Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001084178
Ethics application status
Approved
Date submitted
17/07/2019
Date registered
6/08/2019
Date last updated
6/08/2019
Date data sharing statement initially provided
6/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Safety, Feasibility and Effectiveness of the Young Men's Christian Association (YMCA) Cancer Survivors' Program
Scientific title
The Safety, Feasibility and Effectiveness of the YMCA Cancer Survivors' Program
Secondary ID [1] 298682 0
Nil
Universal Trial Number (UTN)
U1111-1236-7357
Trial acronym
YMCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 313577 0
Condition category
Condition code
Cancer 312011 312011 0 0
Any cancer
Physical Medicine / Rehabilitation 312181 312181 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a 12-week exercise program. The program will consists of a warm up, aerobic exercise, resistance based exercise (body weight, resistance machines, free weights), balance, flexibility and a cool-down. The exercise sessions will be held in groups at the YMCA fitness centres across South-East Queensland. Sessions will be held twice a week, one hour duration, for a 12-week period. The participant will be under the supervision of a YMCA specialised trainer for the cancer program. 

The program will be small group training (~10) with one trainer. The level of intensity will be moderate-to-vigorous for cardiorespiratory and progressive resistance training components of the program. The flexibility and balance will be low intensity. Borg's Rating of Perceived Exertion will be used alongside % of age predicted heart rate maximum.
Example of resistance work out (the regression exercise is listed on left). The resistance component will consist of 2 sets and 12 reps as prescribed by the exercise physiologist.
- Chest press or push ups
- shoulder press or dumbbell press
- leg extension or sit to stand
- lateral arm raise or front raise
- calf raise machine or step ups
- tricep extensions or cable pull down
- leg raises or sit ups
This is followed by aerobic exercise component which consists of moderate-to-vigorous intensity aerobic exercise on equipment (e.g. treadmill or stationary bike). To finish the session there will be balance and flexibility exercises. Examples will be tandem walking and static stretching.
All exercise programs were developed by an exercise physiologist. There are set exercises for each program targeting large muscle groups. Each program written by the exercise physiologist will consists of approximately 8 resistance style exercises, aerobic training, balance and flexibility exercises. The exercise intervention is not personalised based on participant goals. However, exercises will be modified to adapt for individual abilities. E.g. if a participant cannot perform a conventional push up, they can do a modified push up on a wall to regress the exercise.
Intervention code [1] 314952 0
Lifestyle
Comparator / control treatment
1. Single-subject design is implemented. The participant is exposed to the intervention after 3-months of usual care has been performed. Usual care is defined as a 12-week period in which the participant continues their normal practices and lifestyle. Participants are encouraged to live their normal lifestyle and routines.
Control group
Active

Outcomes
Primary outcome [1] 320653 0
Change in time to complete the Trail-Making-Test assessed by a digital stopwatch.
Timepoint [1] 320653 0
Baseline, 2-weeks post usual care, 2-weeks post intervention completion (primary time point), 6-months post intervention, 12-months post intervention.
Primary outcome [2] 320654 0
Assessing Safety of YMCA Cancer Survivors' Program through reporting of adverse events and serious adverse events. Adverse events are recorded on a study specific questionnaire after the completion of each training session. The questionnaire has a question if any adverse events occur; if yes, the user is prompted to answer further questions about the event.
These include:
1. Please provide details of any personal injury resulting from the accident/incident
2. Was medical assistance sought?
3. Name and contact details of the medical personnel involved
4. Provide details of the action immediately taken following the incident/accident
5. Provide the details of the instrumental actions taken in the incident/accident 'clean up'
6. Provide details of preventative measures adopted following the incident/accident.
Timepoint [2] 320654 0
Safety will be measured during the 12-week exercise intervention period. Therefore, specific time-points will be the participant's first session (start of intervention) and participant's final session (end of intervention). The participant will complete 2 sessions per week for a 12-week period.
This is not a part of the assessment battery completed prior to the intervention and after. As it is assessing the exercise safety and feasibility it will only be completed at exercise sessions.
Primary outcome [3] 320655 0
Assessing feasibility of YMCA Cancer Survivors' Program through attendance and adherence to exercise intervention. Attendance and adherence will be measured through a study specific questionnaire, which is on a database (Smartabase). The questionnaire asks if the participant completed full session, if no it will prompt:
1. What approximate % of the session did they complete? (slide to 0% if no attendance)
2. Why did the participant not complete the full session? Prompt a drop down box with various reasons including: illness, fatigue, time commitment, work commitment etc. There is a prompt for 'other reason' if not listed.
Timepoint [3] 320655 0
Feasibility will be measured during the 12-week exercise intervention period only. Therefore, specific time-points will be the participant's first session (start of intervention) and participant's final session (end of intervention). The participant will complete 2 sessions per week for a 12-week period.
This is not a part of the assessment battery completed prior to the intervention and after. As it is assessing the exercise safety and feasibility it will only be completed at exercise sessions.
Secondary outcome [1] 372345 0
Exercise capacity assessed using the six minute walk test
Timepoint [1] 372345 0
Baseline, within 2-weeks post usual care, within 2-weeks post intervention completion, 6-months post intervention, 12-months post intervention.
Secondary outcome [2] 372346 0
Body composition changes assessed by dual energy X-ray absorptiometry (DXA). DXA will be used to assess bone mineral density.
Timepoint [2] 372346 0
Baseline, within 2-weeks post usual care, within 2-weeks post intervention completion, 6-months post intervention, 12-months post intervention.
Secondary outcome [3] 372347 0
Muscular strength assessed by an isometric mid-thigh pull
Timepoint [3] 372347 0
Baseline, within 2-weeks post usual care, within 2-weeks post intervention completion, 6-months post intervention, 12-months post intervention.
Secondary outcome [4] 372348 0
Flexibility assessed by chair sit and reach test
Timepoint [4] 372348 0
Baseline, within 2-weeks post usual care, within 2-weeks post intervention completion, 6-months post intervention, 12-months post intervention.
Secondary outcome [5] 372349 0
Balance assessed by modified star excursion test
Timepoint [5] 372349 0
Baseline, within 2-weeks post usual care, within 2-weeks post intervention completion, 6-months post intervention, 12-months post intervention.
Secondary outcome [6] 372350 0
Subjective changes in cognition assessed by functional assessment of cancer therapy - cognition (FACT-Cog) questionnaire
Timepoint [6] 372350 0
Baseline, within 2-weeks post usual care, within 2-weeks post intervention completion, 6-months post intervention, 12-months post intervention.
Secondary outcome [7] 372351 0
Health-related quality of life assessed by Functional Assessment of Cancer Therapy - General
Timepoint [7] 372351 0
Baseline, within 2-weeks post usual care, within 2-weeks post intervention completion, 6-months post intervention, 12-months post intervention.
Secondary outcome [8] 372352 0
Depression, anxiety and stress assessed by the Depression, Anxiety and Stress Scale (DASS)
Timepoint [8] 372352 0
Baseline, within 2-weeks post usual care, within 2-weeks post intervention completion, 6-months post intervention, 12-months post intervention.
Secondary outcome [9] 372353 0
Insomnia and sleep difficulties assessed by Insomnia Severity Index (ISI) questionnaire
Timepoint [9] 372353 0
Baseline, within 2-weeks post usual care, within 2-weeks post intervention completion, 6-months post intervention, 12-months post intervention.
Secondary outcome [10] 372354 0
Cancer-related fatigue levels assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Timepoint [10] 372354 0
Baseline, within 2-weeks post usual care, within 2-weeks post intervention completion, 6-months post intervention, 12-months post intervention.
Secondary outcome [11] 372355 0
Physical activity assessed by 7-day waist worn accelerometry. The accelerometry will be used to assess time in moderate-to-vigorous physical activity and sedentary time.
Timepoint [11] 372355 0
Baseline, within 2-weeks post usual care, within 2-weeks post intervention completion, 6-months post intervention, 12-months post intervention.
Secondary outcome [12] 373333 0
Body composition changes assessed by dual energy X-ray absorptiometry (DXA). DXA will be used to assess body fat percentage.
Timepoint [12] 373333 0
Baseline, within 2-weeks post usual care, within 2-weeks post intervention completion, 6-months post intervention, 12-months post intervention.
Secondary outcome [13] 373334 0
Body composition changes assessed by dual energy X-ray absorptiometry (DXA). DXA will be used to assess lean muscle mass.
Timepoint [13] 373334 0

Baseline, within 2-weeks post usual care, within 2-weeks post intervention completion, 6-months post intervention, 12-months post intervention.

Eligibility
Key inclusion criteria
- Have a histologically confirmed diagnosis of cancer
- Over 18 years of age
- Gained medical advice from doctor with completed medical history form
- Ability to read English to a grade 10 level to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Individuals with no histologically confirmed diagnosis of cancer
- Individuals under 18 years old
- Inability to gain consent

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Raw data will be analysed via relevant software packages. Statistical analysis will be conducted on IBM SPSS Statistics for iOS and Microsoft Excel on a username and password protected computer. Data will be assessed for normality using the Shapiro-Wilk test. Subsequent analysis will include standard deviation statistics, t tests, correlation, regression and one-way repeated ANOVA or the comparable non-parametric test as necessary to examine difference among time-points. Differences in secondary outcomes will be evaluated using multi-level analyses. A time x group interaction term will be used to formally test for difference between groups (alpha = 0.05). All tests will be two-tailed and an alpha level of 0.05 will be applied as the criterion for statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2019
Actual
Date of last participant enrolment
Anticipated
9/12/2019
Actual
Date of last data collection
Anticipated
9/12/2020
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 27140 0
4072 - University Of Queensland
Recruitment postcode(s) [2] 27141 0
4165 - Victoria Point
Recruitment postcode(s) [3] 27142 0
4074 - Jamboree Heights
Recruitment postcode(s) [4] 27143 0
4006 - Bowen Hills
Recruitment postcode(s) [5] 27144 0
4059 - Kelvin Grove
Recruitment postcode(s) [6] 27145 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 303232 0
University
Name [1] 303232 0
The University of Queensland - School of Human Movements
Country [1] 303232 0
Australia
Funding source category [2] 303235 0
Commercial sector/Industry
Name [2] 303235 0
YMCA Brisbane
Country [2] 303235 0
Australia
Primary sponsor type
Individual
Name
Dr Tina Skinner
Address
Corner of Blair and Union Drive, Connell Building (26), The University of Queensland, St Lucia, 4067
Country
Australia
Secondary sponsor category [1] 303236 0
Individual
Name [1] 303236 0
Eliza Keating
Address [1] 303236 0
Corner of Blair and Union Drive, Connell Building (26), The University of Queensland, St Lucia, 4067
Country [1] 303236 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303778 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 303778 0
Ethics committee country [1] 303778 0
Australia
Date submitted for ethics approval [1] 303778 0
19/03/2019
Approval date [1] 303778 0
15/07/2019
Ethics approval number [1] 303778 0
2019000634

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

Contacts
Principal investigator
Name 94770 0
Ms Eliza Keating
Address 94770 0
Corner of Blair and Union Drive, Connell Building (26), The University of Queensland, St Lucia, Queensland, 4067
Country 94770 0
Australia
Phone 94770 0
+61 488922442
Fax 94770 0
Email 94770 0
[email protected]
Contact person for public queries
Name 94771 0
Eliza Keating
Address 94771 0
Corner of Blair and Union Drive, Connell Building (26), The University of Queensland, St Lucia, Queensland, 4067
Country 94771 0
Australia
Phone 94771 0
+61 488922442
Fax 94771 0
Email 94771 0
[email protected]
Contact person for scientific queries
Name 94772 0
Eliza Keating
Address 94772 0
Corner of Blair and Union Drive, Connell Building (26), The University of Queensland, St Lucia, Queensland, 4067
Country 94772 0
Australia
Phone 94772 0
+61 488922442
Fax 94772 0
Email 94772 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?
Grouped data will be presented in international peer reviewed publications. Once data are published there will be a statement that data can be made available upon request.
When will data be available (start and end dates)?
The data will be available when published and accepted into international peer reviewed publications. There are no anticipated dates as of yet.
Available to whom?
Grouped data will be made available once a request has been submitted the author after the publication in peer-reviewed publications.
Available for what types of analyses?
The data will be available for any purpose, provided the seeker has made an appropriate request. Group data will only be available.
How or where can data be obtained?
The data can be obtained by contacting the author once it is has been published in peer-reviewed publications.


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.