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Trial registered on ANZCTR


Registration number
ACTRN12616001669482
Ethics application status
Approved
Date submitted
1/12/2016
Date registered
5/12/2016
Date last updated
12/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a community based exercise program for people with cancer
Scientific title
Effect of a community based exercise program on quality of life for people with cancer
Secondary ID [1] 290668 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 301200 0
Condition category
Condition code
Cancer 300959 300959 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Cancer Council WA Life Now Exercise program intervention consists of a pre- and post- program individual exercise physiologist consultation and 3 months of twice weekly group-based exercise sessions administered in community exercise clinics under the supervision of exercise physiologists specifically trained to deliver the Life Now Exercise program. The twice weekly exercise sessions are conducted in groups of approximately 10 participants under the supervision of an accredited exercise physiologist. The maximum number of participants per group is 15-20 (site dependent) and the groups are administered with an exercise physiologist to participant ratio of up to 1:10. The sessions last approximately 1 hour in duration and consist of a combination of moderate to high intensity aerobic and resistance exercise as well as flexibility exercises. The aerobic exercise component includes 20 to 30 minutes of at least moderate intensity cardiovascular exercise using a variety of modes such as walking or jogging on a treadmill, cycling or rowing on a stationary ergometer. The target intensity is between 60 to 85% of estimated heart rate maximum. The resistance exercise component involves 6 to 10 exercises that target the major upper and lower body muscle groups. Target intensity is 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. Resistance exercise selection is individually prescribed. The flexibility component involves approximately 5 minutes of stretching of the major muscle groups for 15-30 second duration each. Exercise prescription is progressive and modified according to individual response. Session ratings of perceived exertion (RPE) are recorded after the completion of each exercise session to monitor the perceived intensity of the exercise using the 6 – 20 Borg scale. The target session RPE range is 12 – 16. Participants are encouraged to undertake additional home-based aerobic exercise with the goal of achieving a total of at least 150 minutes of moderate intensity aerobic exercise each week (accumulated through the combination of clinic- and home-based sessions). Compliance and attendance (including the reason for any missed sessions) will be tracked throughout the program by the EP. Additionally patients will be asked to document their home-based aerobic exercises in a training diary.
Intervention code [1] 296550 0
Lifestyle
Intervention code [2] 296556 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300377 0
Health-related quality of life determined by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Timepoint [1] 300377 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [1] 329827 0
Physical function determined by 400 metre walk and repeated chair rise test
Timepoint [1] 329827 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [2] 329828 0
Cancer specific quality of life determined by the European Organisation for Research and Treatment of Cancer (QLQ-C-30) questionnaire
Timepoint [2] 329828 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [3] 329829 0
Cancer-related fatigue determined by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale
Timepoint [3] 329829 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [4] 329830 0
Psychological distress determined by the Brief Symptom Inventory-18 (BSI-18)
Timepoint [4] 329830 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [5] 329831 0
Self-reported exercise levels determined by the Godin Leisure-Time Exercise Questionnaire (modified to include participation in resistance exercise)
Timepoint [5] 329831 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [6] 329832 0
Exercise motivation derived from the Theory of Planned Behaviour and determined by using validated questionnaires (theory of planned behaviour exercise motivation survey)
Timepoint [6] 329832 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [7] 329833 0
Resting blood pressure determined by validated oscillometric device or sphygmomanometer
Timepoint [7] 329833 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [8] 329834 0
Waist and hip circumferences determined by constant tension anthropometric tape
Timepoint [8] 329834 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [9] 329835 0
Whole body composition determined in a subset of participants (all participants willing to attend a tertiary assessment centre for additional assessments) using dual-energy X-ray absorptiometry
Timepoint [9] 329835 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [10] 329836 0
Upper and lower body strength determined in a sub-set of participants (all participants willing to attend a tertiary assessment centre for additional assessments) by using the 1RM in the leg press, chest press and seated row exercises
Timepoint [10] 329836 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [11] 329837 0
Ambulatory ability determined in a subset of participants (all participants willing to attend a tertiary assessment centre for additional assessments) by using the usual and fast pace 6 metre walk
Timepoint [11] 329837 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [12] 329838 0
Dynamic balance determined in a subset of participants (all participants willing to attend a tertiary assessment centre for additional assessments) by using the 6 metre backwards walk
Timepoint [12] 329838 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [13] 329839 0
Static balance determined in a subset of participants (all participants willing to attend a tertiary assessment centre for additional assessments) by using the sensory organisation test performed on a Neurocom Smart Balancemaster (Neurocom, OR, USA)
Timepoint [13] 329839 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [14] 329840 0
Cost-effectiveness based on costs and health outcomes to determine the incremental cost-effectiveness ratio (ICER) in dollars per quality adjusted life years (QALY) gained. QALYs will be derived from the SF-6D utility index score obtained from the SF-36 using standard methods. Cost of delivering the intervention will be monitored by research assistants.
Timepoint [14] 329840 0
Post-intervention (3 months)
Secondary outcome [15] 329841 0
Uptake determined by participation rate and number of patients who register but do not commence participation in the program
Timepoint [15] 329841 0
Throughout the intervention
Secondary outcome [16] 329857 0
Adherence determined by attendance of the exercise and assessment sessions
Timepoint [16] 329857 0
Throughout the intervention
Secondary outcome [17] 329858 0
Safety determined by incidence and severity of any adverse events (e.g. muscle pulls or strains, falls, abnormal blood pressure, fainting, light-headedness, muscle cramps or strain, nausea, and in very rare cases heart rhythm disturbances or heart attack (risk is 1 in 49,565 patient training hours in cardiac rehabilitation)). 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 administered after the intervention and follow-up periods.
Timepoint [17] 329858 0
Throughout the intervention
Secondary outcome [18] 329867 0
BMI determined by height and weight measures
Timepoint [18] 329867 0
Baseline (0 months) and post-intervention (3 months)
Secondary outcome [19] 329868 0
Bone mineral density determined in a subset of participants (all participants willing to attend a tertiary assessment centre for additional assessments) using dual-energy X-ray absorptiometry
Timepoint [19] 329868 0
Baseline (0 months) and post-intervention (3 months)

Eligibility
Key inclusion criteria
1) People with any diagnosis of cancer who are currently receiving treatment or within two years of completing treatment for cancer
2) Physician consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Neutropenia; 2) severe anaemia; 3) bone metastases; or 4) any musculoskeletal, cardiovascular or neurological disorder that could place the participant at risk of injury or illness resulting from the exercise program (as determined by the patient’s physician).

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
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

Funding & Sponsors
Funding source category [1] 295099 0
Charities/Societies/Foundations
Name [1] 295099 0
Cancer Council Western Australia
Address [1] 295099 0
420 Bagot Road
Subiaco WA 6008
Country [1] 295099 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Exercise Medicine Research Institute
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 293917 0
Individual
Name [1] 293917 0
A/Prof Prue Cormie
Address [1] 293917 0
Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country [1] 293917 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296450 0
Human Research Ethics Committee
Ethics committee address [1] 296450 0
Edith Cowan University
Research Ethics
270 Joondalup Drive
Joondalup, WA 6027
Ethics committee country [1] 296450 0
Australia
Date submitted for ethics approval [1] 296450 0
Approval date [1] 296450 0
03/12/2010
Ethics approval number [1] 296450 0
6192 CORMIE

Summary
Brief summary
The primary purpose of this trial is to evaluate the efficacy of a community-based exercise program, The Life Now Exercise Program, for improving physical and psychosocial wellbeing in cancer patients and survivors. The exercise program is hypothesized to improve wellbeing in people with cancer.

Who is it for?
You may be eligible to enroll in this trial if you are aged 18 or over and are currently receiving cancer treatment or completed cancer treatment within the previous two years.

Study details
All participants enrolled in this trial will complete the Life Now Exercise Program. This involves twice weekly supervised group exercise sessions for three months. Sessions will last approximately one hour and comprise of a combination of aerobic, strength and flexibility training. Participants will also be asked to complete home exercise of their choosing to a total of at least 150 minutes of exercise per week, including the supervised sessions.

It is hoped that this trial will provide information on whether an exercise program can mitigate and rehabilitate the adverse effects of cancer and its treatment and improve physical and psychosocial wellbeing amongst current cancer patients and recent cancer survivors.
Trial website
Trial related presentations / publications
The trial protocol has been published: Cormie P, Lamb S, Newton RU, Valentine L, McKiernan S, Spry N, Joseph D, Taaffe DR, Doran CM, Galvão DA. Implementing exercise in cancer care: study protocol to evaluate a community-based exercise program for people with cancer. BMC Cancer. 2017 Feb 6;17(1):103.

Manuscripts are currently in preparation focusing on the outcomes of the trial
Public notes

Contacts
Principal investigator
Name 70902 0
A/Prof Prue Cormie
Address 70902 0
Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 70902 0
Australia
Phone 70902 0
+61 (0)3 9230 8242
Fax 70902 0
Email 70902 0
prue.cormie@acu.edu.au
Contact person for public queries
Name 70903 0
A/Prof Prue Cormie
Address 70903 0
Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 70903 0
Australia
Phone 70903 0
+61 (0)3 9230 8242
Fax 70903 0
Email 70903 0
prue.cormie@acu.edu.au
Contact person for scientific queries
Name 70904 0
A/Prof Prue Cormie
Address 70904 0
Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 70904 0
Australia
Phone 70904 0
+61 (0)3 9230 8242
Fax 70904 0
Email 70904 0
prue.cormie@acu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary