Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000836134p
Ethics application status
Not yet submitted
Date submitted
24/05/2019
Date registered
11/06/2019
Date last updated
11/06/2019
Date data sharing statement initially provided
11/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercising Right for Bowel Cancer
Scientific title
Exercising Right for Bowel Cancer: A Feasibility Study
Secondary ID [1] 298321 0
Nil known
Universal Trial Number (UTN)
U1111-1234-0591
Trial acronym
ERBC
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Bowel Cancer 312957 0
Condition category
Condition code
Cancer 311454 311454 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Physical Medicine / Rehabilitation 311528 311528 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two groups of participants, "Home Exercise" and "Usual Care". Participants in both groups will be screened for risk to participate in exercise testing by an Accredited Exercise Physiologist (AEP) and be asked standardised questions about their health history related to their current medical condition. Surveys and questionnaires are: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (QLQ-CR29 and QLQ-CR30), The Active Australia questionnaire, The Exercise Confidence Survey, The Cancer Fatigue Scale, and the CSIRO Health Diet Score. Then, if safe to proceed, each participant will undertake an assessment of their body composition (height, weight and body mass index), cardiovascular measures (blood pressure, heart rate, and oxygen saturation), and physical fitness (a Six Minute Walk test, a handgrip test, and a 30 second sit-to-stand test). These assessments will be undertaken by all participants, by the same AEP research assistant at "baseline" (before any intervention), and "follow up" after an 8 week intervention period.

Participants in both groups will be given information handouts at the baseline session on "exercising right for bowel cancer", "eating well with bowel cancer", and "looking after your bowel". These baseline information handouts are publicly available from advocacy websites located:

- "Exercising and Colon Cancer" can be found at Exercise is Medicine -
http://exerciseismedicine.com.au/wp-content/uploads/2016/11/2014-Colon-Cancer-FULL.pdf

- "Eating well with Bowel Cancer" located at: http://www.mediafire.com/download/29q69ghc92nu6lk/Eating_Well_Living_with_Bowel_Cancer_Bowel_Cancer_Australia.pdf

- "Looking after your bowel" can be found at: https://www.continence.org.au/download_attachment.php/72e6c1218d4a5a359ad08be1dcef0f5f/01tA0000001b1daIAA/00PG0000003NBs6MAG/looking-after-your-bowel-booklet.pdf

People volunteering to join the "Home Exercise" group will be prescribed an individualised exercise program by the same AEP who undertakes their baseline and follow up assessments, which will be completed unsupervised at the participants own home over an 8 week intervention period. The home exercise program will be delivered using an exercise prescription and education program called "PhysiTrack", with a user interface app called "PhysiApp".

Because each exercise prescription will be individualised for the participant's physical and emotional circumstances, it cannot be stated exactly what the sessions will encompass in terms of specific exercises, sessions per week, and duration of each session. However, prescriptions will be written according to a standard operating procedure guidebook developed for the study which uses the American College of Sports Medicines 2018 Guidelines for Exercise Testing and Prescription "recommendations for individuals with cancer". Aerobic exercise which may include outdoor walking, in-home aerobic stepping, indoor or outdoor cycling (dependent on what exercise equipment each participant owns at home), or swimming, will be prescribed according to individual preferences with a goal of meeting 150 minutes of moderate intensity aerobic activities over the week. Resistance exercise will be prescribed with a goal of commencing with low intensity, at least one set, and between 8-12 repetitions per exercise. Exercises will be individualised but may involve sit-to-stands, calf raises, bicep curls, chest press, and shoulder rows. Every participant will be offered 1-2 resistance bands of different strengths, at no cost, prescribed to suit their baseline strength (determined by hand grip testing) for use during the study, and to keep after the study has concluded. Flexibility exercises will be prescribed to meet individual needs and limitations and may include stretches for common areas of tightness including chest, hamstrings, shoulders and neck. Each individual exercise session will have a warm up component, an aerobic component, a resistance component, a flexibility component, and a relaxation component.

The relaxation component of the home exercise program will involve 3-5 minutes of supine rest with deep breathing and mindfulness practice. The concepts of mindfulness and relaxation practice will be taught to participants in the Home Exercise Group during week 2, in the first Educational telehealth session, and will center around the Cancer Council's CD
"Mindful Meditation for People with Cancer". Copies of this CD will be given to participants in the Home Exercise group at their baseline testing session for use during the study (and to keep afterwards). A copy of the Mindfulness CD can be ordered from: https://www.cancercouncil.com.au/901/uncategorized/mindful-meditation/

Participants in the Home Exercise group will attend one face to face session with the AEP to be inducted into the use of the smartphone exercise prescription app, and to be coached in their home exercise program. When at home, the exercise program will be delivered using the app that will show the participant a video with coaching of how to undertake their specific exercises. Adherence to exercise prescriptions, and thereby, success and feasibility of the program will be monitored via the app data as frequency of exercise session completions, pain and fatigue monitoring at every exercise session, and by the voluntary participation in a separate baseline and follow up interview / discussion group where participants in the Home Exercise group will be asked their thoughts, beliefs, likes and dislikes about exercise and the use of technology to support health and lifestyle changes, before and after the 8 week exercise intervention. These discussion groups will be led by a researcher not connected with the study and experienced in qualitative research.

People in the "Home Exercise" group will also have 4 x fortnightly, 10-15 minute education chat/question and answer sessions around topics related to the management of their conditions that will be delivered by the lead investigator, via the app using a one - to - one video conferencing feature with topics on:

- Managing stress and Mindfulness during cancer treatment
- Exercising Right for bowel cancer
- Eating right for bowel cancer
- Motivation for exercise and planning for setbacks

These topics will be developed for the study using best practice evidence and presented in plain language for the participants. A brief "workbook" style handout will be given to the participants via email prior to each session, and video links and pdf. handouts will be delivered via the app. Exact timing for the educational telehealth consults will be determined by availability of the lead investigator and the individual participant.

Participants in the Home Exercise group will also receive one weekly text via the app, as a reminder and encouragement to exercise, and the opportunity to ask questions of the researchers about their exercises.

People in the "Usual Care" group will undertake their usual self-care strategies without any further guidance from the research team for the 8 week intervention period. "Usual Care" in this study is defined as following the recommendations of the participants general practitioner and/or oncologist, and/or stoma nurses where appropriate. This may include self-directed activity. All participants will undertake an activity questionnaire (The Active Australia Survey) to quantify their activity levels before and after the 8-week intervention period.
Intervention code [1] 314556 0
Lifestyle
Intervention code [2] 314557 0
Rehabilitation
Intervention code [3] 314558 0
Behaviour
Comparator / control treatment
The comparator is a "Usual Care" group of people who volunteer to undertake the baseline and follow up assessments, but not the home exercise intervention.

People who volunteer for the "Usual Care" group will be offered an individualised exercise and education program at the completion of the study.

"Usual Care" in this study is defined as following the recommendations of the participants general practitioner and/or oncologist, and/or stoma nurses where appropriate. This may include self-directed activity. All participants will undertake an activity questionnaire (The Active Australia Survey) to quantify their activity levels before and after the 8-week intervention period.
Control group
Active

Outcomes
Primary outcome [1] 320170 0
Feasibility and acceptability:
Semi-structured interview questions & discussion groups:
Three-to-four participants in the Exercise Group will be sought with an 'opt in' approach, to attend a pre (baseline timepoint) and a post (follow up timepoint) discussion session where a study investigator experienced in qualitative research methods will explore and record conversations on participant knowledge, attitudes and beliefs around the use of technology to support lifestyle changes.. Pre- and post-intervention semi-structured interview questions will guide small group discussions.
Timepoint [1] 320170 0
Home Exercise Group ONLY
Baseline and (post 8 week intervention) Follow up time points
Primary outcome [2] 320172 0
Physical Function:
The Six Minute Walk Test
The six-minute walk test will be used as the primary measure of physical function. This test requires minimal equipment and is quick and easy to conduct, with walking distance of less than 350m being predictive of increased cardiovascular mortality risk. Participants will be instructed to walk as far as possible along a short measured course during the six minutes. They will be permitted to stop and rest if needed and will receive regular encouragement throughout the test. The 6MWT is a reliable and valid measure of physical function in adults with chronic disease and will be delivered according to standardised operating procedures

Rasekaba, T., et al., The six-minute walk test: a useful metric for the cardiopulmonary patient. Intern Med J, 2009. 39(8): p. 495-501.

Harada, N.D., V. Chiu, and A.L. Stewart, Mobility-related function in older adults: assessment with a 6-minute walk test. Arch Phys Med Rehabil, 1999. 80(7): p. 837-41
Timepoint [2] 320172 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Primary outcome [3] 320249 0
Quality of Life
Health related quality of life will be assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire QLQ-CR-30 questionnaire validated for people with colorectal cancer

Aaronson, N.K., et al., The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst, 1993. 85(5): p. 365-76.
Timepoint [3] 320249 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [1] 370759 0
Feasibility and Acceptability:
PhysiTrack App data will be collected on number of exercise sessions prescribed versus sessions completed
Timepoint [1] 370759 0
Home Exercise Group ONLY
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [2] 370760 0
Functional Capacity (Upper body):
Grip Strength
Grip strength is a reliable and valid measure of upper body strength and is a reliable and valid measure that is widely used in clinical practice. This test will be delivered using a handgrip dynamometer according to the study’s standard operating procedures described below.

Test procedure:

Adjust hand dynamometer to fit the client’s hand grip size, if necessary. Client should be seated, lean forward slightly, with the hand to be tested in front, not touching the body; shoulder should be in neutral, elbow should be at 90 degrees with forearm in neutral (thumb up). Avoid pronation or supination of the wrist as this has been shown to alter the measurement (Richards et al, 1996).

Client should breathe out and perform a maximum gripping effort for a few seconds, whilst keeping the arm stationary. Have the client perform 2 trials for each arm (Note: maximum scores for the right and left hands will be averaged).

Potential Risks: A client may experience a transient rise in blood pressure from breath holding throughout the procedure (a Valsalva manoeuvre). All participants will be screened for safety to perform this procedure at baseline testing session. There is risk of ocular damage from a participant performing a Valsalva manoeuvre (exhaling against a closed glottis) which is mitigated by having the client perform the test while breathing out.



References – Grip Strength Test
Lacy, A. C. (2011). Measurement and evaluation in physical education and exercise science (6th ed.). CA, USA: Pearson Benjamin Cummings.

Richards, L.G., Olson, B., Palmiter-Thomas, P. (1996). How forearm position affects grip strength. Am J Occup Ther; 50:133-8.

Sasaki, H., et al., (2007). Grip strength predicts cause-specific mortality in middle-aged and elderly persons. Am J Med. 120(4): p. 337-42.



Wang, C.Y. and L.Y. Chen, Grip strength in older adults: test-retest reliability and cutoff for subjective weakness of using the hands in heavy tasks. Arch Phys Med Rehabil, 2010. 91(11): p. 1747-51.

Sasaki, H., et al., Grip strength predicts cause-specific mortality in middle-aged and elderly persons. Am J Med, 2007. 120(4): p. 337-42
Timepoint [2] 370760 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [3] 370761 0
Functional Capacity (Lower Body)
The 30s sit to stand test is a functional lower body strength measure that relates to ability to perform activities of daily living and consequently is relevant to wider health and quality of life outcomes. It is a reliable and valid measure that is widely used in clinical practice. This test will be delivered according to the study’s standard operating procedures detailed below:

Equipment required:
• Stopwatch
• Armless chair of standardised height (43 cm) (Rikli & Jones, 2001).

Test procedure:
Ensure the back of the chair is against a wall so that the chair cannot slip. Before completing the test, ensure that the client can complete a single sit to stand. Then instruct the client to fold their arms across their chest and when you say ‘go’, ask them to stand up and sit down as many times as they can in 30 seconds.

Ensure that:
• The client sits with their back against the chair
• The arms are folded across the chest
• The feet remain on the floor throughout the test
• When the client stands, the knees and hips are extended.

Record the time when ‘go’ is said and say ‘stop’ when 30 seconds have passed.
Note: If a client uses their hands during the test, either to push off their thighs or the chair, the test can continue; however, the results cannot be compared to age-related norms. (Adapted from Rikli & Jones, 2001).

References – 30 second Sit-to-Stand Test
Rikli, R. E., & Jones, C. J. (2001). Senior fitness test manual. Illinois, USA: Human Kinetics.




Ritchie, C., et al., Reliability and validity of physical fitness field tests for adults aged 55 to 70 years. J Sci Med Sport, 2005. 8(1): p. 61-70
Timepoint [3] 370761 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [4] 370762 0
Quality of LIfe
A secondary health related quality of life questionnaire will be the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ)-CR29 validated for people with colorectal cancer

Whistance, R.N., et al., Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer, 2009. 45(17): p. 3017-26
Timepoint [4] 370762 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [5] 370763 0
Fatigue:
Level of fatigue will be measured using the validated Cancer Fatigue Scale

Okuyama, T., et al., Development and validation of the cancer fatigue scale: a brief, three-dimensional, self-rating scale for assessment of fatigue in cancer patients. J Pain Symptom Manage, 2000. 19(1): p. 5-14
Timepoint [5] 370763 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [6] 370977 0
Physical Activity participation:
The Active Australia questionnaire will be used to determine self-reported activity levels . Participants will be requested to include any exercise performed in the previous week in their response to the questionnaire. The survey measures frequency, intensity and duration of incidental and/or intentional physical activity in the week prior to the time of testing. The total time spent in each activity will be multiplied by an intensity value and used to calculate participants’ weekly physical activity in MET.min-1 . This survey is valid and reliable and has previously been used to measure changes in physical activity in chronic disease populations.

Australian Institute of Health and Welfare, The Active Australia Survey: a guide and manual for implementation, analysis and reporting. 2003, AIHW: Canberra.

Brown, W.J., et al., Reliability and validity of a modified self-administered version of the Active Australia physical activity survey in a sample of mid-age women. Aust N Z J Public Health, 2008. 32(6): p. 535-41
Timepoint [6] 370977 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [7] 370978 0
Self efficacy for Exercise
The Exercise Confidence Survey will be used to determine participants perceived self-efficacy to undertake and adhere to an exercise program. This survey asks how confident a person is to continue to exercise despite common barriers such as fatigue, depression, and other life stresses.

Sallis, J.F., et al., The development of self-efficacy scales for healthrelated diet and exercise behaviors. Health Education Research, 1988. 3(3): p. 283-292
Timepoint [7] 370978 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [8] 370979 0
Self-Reported Dietary Intake:
The CSIRO Healthy Diet Score survey is an online extension of the Short Food Survey which was developed by CSIRO and the University of South Australia. The Short Food Survey is a series of short questions which are purposefully compiled to allow for the calculation of a Dietary Guideline Index score. The Short Food Survey has been validated in a sample of Australian adults and been shown to provide a valid estimate of overall diet quality. The online Healthy Diet score comprises 61 questions about the sorts of foods people typically eat, takes approximately 10 minutes to complete, and provides an emailed outcome score and report to the lead investigator. Personal information including gender, year of birth, state or residence, ethnicity, occupation, weight and height is collected about the study participant in order to compile the report that compares results against national averages. Data is stored according to Australian Privacy standards. Privacy information about the survey can be found at: https://my.totalwellbeingdiet.com/privacy_policy.html

Hendrie, G.A., M.A. Rebuli, and R.K. Golley, Reliability and relative validity of a diet index score for adults derived from a self-reported short food survey. Nutr Diet, 2017. 74(3): p. 291-297.


Hendrie, G.A., E. Viner Smith, and R.K. Golley, The reliability and relative validity of a diet index score for 4-11-year-old children derived from a parent-reported short food survey. Public Health Nutr, 2014. 17(7): p. 1486-97.
33. Golley, R.K., G.A. Hendrie, and S.A. McNaughton, Scores on the dietary guideline index for children and adolescents are associated with nutrient intake and socio-economic position but not adiposity. J Nutr, 2011. 141(7): p. 1340-7
Timepoint [8] 370979 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [9] 370980 0
Cardio-vascular measures:
Brachial blood pressure
Will be measured in duplicate by automated oscillometric blood pressure device using standardised operating procedures (see below for detail) developed for the study and according to recommended techniques after a minimum of five minutes of seated rest.

Equipment required:
• Automated oscillometric BP device, and stethoscope, if required.

Procedure (Whelton, 2018):
• Advise participant in advance that they should not to consume caffeine, exercise, or to
smoke minimum of 30 minutes prior to assessment
• Advise participant to have an empty bladder
• Ensure the participant has minimum 5 minutes seated rest prior to measurement.
• For an initial BP measurement, take BP on both arms and use the arm with highest
pressure for subsequent readings.
• Prior to measure, advise the client to relax, not speak or laugh (as this will cause the
BP to rise), and be seated on a chair with feet flat on the ground, back supported.
• The arm used for measurement should be free from constrictive clothing so that the
cuff can be wrapped around the arm. Do not apply cuff over thick clothing. The sleeve
should not be rolled up such that it has a tourniquet effect above the blood pressure
cuff.
• Ensure the participants arm supported to level of right atrium (mid sternum).
• Appropriate cuff size should be measured for the client. Cuff bladder length should be
at least 80% and width 40% of the mid- upper arm.
• Take the BP measure.
• Wait minimum 2 minutes, and repeat (results should be averaged)


Common errors that investigators will be aware of during BP measurement
• Cuff placed over clothing
• Worn out or incorrect cuff size for client
• Inaccurate sphygmomanometer (not serviced regularly or calibrated correctly)
• Arm is elevated above heart level
• Participant not rested before measurement
• Participant talking during measurement

References:
Whelton, P.K., et al., 2017. Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, 2018. 71(19): p. e127-e248.

Pickering, T.G., et al., Recommendations for blood pressure measurement in humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Hypertension, 2005. 45(1): p. 142-61.
Timepoint [9] 370980 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [10] 370981 0
Cardio-vascular measures:
Oxygen Saturation
Will be measured by pulse oximeter according to manufacturers instructions after at least five minutes of seated rest.
Timepoint [10] 370981 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [11] 370982 0
Body Composition Measures:
Height
Will be measured by stadiometer in bare feet according to standardised operating procedures developed for the study,.
Timepoint [11] 370982 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [12] 370983 0
Body Composition Measures:
Weight
Will be measured by electronic scales in bare feet with minimal clothing and heavy items removed from pockets according to standardised operating procedures developed for the study,.
Timepoint [12] 370983 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [13] 370984 0
Body Composition measures:
Body Mass Index
Body mass index (BMI) is a simple and easy to obtain measure and have been widely used as indicators of cardiovascular disease (CVD) and mortality risk in large scale population studies. BMI will be calculated from bare foot height and body weight according to standardised operating procedures

van Dis, I., et al., Body mass index and waist circumference predict both 10-year nonfatal and fatal cardiovascular disease risk: study conducted in 20,000 Dutch men and women aged 20-65 years. Eur J Cardiovasc Prev Rehabil, 2009. 16(6): p. 729-34.

Sui, X., et al., Cardiorespiratory fitness and adiposity as mortality predictors in older adults. JAMA, 2007. 298(21): p. 2507-16.
Timepoint [13] 370984 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points
Secondary outcome [14] 371227 0
Cardio-vascular measures:
Heart rate
Will be measured by pulse oximeter according to manufacturers instructions after at least five minutes of seated rest.
Timepoint [14] 371227 0
Home Exercise Group and Usual Care Group
Baseline and (post 8 week intervention) Follow up time points

Eligibility
Key inclusion criteria
Inclusion:
Individuals aged over 18 years who:
• Are in primary or adjuvant treatment (treatment is defined as chemotherapy, radiation, or are post uncomplicated sub-total colectomy and/or colostomy surgery); OR
• Are maximum 6 months post-treatment for Stage I to III colorectal cancer;
• Are not regularly active (defined as achieving less than 60 mins/week moderate-intensity physical activity or less than 20 mins vigorous physical activity);
• Are medically stable with local (non-metastasised) colorectal cancers;
• Can walk unassisted;
• Have medical clearance to engage in individualised physical activity;
• Are able to read and write in English;
• Have access to a smart phone, tablet, or computer with internet access; and
• Are available to attend a maximum of five sessions at an Exercise Physiology Clinic closest to their home.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include:
• Any contraindication to regular, unsupervised physical activity (a contraindication to exercise may include unstable cardiovascular, metabolic, renal, musculoskeletal, neurological, or pulmonary conditions);
• Total colectomy or ileostomy
• History of other primary cancer
• Any cognitive impairment or intellectual disability that prevents them from providing informed voluntary consent to participate.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This feasibility study is non-randomised and thus this is N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative home exercise group versus usual care group data will be assessed for changes in health-related variables and behaviours over time via mixed methods linear regression (ANOVA) using a completed and intention to treat analysis. Where assumptions of linear regression are violated, data will be analysed using nonparametric analysis via ordinal logistic regression.

Combined outcome data for the intervention group will be analysed against baseline data using mixed methods regression corrected for repeated measures with potential contributing variables such as age, gender, co-morbidities, medications, self-reported activity participation, number of successful telehealth (video chat) and text supports will be included in the analysis as co-variates.

Qualitative data will be obtained from participants by interviews and/or discussion groups. Thematic analysis of the de-identified data will be conducted using NVivo and two researchers will be used to independently code the data. Data analysis will identify common themes and the results may help shape future recommendations and protocols for home exercise in people with bowel cancer.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
27/09/2019
Actual
Date of last data collection
Anticipated
29/11/2019
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 26573 0
7250 - Launceston
Recruitment postcode(s) [2] 26574 0
7310 - Devonport
Recruitment postcode(s) [3] 26575 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 302861 0
Charities/Societies/Foundations
Name [1] 302861 0
Cancer Council Tasmania
Country [1] 302861 0
Australia
Primary sponsor type
University
Name
The University of Tasmania
Address
Locked Bag 1322
Launceston Tasmania 7250
Country
Australia
Secondary sponsor category [1] 302813 0
None
Name [1] 302813 0
Address [1] 302813 0
Country [1] 302813 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303435 0
The Tasmanian Scientific Research Advisory Committee
Ethics committee address [1] 303435 0
Correspondence via:
Office of Research Services
301 Sandy Bay Road, Sandy Bay 7000
Private Bag 1 Hobart TAS 7001
University of Tasmania
Ethics committee country [1] 303435 0
Australia
Date submitted for ethics approval [1] 303435 0
24/06/2019
Approval date [1] 303435 0
Ethics approval number [1] 303435 0
Ethics committee name [2] 303437 0
The Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [2] 303437 0
Office of Research Services
University of Tasmania
301 Sandy Bay Road, Sandy Bay 7000
Private Bag 1 Hobart TAS 7001
Ethics committee country [2] 303437 0
Australia
Date submitted for ethics approval [2] 303437 0
24/06/2019
Approval date [2] 303437 0
Ethics approval number [2] 303437 0

Summary
Brief summary
In Tasmania, bowel cancer is the second most commonly diagnosed type of cancer. Appropriately prescribed exercise during cancer treatment is recommended as an important component of cancer care, but few people take up exercise during their treatment. Often the reasons given for not exercising during cancer treatment are access to exercise experts and affordability. This study will explore the effectiveness of exercise counselling and prescription delivered by an Accredited Exercise Physiologist using app-based technology in people with bowel cancer

Who is it for?
The study is adults over 18 years who are in primary or adjuvant therapy for localised (non-metastasised) bowel cancer (chemo, radiation or post colostomy surgery). Inclusion criteria includes people who are a maximum of 6 months post treatment for stage I to III colorectal cancer.

Study details:
Participants will volunteer for the Home Exercise (intervention) group or the Usual Care (control) group. The Usual Care group will receive standard care as directed by their general practitioner and/ or oncologist.. The Home Exercise group will be involved in an unsupervised home exercise program with 4 x fortnightly education sessions around positive lifestyle changes during treatment for bowel cancer. The program will be delivered via an app using a video conferencing feature. It will cover exercising and eating recommendations for bowel cancer as well as managing stress. The intervention will run for 8 weeks and involve questionnaires and vital sign measurements (heart rate, oxygen saturation, BMI).

What do we expect will happen?
We expect that participants in the Home Exercise group will improve their understanding of the importance of regular exercise in managing the ongoing health effects of cancer and its’ treatments. After 8 weeks of structured and individualised exercise, we expect participants in the Home Exercise group will have improved quality of life, increased strength and aerobic fitness and be more confident in the ongoing self-management of their health, compared to the Usual Care group.
Trial website
N/A
Trial related presentations / publications
None yet
Public notes

Contacts
Principal investigator
Name 93662 0
Dr Sibella Hardcastle
Address 93662 0
The University of Tasmania
Locked Bag 1322
Launceston Tasmania 7250
Country 93662 0
Australia
Phone 93662 0
61 3 6324 5406
Fax 93662 0
Email 93662 0
[email protected]
Contact person for public queries
Name 93663 0
Sibella Hardcastle
Address 93663 0
The University of Tasmania
Locked Bag 1322
Launceston Tasmania 7250
Country 93663 0
Australia
Phone 93663 0
+61 3 6324 5406
Fax 93663 0
Email 93663 0
[email protected]
Contact person for scientific queries
Name 93664 0
Sibella Hardcastle
Address 93664 0
The University of Tasmania
Locked Bag 1322
Launceston Tasmania 7250
Country 93664 0
Australia
Phone 93664 0
+61 3 6324 5406
Fax 93664 0
Email 93664 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?
De-identified Group results pre- and post-intervention for:
- participant demographics
- quality of life (cancer specific QLQ-CR-30, and QLQ-CR-29)
- self reported physical activity
- Self efficacy for exercise
- Exercise test results (hand grip, 30 second sit-to-stand, 6 minute walk test)
- Outcome themes of qualitative discussion group questions
When will data be available (start and end dates)?
After study completion (estimated May 2020) up until 5 years after publication of study data.
Available to whom?
Data will be available on a case by case basis determined by the lead researcher
Available for what types of analyses?
meta analysis and systematic review
How or where can data be obtained?
Email to lead researcher: [email protected]


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.