Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000774628p
Ethics application status
Not yet submitted
Date submitted
11/07/2023
Date registered
17/07/2023
Date last updated
17/07/2023
Date data sharing statement initially provided
17/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
App based Pelvic Floor Muscle Training for Changing Outcomes After Low Anterior resection (COALA)
Scientific title
COALA Trial: Changing Outcomes After Low Anterior resection in colorectal cancer by anal sphincter prehabilitation prior to reversal of ileostomy – a pragmatic trial (COALA-2)
Secondary ID [1] 310098 0
None
Universal Trial Number (UTN)
Trial acronym
COALA-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low anterior resection syndrome 330661 0
Rectal cancer 330662 0
Incontinence 330663 0
Condition category
Condition code
Surgery 327476 327476 0 0
Other surgery
Cancer 327535 327535 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 327536 327536 0 0
Health service research
Physical Medicine / Rehabilitation 327537 327537 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients not recruited into COALA-1 will be included into COALA-2.
At centers where physiotherapists are unavailable, all patients will be directly recruited into COALA-2.
Electronic phone application based based physiotherapy intervention where patients download an electronic application on their phone with a preset pelvic floor exercise regimen and built in reminders to perform these exercises. Patients will be asked to complete these exercises three times a day for at least 12 weeks. This will begin at least 1 week before ileostomy reversal, but ideally 4-6 weeks prior to ileostomy reversal if they are able to be recruited in time.
Adherence will be monitored through in app function which records exercise engagement and duration.
Information about lifestyle modification, theory behind pelvic floor exercises, and how to perform these exercises will be available on the application in written, pictorial and video format.


An example of the exercises prescribed in would be as follows:
These exercises are a set prescription of repetitions
Initially, muscle identification exercises
- Position: Sitting forward in a chair, with knees and legs apart
- Exercise: Squeeze pelvic floor and identify pelvic floor lift
Rest 4 seconds, then repeat 3-4 times
This will be repeated 3 times/day

Then, an ongoing regime of this exercise will be prescribed as follows:
Exercise 1- Hold 5-10sec, rest5-10sec ( pending on patient's ability)/5reps increase to 10 reps/3xday
Exercise 2- Hold/Rest/ 10reps increase to 20 reps/3xday
Follow exercise 3, 4 and daily application as above

The duration of these exercises is variable as this depends on the repetitions rather than a specific time.
Intervention code [1] 326497 0
Treatment: Other
Comparator / control treatment
Standard care following ileostomy reversal which may include dietary and lifestyle modification and use of medications but not any form of pelvic floor physiotherapy
Control group
Active

Outcomes
Primary outcome [1] 335344 0
Incidence of low anterior resection syndrome via validated Low Anterior Resection Score (LARS) developed and validated by Emmertson et al in 2012

Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21. PMID: 22504191.
Timepoint [1] 335344 0
1, 6 and 12 months after closure of loop ileostomy
Secondary outcome [1] 424014 0
Quality of life via eQ5D score
Timepoint [1] 424014 0
1, 6 and 12 months after closure of loop ileostomy
Secondary outcome [2] 424015 0
Compliance with pelvic floor muscle training - assessed using app based recording of exercises
Timepoint [2] 424015 0
1, 6 and 12 months after closure of loop ileostomy

Eligibility
Key inclusion criteria
The inclusion criteria for this study are:
Adults aged 18 years and older, AND
Have undergone a low anterior resection and received a diverting ileostomy, AND
Who will have their ileostomies reversed in at least 1 weeks' time
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Are unable to provide informed consent, OR
Are unable to perform the pelvic floor rehabilitation program
Are unable to use or access the app due for any reason

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruiter will be able to obtain randomisation after inputting patient into RedCap and assist patient in downloading the phone based application, or continue with standard care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
POLARS score will be used to stratify patients into 3 categories - Risk of major LARS, Minor LARS and No LARS.
Permuted block randomisation will then be used via RedCap.

POLARS score is a nomogram designed to predict post operative LARS score by Battersby et al in 2018.

Battersby NJ, Bouliotis G, Emmertsen KJ, Juul T, Glynne-Jones R, Branagan G, Christensen P, Laurberg S, Moran BJ; UK and Danish LARS Study Groups. Development and external validation of a nomogram and online tool to predict bowel dysfunction following restorative rectal cancer resection: the POLARS score. Gut. 2018 Apr;67(4):688-696. doi: 10.1136/gutjnl-2016-312695. Epub 2017 Jan 23. PMID: 28115491.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features

Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Categorical data will be expressed as frequency (percentage). Univariate and multivariate categorical variables will be compared using the Chi-square test and logistic regression, respectively. Continuous variables will be expressed as mean (standard deviation) and median (interquartile range) depending on the normality. Normality will be assessed using the D’Agostino-Pearson test. Parametric and non-parametric continuous variables will be compared using the Student’s T-test and Mann-Whitney U-test, respectively. Participants will be compared over time using the Paired Student’s T-test for parametric data and the Wilcoxon Signed Rank test for non-parametric data. Subgroup analyses will be performed for risk groups, gender, neoadjuvant therapy and country of recruitment. P-values <0.05 are considered statistically significant. Statistical analysis will be performed using GraphPad Prism v9.0 (GraphPad Software Inc., San Diego, CA, USA) and StataBE v17.0 (StataCorp, College Station, TX, USA).
Missing data (provided data are ‘missing completely at random’), will be addressed by performing primary analysis with only observed outcomes (complete case analysis). Loss to follow-up will be addressed by intention-to-treat analysis with simple mean/median imputation.
The free-text responses in the acceptability intervention survey will be thematically analysed using NVivo V.10. Data will be presented as a combination of themes and direct quotations (of non-identifying data) only.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/08/2023
Actual
Date of last participant enrolment
Anticipated
25/11/2024
Actual
Date of last data collection
Anticipated
25/11/2025
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 25098 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 25099 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [3] 25100 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [4] 25101 0
The Alfred - Melbourne
Recruitment hospital [5] 25102 0
Eastern Health - Box Hill
Recruitment hospital [6] 25103 0
Epworth Cliveden - Melbourne East
Recruitment hospital [7] 25104 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [8] 25105 0
Melbourne Private Hospital - Parkville
Recruitment hospital [9] 25106 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [10] 25107 0
Royal Hobart Hospital - Hobart
Recruitment hospital [11] 25108 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [12] 25109 0
Knox Private Hospital - Wantirna
Recruitment hospital [13] 25110 0
The Northern Hospital - Epping
Recruitment hospital [14] 25111 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [15] 25112 0
St George's Health Service - Kew
Recruitment hospital [16] 25113 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 40768 0
3084 - Heidelberg
Recruitment postcode(s) [2] 40769 0
3081 - Heidelberg West
Recruitment postcode(s) [3] 40770 0
3004 - Melbourne
Recruitment postcode(s) [4] 40771 0
3128 - Box Hill
Recruitment postcode(s) [5] 40772 0
3002 - Melbourne East
Recruitment postcode(s) [6] 40773 0
3052 - Parkville
Recruitment postcode(s) [7] 40774 0
7000 - Hobart
Recruitment postcode(s) [8] 40775 0
5000 - Adelaide
Recruitment postcode(s) [9] 40776 0
3152 - Wantirna
Recruitment postcode(s) [10] 40777 0
3076 - Epping
Recruitment postcode(s) [11] 40778 0
6009 - Nedlands
Recruitment postcode(s) [12] 40779 0
3101 - Kew
Recruitment postcode(s) [13] 40780 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 25634 0
United Kingdom
State/province [1] 25634 0
London

Funding & Sponsors
Funding source category [1] 314261 0
Other
Name [1] 314261 0
Austin Health
Country [1] 314261 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
3084 Heidelberg
Melbourne, Victoria
Australia
Country
Australia
Secondary sponsor category [1] 316200 0
None
Name [1] 316200 0
Address [1] 316200 0
Country [1] 316200 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313380 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 313380 0
Ethics committee country [1] 313380 0
Australia
Date submitted for ethics approval [1] 313380 0
21/08/2023
Approval date [1] 313380 0
Ethics approval number [1] 313380 0

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

Contacts
Principal investigator
Name 127946 0
Dr Helen Mohan
Address 127946 0
Austin Health
145 Studley Road
3084 Heidelberg
Melbourne, Victoria
Country 127946 0
Australia
Phone 127946 0
+61 411101743
Fax 127946 0
Email 127946 0
helen.mohan@austin.org.au
Contact person for public queries
Name 127947 0
Hwa Ian Ong
Address 127947 0
Austin Health
145 Studley Road
3084 Heidelberg
Melbourne, Victoria
Country 127947 0
Australia
Phone 127947 0
+61 410187877
Fax 127947 0
Email 127947 0
ian.ong@austin.org.au
Contact person for scientific queries
Name 127948 0
Hwa Ian Ong
Address 127948 0
Austin Health
145 Studley Road
3084 Heidelberg
Melbourne, Victoria
Country 127948 0
Australia
Phone 127948 0
+61 410187877
Fax 127948 0
Email 127948 0
ian.ong@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified patient data will be shared, including baseline characteristics and outcome scores
When will data be available (start and end dates)?
Data will be available upon completion of the study, anticipated Nov 2025 and it will be available for 5 years after publication
Available to whom?
This will be assessed on a case by case basis with advice from the local Ethics committee
Available for what types of analyses?
Meta-analyses and systematic reviews
How or where can data be obtained?
Access will be subject to approval by principal investigator, who can be contacted through email address helen.mohan@austin.org.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19659Study protocol    To be published
19660Informed consent form    Will be uploaded once it has been approved through... [More Details]
19661Clinical study report    To be published
19662Ethical approval    Will be uploaded once obtained



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.