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Trial registered on ANZCTR


Registration number
ACTRN12620000664943
Ethics application status
Approved
Date submitted
18/05/2020
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
Can the Life Now exercise program improve physical functioning and quality of life in adolescent and young adult cancer survivors?
Scientific title
Contribution of Cancer Council Life Now exercise program to physical functioning and quality of life in adolescent and young adult cancer survivors.
Secondary ID [1] 301280 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 317458 0
Condition category
Condition code
Cancer 315558 315558 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prior to commencing the exercise intervention participants will undergo rigorous baseline functional testing. This will include:
1. 400m walk time: measures the time taken to cover 10 laps over a 20m track equalling 400m. It is self-paced and sub maximal and reflects the functional exercise level for daily physical activities. The 400m walk time is reproducible and sensitive to change.
2. Repeated chair rise tests: participants are instructed to rise from seated on a chair to a full standing position and then return to a full sitting position five times as fast as possible.
3. Limb strength:
-1 RM chest press – participant is set up lying on their back with the barbell at chest level, gripping the bar at outside shoulder width and elbows at right angles. Correct technique is practiced with no weight. Adequate rest (2mins) is given between each set. Begin at a 6RM weight, incrementally increasing until 1 repetition is all that can be performed.
-1RM Leg Press – participant is seated incline with feet shoulder width on the platform. Correct technique is practiced with no weight. Adequate rest (2mins) is given between each set. Begin at a 6RM weight, incrementally increasing until 1 repetition is all that can be performed.
4. Body Mass and body composition (BMI): Patient weight, height, body mass index (BMI) and waist circumference measurements will be taken.
5. Body Composition – Bone mineral density (BMD), lean and fat tissue will be assessed using dual energy x-ray absorptiometry (DXA). BMD of the whole body, hip and lumbar spine will be examined as well as regional and whole body lean and fat mass. Trunk adiposity will be assessed using trunk fat mass measures while region specific changes in muscle hypertrophy and/or atrophy will be examined using limb and trunk lean tissue measures obtained from the whole body scan. This scan will be optional for participants. They will have the opportunity to opt-in for the DXA (as indicated on the consent form). If participants choose not to have the DXA they will not be excluded for the project, nor will it change their treatment within the project).
6. Waist and Hip Circumference: the narrowest point around the waist and greatest around the hips is measured with a tape measure.
7. Submaximal Bike test: participant is seated on an upright bike pedalling at 50rpm with the bike set at 25 Watts for 3 minutes. Each minute the resistance is incrementally increased by 25 Watts until participant reaches 85% HR Max. Participant cycles for 3 minutes to cool down.
8. Psychosocial Quality of Life Evaluation: EORTC-QLQC30, SF-36, Godin Leisure Time physical activity questionnaire.

Intervention
Participants will complete 12 weeks of supervised individualised exercise sessions twice per week in a group based setting. Each group will consist of no more than 15 participants and supervised by an Accredited Exercise Physiologist. The sessions will be approximately 60 minutes in length and be conducted in a community setting. Exercise programs for all participants will be mixed mode; incorporating a combination of aerobic and resistance exercises. 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). Each training session will commence with a 10 minute warm-up consisting of low level aerobic activity (i.e. walking, stationary cycling etc) and stretching. Following warm-up, participants will complete the resistance training component of the exercise program involving six exercises that target the major lower body and upper body muscle groups. The intensity of the resistance exercises will be manipulated from 6-12 repetition maximum (6-12RM - i.e. the maximal weight that can be lifted 6 to 12 times) using 1-4 sets per exercise. Participants will complete 20-30 minutes of aerobic exercise per session at 60-85% of predicted HR max.
Following the 12 week intervention participants will complete post-intervention assessments to assess any changes over time.
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] 317587 0
Lifestyle
Intervention code [2] 317700 0
Rehabilitation
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323802 0
To determine the impact of a 12 week exercise intervention on cardio-respiratory fitness as measured by a submaximal bike test (Vo2 peak)
Timepoint [1] 323802 0
12 weeks
Secondary outcome [1] 382937 0
To determine the impact of a 12 weeks exercise program on strength as measured using 1-repetition maximum results.
Timepoint [1] 382937 0
12 weeks
Secondary outcome [2] 382938 0
To determine the impact of a group based exercise program on AYA quality of life as measured using the EORTC-QLQc30.
Timepoint [2] 382938 0
12 weeks
Secondary outcome [3] 383405 0
To determine the impact of a 12 weeks exercise program on functional capacity using the 30 seconds push ups, sit ups and sit to stands.
Timepoint [3] 383405 0
12 weeks.
Secondary outcome [4] 383406 0
To determine the impact of a 12 weeks exercise program on fitness as measured using the 400m timed walk
Timepoint [4] 383406 0
12 weeks.

Eligibility
Key inclusion criteria
Patients will be considered for the trial if they meet the following criteria:
Participants must be enrolled in the Life Now Exercise Program
Aged between 15-27 years
Have completed primary treatment for cancer (surgery, chemotherapy, radiotherapy) within the last 2 years.
Able to provide informed consent.
Minimum age
15 Years
Maximum age
27 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they meet the following criteria:
Unable to read and understand English
Patient deemed not safe to undertake moderate intensity exercise or have the following contra-indications to exercise testing which include the following:
Myocardial infarction or unstable angina in last 3 months
Cerebrovascular event or transient ischemic attack in last 3 months
Pulmonary embolic event within 3 months, existing acute or chronic deep vein thrombosis
Pregnancy
Presentation with active sepsis
Have not obtained medical clearance from their treating teams.
Presence of bone metastases.
Severe anemia (Hb <80g/L for men and women)
Neutropaenia
Development of an acute illness, in addition to the initial cancer diagnosis.

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data will be analysed using SPSS. One way repeated measures ANOVA and t-tests will be utilised to identify significant changes over time. Descriptive statistics and correlations will also be identified. All tests will be two-tailed and an alpha level of 0.05 (two-tailed) will be applied as the criterion for statistical significance

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] 16664 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 30260 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 305725 0
Government body
Name [1] 305725 0
Cancer Australia - 2017 Supporting people with cancer Grant initiative
Address [1] 305725 0
Cancer Australia
Level 14, 300 Elizabeth Street
Surrey Hills, NSW 2010
Country [1] 305725 0
Australia
Primary sponsor type
Hospital
Name
Western Australian Youth Cancer Service
Address
You Can Centre, Ground Floor, DD Block
Sir Charles Gairdner Hospital
Locked Bag 2012, Nedlands, WA, 6009
Country
Australia
Secondary sponsor category [1] 306183 0
None
Name [1] 306183 0
Address [1] 306183 0
Country [1] 306183 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306000 0
Sir Charles Gairdner Osborne Park
Ethics committee address [1] 306000 0
Department of Research
Level 2, A Block, Hospital Ave Nedlands, WA 6009
Ethics committee country [1] 306000 0
Australia
Date submitted for ethics approval [1] 306000 0
20/05/2016
Approval date [1] 306000 0
30/06/2016
Ethics approval number [1] 306000 0
2016-088

Summary
Brief summary
The aim of this study to assess the Cancer Council Life Now exercise program contribution to physical functioning and quality of life in adolescent and young adult cancer survivors.

Who is it for?
You may be eligible for this study if you are aged between 15-27 years, have completed your cancer treatment within the previous 2 years and are enrolled in the Life Now exercise program.

Study details
Participants who have completed treatment for cancer in the last two years will be offered a 12 week exercise rehabilitation program in a group based setting (twice per week). The program will combine resistance and cardiovascular training. Findings from the initial assessments will inform the development and prescription of an appropriate exercise program for each individual by an accredited Exercise Physiologist.
Effects of the exercise program upon physical functioning (strength, cardiovascular fitness and functional capacity) and quality of life (completion of questionnaires) will be measured following completion of the 12 week program.

From this research it is hoped we will better understand the impact that exercise has on adolescents and young adults (AYAs) who have completed treatment for cancer. If this research demonstrates positive benefits in this cohort, it is expected that it will support the necessary integration of this program into AYA standard of care for cancer treatment.
Trial website
Trial related presentations / publications
Public notes
Other Cancer types: Adolescent and Young Adult Cancers

Contacts
Principal investigator
Name 102370 0
Ms Claire Munsie
Address 102370 0
You Can Centre, Ground Floor, DD Block
Sir Charles Gairdner Hospital
Locked Bag 2012, Nedlands, WA, 6009
Country 102370 0
Australia
Phone 102370 0
+61 466342916
Fax 102370 0
Email 102370 0
claire.munsie@health.wa.gov.au
Contact person for public queries
Name 102371 0
Ms Claire Munsie
Address 102371 0
You Can Centre, Ground Floor, DD Block
Sir Charles Gairdner Hospital
Locked Bag 2012, Nedlands, WA, 6009
Country 102371 0
Australia
Phone 102371 0
+61 466342916
Fax 102371 0
Email 102371 0
claire.munsie@health.wa.gov.au
Contact person for scientific queries
Name 102372 0
Ms Claire Munsie
Address 102372 0
You Can Centre, Ground Floor, DD Block
Sir Charles Gairdner Hospital
Locked Bag 2012, Nedlands, WA, 6009
Country 102372 0
Australia
Phone 102372 0
+61 466342916
Fax 102372 0
Email 102372 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
Due to the small cohort of patients that this study is investigating it would be impossible to be able to ensure anonymity for participants if their data was made available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results