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Trial registered on ANZCTR


Registration number
ACTRN12620000663954
Ethics application status
Approved
Date submitted
15/05/2020
Date registered
10/06/2020
Date last updated
10/06/2020
Date data sharing statement initially provided
10/06/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
FiGHTING F!T: An exercise program for adolescents and young adults during cancer treatment in Western Australia
Scientific title
FiGHTING F!T: A randomised controlled trial determining the effect of a structured supervised exercise intervention on physical fitness during treatment for cancer in adolescents and young adults in Western Australia
Secondary ID [1] 301295 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Cancer 317476 0
Condition category
Condition code
Cancer 315579 315579 0 0
Any cancer
Physical Medicine / Rehabilitation 315715 315715 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following patients providing informed consent and consent being sought by the participants treating clinician participants will undergo a baseline assessment. This assessment is conducted by an Accredited Exercise Physiologist (AEP) and is repeated at 10 weeks and 20weeks post recruitment.
The following parameters will be collected at baseline, ten weeks and twenty weeks:
• Demographic information: diagnosis, treatment, medical history.
• Cardiopulmonary Exercise Testing (CPEX): to measure submaximal oxygen consumption (Vo2peak)
• Anthropometrics: Body mass, height, BMI, waist/hip circumference.
• Strength: 1 repetition maximum (1RM) for leg press, row and chest press strength grip strength
• Physical function: 30sec push up, sit ups, sit to stand.
• Body composition: using dual energy x-ray absorptiometry (DEXA) to measure fat mass, muscle mass and bone mineral density.

The following feasibility data will be collected and analysed throughout the study period:
• Adverse events
• Information relating to withdrawal from the study
• Adherence to the exercise intervention
• Compliance to the study protocol.

Stratification and randomisation
Following baseline assessment participants will be randomised by stratified permuted block randomisation. Patients will be stratified according to intensity of their cancer treatment; High intensity vs moderate/low intensity treatment regimen (ie treatment for Hodgkin lymphoma (moderate) vs treatment for sarcoma (high)). Participants will then be randomised to either immediate exercise or usual care (delayed exercise) groups.

Intervention
Participants randomised to the ‘immediate’ exercise intervention group will commence their exercise program the week following their baseline assessment. The exercise sessions will be conducted in a hospital based gymnasium in a one-on-one capacity. The biweekly sessions will be conducted for 10 weeks and supervised by an AEP. The baseline testing and subsequent exercise sessions will commence prior to the beginning of the second cycle of patients’ systemic treatment. The AEP will design an individual exercise program for each participant based initially on the results of the baseline functional assessment, which will then be progressed weekly as tolerated by the individual patient. Following the 10-week intervention participants, will be reassessed and then receive no intervention (usual care) for the following 10 weeks to the final assessment at 20 weeks

Control (delayed exercise)
Patients randomised to the ‘delayed’ exercise intervention group will receive “usual care”, and will not be offered the additional (experimental) exercise intervention for the initial 10 weeks following baseline assessment. See details below.

Exercise intervention
Exercise programs for all participants will be mixed mode; incorporating a combination of aerobic and resistance exercises. All programs will follow the ACSM guidelines for cancer survivors. Over the course of the program, it is expected that each participant will engage in 30 minutes of aerobic exercise and 30 minutes of resistance training within each of the two weekly supervised sessions. ACSM guidelines recommend cancer survivors complete >150 minutes of aerobic exercise per week, therefore participants will be encouraged to complete additional aerobic exercise such as walking at home to accumulate a total of 150 minutes over the week. The exercise sessions will be designed using the results of the baseline functional assessment. The aerobic exercise will be prescribed at 60-80% of Vo2peak (as determine by the CPET) and the resistance program at 50-80% of 1RM (as determine by chest press, leg press and row).
Exercise intensity will be monitored using heart rate monitors and Rating of Perceived Exertion (RPE) scales. Participants will be encouraged to exercise at a moderate to high intensity (60% to 85% heart rate max). Aerobic exercise modalities will include upright/recumbent bike cycling, treadmill walking/jogging, skipping and/or boxing. The resistance exercise will comprise of an exercise for each major muscle group, with three sets of 10-15 reps per exercise. The AEP will aim to progress exercise intensity as tolerated. Participants will also be encouraged to engage in aerobic exercise outside of supervised exercise sessions through a home based aerobic exercise prescription to be completed at independently at home. They will be asked to document their activity in exercise journals. If participants fail to attend a session they will be telephoned to determine the cause of their non-adherence. Session adherence will be recorded on a weekly basis and used for reporting at the end of the intervention.
Intervention code [1] 317602 0
Lifestyle
Intervention code [2] 317683 0
Prevention
Intervention code [3] 317684 0
Rehabilitation
Comparator / control treatment
Control (delayed exercise)
Patients randomised to the ‘delayed’ exercise intervention group will receive “usual care”, and will not be offered the additional (experimental) exercise intervention for the initial 10 weeks following baseline assessment. There will be no specific mention of the need to exercise other than that contained in generic information provided by treating teams, that is provided to all patients as part of the usual standard of care. Additionally there will be no advice on exercise offered by the WA YCS AEP. Participants randomised to the delayed exercise intervention group will be informed that following the assessment at 10 weeks, they will commence their exercise intervention. Participants in the delayed group will be provided with an exercise diary to record their activity levels over the initial 10-week delayed block. Additionally, participants will be followed up weekly by Youth Cancer Service nursing staff to record their activity levels. It is not expected that this group will complete any exercise in the initial 10 weeks post baseline assessment. Following the interim assessment at 10 weeks this group will then commence 10 weeks of structured supervised exercise, following the same protocol as the immediate exercise intervention group to 20 weeks.
Control group
Active

Outcomes
Primary outcome [1] 323819 0
To determine whether a 10-week individualised exercise intervention is associated with a reduced decline in physical fitness (VO2 peak- as measured by a sub maximal ramp protocol cycle ergometer test ) when compared with controls in 15 – 25 year old patients undergoing treatment for cancer from diagnosis.
Timepoint [1] 323819 0
baseline- 10 weeks (primary timepoint)- 20 weeks.
Secondary outcome [1] 382986 0
To determine the impact of an exercise program on muscular strength as measured by 1-repetition maximum strength testing specifically in AYA cancer patients undergoing treatment.
Timepoint [1] 382986 0
Baseline - 10 weeks- 20 weeks
Secondary outcome [2] 382987 0
To determine the impact of an exercise program on psychological distress as measured by the PEDS-QL specifically in AYA cancer patients undergoing treatment.
Timepoint [2] 382987 0
0-10-20 weeks
Secondary outcome [3] 382988 0
To evaluate the overall impact of an exercise program on treatment-related toxicities as graded by the Common terminology criteria for adverse events version 5 (CTCAE), specifically in AYA cancer patients.
Timepoint [3] 382988 0
0-10-20 weeks
Secondary outcome [4] 383388 0
Changes in body composition as measured by DXA
Timepoint [4] 383388 0
baseline - 10 weeks-20 weeks
Secondary outcome [5] 383389 0
Changes in functional capacity as measured by 30 seconds push ups, sit ups and sit to stands
Timepoint [5] 383389 0
baseline-10 weeks and 20 weeks.
Secondary outcome [6] 383390 0
Changes in fatigue as measured by the PEDS-QL multidimensional fatigue scale.
Timepoint [6] 383390 0
baseline- 10 weeks and 20 weeks.
Secondary outcome [7] 383391 0
changes in self reported quality of life as measured by the EORTC-QLQc30
Timepoint [7] 383391 0
baseline- 10 weeks and 20 weeks.
Secondary outcome [8] 383392 0
Changes in chemotherapy dosage modification as recorded in participant medical records
Timepoint [8] 383392 0
20 weeks.

Eligibility
Key inclusion criteria
- Participants must be aged between 15 and 25 years of age
- Diagnosed with a primary haematological malignancy or solid tumour.
- Scheduled to commence or commenced systemic cancer treatment e.g. chemotherapy, radiation therapy or a combination of both within a +- 2 week period (participants who have undergone surgery will only be eligible for the trial if surgery is used in combination with chemotherapy or radiation).
- Medically stable (as determined by their treating medical practitioner) with written clearance from a doctor in their treating team to undertake a progressive exercise program.
Minimum age
15 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cognitive impairment (determined by a medical practitioner)
- Patients who undergo surgery only
- <6 months life expectancy
- Absolute contraindications to exercise e.g. unstable angina, uncontrolled heart failure, acute systemic infection accompanied by fever.
- Insufficient English to participate in the exercise programme and exercise assessments, or to complete the questionnaire.
- Pregnant or lactating.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The FiGHTINGF!T trial is a prospective, single centre, randomised controlled (RCT) cross over trial. Following baseline assessments, the design will have participants randomised to either immediate exercise or delayed exercise (usual care) for an initial 10 weeks. Following interim assessments at 10 weeks, participants will cross to the opposing group and either commence exercise (delayed exercise group) or commence usual care. There will be no wash out period between groups.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be conducted utilising IBM SPSS. A series of two way repeated measures ANOVA will be utilised to identify any changes over time both within and between groups. Correlational analysis will be utilised to identify the factors contributing to treatment completion rates and recorded toxicities.

Recruitment
Recruitment status
Recruiting
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)
WA
Recruitment hospital [1] 16685 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 30284 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 305738 0
Charities/Societies/Foundations
Name [1] 305738 0
Sony Foundation- You Can Innovate Award
Address [1] 305738 0
11-19 Hargrave Street, East Sydney NSW 2010
Country [1] 305738 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling highway, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 306164 0
Hospital
Name [1] 306164 0
Sir Charles Gairdner Hospital
Address [1] 306164 0
Gairdner Drive, Nedlands, WA, 6006
Country [1] 306164 0
Australia
Other collaborator category [1] 281316 0
Other
Name [1] 281316 0
WA Youth Cancer Service
Address [1] 281316 0
Sir Charles Gairdner Hospital
Locked Bag 2012,
Nedlands WA 6009
Country [1] 281316 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306013 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 306013 0
Sir Charles Gairdner Hospital
2nd Floor A Block
Hospital Avenue
NEDLANDS Western Australia 6009
Ethics committee country [1] 306013 0
Australia
Date submitted for ethics approval [1] 306013 0
16/02/2018
Approval date [1] 306013 0
21/02/2018
Ethics approval number [1] 306013 0

Summary
Brief summary
The purpose of this study is to assess if a structured exercise program will have an effect on physical fitness, strength and quality of life. We also aim to assess if exercise has any impact on treatment related side effects or chemotherapy dosage modifications.

Who is it for?

You may be eligible for this study if you are aged between 15-25 years old and have either commenced treatment for cancer in the past two weeks or are due to commence in the next two weeks.

Study details

Participants enrolled in this study will be randomly divided into two groups:
- Group 1 will receive an exercise program shortly after enrolling in this study, which will involve both aerobic exercise (walking, cycling, etc.) and a strength component. Participants in this group will need to attend two face-to-face exercise sessions per week and are also expected to complete some exercise at home, for 10 weeks.
- Group 2 will need to record the exercise they complete in their day-to-day activities for 10 weeks. After this, they will then also receive an exercise program similar to that completed by Group 1.

As part of this study, all participants will need to complete questionnaires and functional assessments at baseline, week 10, and week 20. Participants will also be required to undergo weekly blood tests to ensure they are within safety parameters to complete the exercise program. These results will also be used to record any treatment toxicities.

It is hoped that this research will help in determining if exercise is effective in decreasing decline in physical fitness, while also improving psychosocial outcomes during cancer treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102418 0
Ms Claire Munsie
Address 102418 0
WA Youth Cancer Service
Sir Charles Gairdner Hospital
Locked bag 2012
NEDLANDS WA 6009
Country 102418 0
Australia
Phone 102418 0
+61466342916
Fax 102418 0
Email 102418 0
claire.munsie@health.wa.gov.au
Contact person for public queries
Name 102419 0
Ms Claire Munsie
Address 102419 0
WA Youth Cancer Service
Sir Charles Gairdner Hospital
Locked bag 2012
NEDLANDS WA 6009
Country 102419 0
Australia
Phone 102419 0
+61466342916
Fax 102419 0
Email 102419 0
claire.munsie@health.wa.gov.au
Contact person for scientific queries
Name 102420 0
Ms Claire Munsie
Address 102420 0
WA Youth Cancer Service
Sir Charles Gairdner Hospital
Locked bag 2012
NEDLANDS WA 6009
Country 102420 0
Australia
Phone 102420 0
+61466342916
Fax 102420 0
Email 102420 0
claire.munsie@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Given the small cohort of patients included in this study it would be impossible to secure their anonymity should their data be made available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results