Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001044314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
30/07/2026
Date registered
Help: Date registered
25/08/2026
Date last updated
Help: Date last updated
25/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
25/08/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising evidence-based perioperative nutrition care in patients undergoing reconstruction surgery for head and neck cancer (HNC)
Scientific title
To assess the feasibility of implementing of a digital, patient-led malnutrition screening tool for patients undergoing reconstruction surgeries for head and neck cancer (HNC)
Additional trial identifiers [1] 318046 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Head and Neck Cancer 343058 0
Jaw Reconstruction 343059 0
Malnutrition 343194 0
Condition category
Condition code
Cancer 339157 339157 0 0
Head and neck
Surgery 339158 339158 0 0
Other surgery
Diet and Nutrition 339280 339280 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is a digital, patient-led malnutrition screening tool for patients undergoing reconstruction surgeries for head and neck cancer (HNC) at Chris O’Brien Lifehouse (COBL).

This study that will have 2 phases. Phase 1 will work with consumer advisory panel members from Chris O'Brien Lifehouse to co-design a digital patient-led malnutrition screening tool in partnership with IT specialists and healthcare professionals. This co-design workshop involves usability testing of the digital screening tool and a focus group to invite feedback on user experience. This phase will focus on the process of screening, including when it is introduced, how patients are asked to complete it and how these requests are worded. Feedback will be used by to refine and finalise the prototype before wider feasibility testing.

Phase 2 will examine the feasibility of implementing the digital patient-led malnutrition screening tool (MST) pre-operatively for patients undergoing reconstruction surgeries for HNC. Usability will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire with Likert scale questions and corresponding scores based on responses. This survey will be conducted online. This questionnaire covers usability areas such as asking users to indicate how they found the system to use and if they needed to learn anything before using the system.

Both phase 1 and 2 will be delivered by Shane McAuliffe, registered dietitian and PhD student.

Phase 1 will be one online or in person focus group expected to be 1-1.5 hours total.
Phase 2 will need to complete a short survey (over the phone or via SMS) followed by testing the tool and the a final online survey. This should all take about 30 minutes.
Intervention code [1] 334934 0
Early detection / Screening
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346401 0
perceived usability of co-designed digital patient-led malnutrition screening tool
Timepoint [1] 346401 0
During the focus group
Primary outcome [2] 346403 0
Examine the feasibility of implementing the digital patient-led malnutrition screening tool pre-operatively for patients undergoing reconstruction surgeries for HNC
Timepoint [2] 346403 0
At the time of testing the tool during phase 2
Primary outcome [3] 346508 0
Examine the feasibility of implementing the digital patient-led malnutrition screening tool pre-operatively for patients undergoing reconstruction surgeries for HNC
Timepoint [3] 346508 0
At the time of testing the tool during phase 2
Secondary outcome [1] 465731 0
Examine the acceptability of implementing the digital patient-led malnutrition screening tool pre-operatively for patients undergoing reconstruction surgeries for HNC
Timepoint [1] 465731 0
At the time of testing the tool during phase 2
Secondary outcome [2] 465732 0
Examine the adoption of implementing the digital patient-led malnutrition screening tool pre-operatively for patients undergoing reconstruction surgeries for HNC
Timepoint [2] 465732 0
At the time of testing during phase 2
Secondary outcome [3] 465733 0
Examine the fidelity of implementing the digital patient-led malnutrition screening tool pre-operatively for patients undergoing reconstruction surgeries for HNC
Timepoint [3] 465733 0
At the time of testing during phase 2
Secondary outcome [4] 466159 0
Examine the fidelity of implementing the digital patient-led malnutrition screening tool pre-operatively for patients undergoing reconstruction surgeries for HNC
Timepoint [4] 466159 0
At the time of testing during phase 2
Secondary outcome [5] 466160 0
Examine the fidelity of implementing the digital patient-led malnutrition screening tool pre-operatively for patients undergoing reconstruction surgeries for HNC
Timepoint [5] 466160 0
At the time of testing during phase 2

Eligibility
Key inclusion criteria
Phase 1: Consumer advisory panel members at COBL will be eligible to participate in the study. Willingness to give informed consent and willingness to participate and comply with the study procedures will be required. We will aim to recruit panel members with lived experience of HNC specifically as part of the sample.

Phase 2: All patients undergoing reconstruction surgery for HNC at COBL will be eligible for the study. Included participants must be >18 years, English-speaking and have access to a mobile device and internet to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Phase 1: Individuals unable/unwilling to provide informed consent for participation, non-English speaking, without access to a mobile device and internet will not be eligible to participate during this phase

Phase 2: All patients <18 years, Individuals unable/unwilling to provide informed consent for participation, non-English speaking and without access to a mobile device and internet will not be eligible to participate during this phase

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/07/2026
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
105
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29927 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 46290 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 322602 0
Hospital
Name [1] 322602 0
Chris O'Brien Lifehouse
Country [1] 322602 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
Country
Australia
Secondary sponsor category [1] 325538 0
None
Name [1] 325538 0
Address [1] 325538 0
Country [1] 325538 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321068 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 321068 0
Ethics committee country [1] 321068 0
Australia
Date submitted for ethics approval [1] 321068 0
23/02/2026
Approval date [1] 321068 0
09/04/2026
Ethics approval number [1] 321068 0

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

Contacts
Principal investigator
Name 152558 0
Mr Shane McAuliffe
Address 152558 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 152558 0
Australia
Phone 152558 0
+61 2 8514 0204
Fax 152558 0
Email 152558 0
[email protected]
Contact person for public queries
Name 152559 0
Shane McAuliffe
Address 152559 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 152559 0
Australia
Phone 152559 0
+61 2 8514 0204
Fax 152559 0
Email 152559 0
[email protected]
Contact person for scientific queries
Name 152560 0
Shane McAuliffe
Address 152560 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 152560 0
Australia
Phone 152560 0
+61 2 8514 0204
Fax 152560 0
Email 152560 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.