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Trial registered on ANZCTR
Registration number
ACTRN12624000931572
Ethics application status
Approved
Date submitted
19/07/2024
Date registered
1/08/2024
Date last updated
1/08/2024
Date data sharing statement initially provided
1/08/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Pre-operative video about bowel function and supportive care in colorectal cancer: feasibility study
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Scientific title
Pre-operative video about bowel function and supportive care in colorectal cancer: feasibility study
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Secondary ID [1]
312565
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer
334467
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Condition category
Condition code
Cancer
331087
331087
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Public Health
331158
331158
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Non-randomised, single arm study
Educational video series developed by the investigators will be used in the intervention. There are 4 videos with estimated duration 6-10 minutes each included in the series. The videos cover the topics on bowel and general health, bowel, bladder and sexual function, pelvic floor muscle exercise. This is a participant's self-administered intervention. Mode of delivery: electronic device; content will be delivered by health care professional's illustration and animation on screen. Number of times: once. Location: participant's home. Participants will be asked to view the video series over the course of a 1-2 weeks depending on the time of referral. The participants will be assigned to complete the video series 5 days before the scheduled surgery date. Participants will access the videos via a link emailed to the participants. Study specific questionnaires will be used to monitor adherence to the intervention.
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Intervention code [1]
329080
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Rehabilitation
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Intervention code [2]
329128
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Lifestyle
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Intervention code [3]
329129
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Behaviour
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Feasibility
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Assessment method [1]
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Number of people referred to the study. Recruitment and completion rate.
Study specific questionnaires will be used to to gather data and study records audit will be performed for outcome measures.
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Timepoint [1]
338858
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Upon conclusion of the study
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Secondary outcome [1]
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Satisfaction level
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Assessment method [1]
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Study specific satisfaction survey
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Timepoint [1]
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End of intervention
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Secondary outcome [2]
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Participants' knowledge
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Assessment method [2]
437698
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Study specific quiz
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Timepoint [2]
437698
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End of intervention
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Secondary outcome [3]
437908
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Drop out rate
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Assessment method [3]
437908
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Study records audit
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Timepoint [3]
437908
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Upon conclusion of study
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Eligibility
Key inclusion criteria
• Pre-operative clinical staging confirmed stage I-III colorectal cancer, (CRC) or limited IV colorectal cancer (e.g. limited liver metastases planned for resection)
• Elective surgery for colorectal cancer +/- temporary stoma scheduled >7 days after the time of referral to the study so video viewing can be completed at least 5 days before the scheduled surgery date
• At least 18 years of age
• Able to comprehend written and spoken English
• Willing to provide informed consent
• Willing to participate and comply with the study requirements
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• unable to comprehend information due to cognitive difficulties
• Surgical resection that will require a permanent stoma
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
21/03/2023
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Date of last participant enrolment
Anticipated
20/12/2024
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Actual
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Date of last data collection
Anticipated
31/01/2025
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Actual
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Sample size
Target
25
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Accrual to date
22
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
316993
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Hospital
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Name [1]
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Concord Repatriation General Hospital
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Address [1]
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Country [1]
316993
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Australia
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Primary sponsor type
Government body
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Name
Sydney Local Health District (SLHD)
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Address
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Country
Australia
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Secondary sponsor category [1]
319241
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None
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Name [1]
319241
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Address [1]
319241
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Country [1]
319241
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315748
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Sydney Local Health District HREC – Concord Repatriation General Hospital
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Ethics committee address [1]
315748
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http://www.slhd.nsw.gov.au/concord/ethics/
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Ethics committee country [1]
315748
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Australia
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Date submitted for ethics approval [1]
315748
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10/06/2022
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Approval date [1]
315748
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10/08/2022
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Ethics approval number [1]
315748
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Summary
Brief summary
The purpose of the study is to determine the feasibility of pre-operative educational videos on bowel cancer related functional recovery. Who is it for? You may be eligible for this study if you are an adult who has had pre-operative clinical staging confirming stage I-III or limited stage IV colorectal cancer. In addition, you should have elective surgery for cancer resection +/- temporary stoma scheduled >7 days after the time of referral to the study. Study details At least 5 days before your scheduled surgical procedure, participants will be asked to view a series of 4 videos with estimated duration 6-10 minutes each, covering the topics of bowel and general health, bowel, bladder and sexual function, and pelvic floor muscle exercise. Following this, participants will be asked to complete satisfaction and knowledge measures. It is hoped that findings from this study will help investigators develop tools to aid patient understanding of bowel issues associated with surgery and provide coping strategies for the potential side effects from surgery and treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Janette Vardy
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Address
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Concord Cancer Centre Concord Repatriation & General Hospital Hospital Rd Concord, NSW, 2139
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Country
135686
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Australia
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Phone
135686
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+61 2 9767 5969
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Fax
135686
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Email
135686
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[email protected]
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Contact person for public queries
Name
135687
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Janette Vardy
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Address
135687
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Concord Cancer Centre Concord Repatriation & General Hospital Hospital Rd Concord, NSW, 2139
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Country
135687
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Australia
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Phone
135687
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+61 2 9767 5000
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Fax
135687
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Email
135687
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[email protected]
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Contact person for scientific queries
Name
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Janette Vardy
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Address
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Concord Cancer Centre Concord Repatriation & General Hospital Hospital Rd Concord, NSW, 2139
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Country
135688
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Australia
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Phone
135688
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+61 2 9767 5000
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Fax
135688
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Email
135688
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Under the SLHD ethics committee privacy act, individual participant data will not be disclosed and shared.
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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.
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