Trial Review

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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
Scientific title
Pre-operative video about bowel function and supportive care in colorectal cancer: feasibility study
Secondary ID [1] 312565 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 334467 0
Condition category
Condition code
Cancer 331087 331087 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 331158 331158 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329080 0
Rehabilitation
Intervention code [2] 329128 0
Lifestyle
Intervention code [3] 329129 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338858 0
Feasibility
Timepoint [1] 338858 0
Upon conclusion of the study
Secondary outcome [1] 437697 0
Satisfaction level
Timepoint [1] 437697 0
End of intervention
Secondary outcome [2] 437698 0
Participants' knowledge
Timepoint [2] 437698 0
End of intervention
Secondary outcome [3] 437908 0
Drop out rate
Timepoint [3] 437908 0
Upon conclusion of study

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• unable to comprehend information due to cognitive difficulties
• Surgical resection that will require a permanent stoma

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)
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/03/2023
Date of last participant enrolment
Anticipated
20/12/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
25
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316993 0
Hospital
Name [1] 316993 0
Concord Repatriation General Hospital
Country [1] 316993 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District (SLHD)
Address
Country
Australia
Secondary sponsor category [1] 319241 0
None
Name [1] 319241 0
Address [1] 319241 0
Country [1] 319241 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315748 0
Sydney Local Health District HREC – Concord Repatriation General Hospital
Ethics committee address [1] 315748 0
Ethics committee country [1] 315748 0
Australia
Date submitted for ethics approval [1] 315748 0
10/06/2022
Approval date [1] 315748 0
10/08/2022
Ethics approval number [1] 315748 0

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

Contacts
Principal investigator
Name 135686 0
Prof Janette Vardy
Address 135686 0
Concord Cancer Centre Concord Repatriation & General Hospital Hospital Rd Concord, NSW, 2139
Country 135686 0
Australia
Phone 135686 0
+61 2 9767 5969
Fax 135686 0
Email 135686 0
janette.vardy@sydney.edu.au
Contact person for public queries
Name 135687 0
Janette Vardy
Address 135687 0
Concord Cancer Centre Concord Repatriation & General Hospital Hospital Rd Concord, NSW, 2139
Country 135687 0
Australia
Phone 135687 0
+61 2 9767 5000
Fax 135687 0
Email 135687 0
janette.vardy@sydney.edu.au
Contact person for scientific queries
Name 135688 0
Janette Vardy
Address 135688 0
Concord Cancer Centre Concord Repatriation & General Hospital Hospital Rd Concord, NSW, 2139
Country 135688 0
Australia
Phone 135688 0
+61 2 9767 5000
Fax 135688 0
Email 135688 0
janette.vardy@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Under the SLHD ethics committee privacy act, individual participant data will not be disclosed and shared.


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.