Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
http://www.slhd.nsw.gov.au/concord/ethics/
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
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.
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
[email protected]
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
[email protected]
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
[email protected]

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.