361 0
Level 3
39-41 Chandos St
St Leonards NSW 2065
Country [13] 279361 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296452 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 296452 0
Ethics committee country [1] 296452 0
Australia
Date submitted for ethics approval [1] 296452 0
01/02/2017
Approval date [1] 296452 0
10/07/2017
Ethics approval number [1] 296452 0
Ethics committee name [2] 299334 0
Austin Health Human Research Ethics Committee
Ethics committee address [2] 299334 0
Ethics committee country [2] 299334 0
Australia
Date submitted for ethics approval [2] 299334 0
31/05/2017
Approval date [2] 299334 0
05/07/2017
Ethics approval number [2] 299334 0
HREC/17/Austin/236

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

Contacts
Principal investigator
Name 70870 0
A/Prof Prue Cormie
Address 70870 0
ACU Institute for Health and Ageing
Level 6, 215 Spring Street
Melbourne, VIC 3000
Country 70870 0
Australia
Phone 70870 0
+61 (0)3 9230 8242
Fax 70870 0
Email 70870 0
[email protected]
Contact person for public queries
Name 70871 0
Prue Cormie
Address 70871 0
ACU Institute for Health and Ageing
Level 6, 215 Spring Street
Melbourne, VIC 3000
Country 70871 0
Australia
Phone 70871 0
+61 (0)3 9230 8242
Fax 70871 0
Email 70871 0
[email protected]
Contact person for scientific queries
Name 70872 0
Prue Cormie
Address 70872 0
ACU Institute for Health and Ageing
Level 6, 215 Spring Street
Melbourne, VIC 3000
Country 70872 0
Australia
Phone 70872 0
+61 (0)3 9230 8242
Fax 70872 0
Email 70872 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study protocol approved through the human research ethic committee does not permit secondary analysis


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.