Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001023347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
22/07/2026
Date registered
Help: Date registered
19/08/2026
Date last updated
Help: Date last updated
19/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
19/08/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Functional and quality of life outcomes for head and neck cancer patients following jaw reconstruction
Scientific title
Functional and quality of life outcomes for head and neck cancer patients following jaw reconstruction
Additional trial identifiers [1] 317779 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Head and Neck Cancer 342682 0
Jaw Reconstruction 343109 0
Condition category
Condition code
Cancer 338819 338819 0 0
Head and neck
Surgery 338820 338820 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of the intervention or exposure
All patients aged >18 years who are to undergo jaw reconstruction of the mandible or maxilla (with or without Virtual Surgical Planning (VSP)) from all participating sites will be invited to participate in the prospective cohort study. This study is for patients undergoing jaw reconstruction, this surgery is independent of the study and therefore eligibility is not dependent on enrolling in the study.

Patients will be asked to complete a short survey assessing Quality of Life (QoL) and functional outcomes at baseline (prior to reconstructive surgery) and at the following intervals post-operatively, measured from the date of surgery: 3-months, 6-months, 12-months, then every 12-months up to 10 years. These questionnaires can be done in person, or posted out to the participant and returned. They can also be done online. These questionnaires will take approximately 20 minutes.

If in person, the study coordinators will meet participants at their standing appointments and provide the questionnaire.

For participants at Chris O'Brien Lifehouse only, two measures will be administered by trained clinicians (speech pathologists) to measure i) speech intelligibility and ii) swallowing function. Intelligibility of speech will be assessed by a trained speech pathologist at the Chris O’Brien Lifehouse, either face-to-face or via internet telehealth systems. PArticipants will read a passage of text and clinicians will analyse it. This will take approximately 5 minutes.

For swallowing function, the Functional Intake Oral Score (FOIS) is a clinician-administered score that will be determined by a trained speech pathologist to measure functional oral intake of food and liquids. This will take approximately 5 minutes.
Intervention code [1] 334624 0
Not applicable
Description of the comparator or control
No control group
Control group
Active

Outcomes
Primary outcome [1] 346033 0
Quality of life
Timepoint [1] 346033 0
baseline (pre-surgery), 3-monthly, 6-monthly, 12-monthly, then every 12-months up to 10 years post-operatively
Secondary outcome [1] 464384 0
Functional outcome- Speech intelligibility (Only at Chris O'Brien Lifehouse)
Timepoint [1] 464384 0
baseline (pre-surgery), 3-monthly, 6-monthly, 12-monthly, then every 12-months up to 10 years post-operatively
Secondary outcome [2] 465884 0
Functional outcome- swallowing function (Only at Chris O'Brien Lifehouse)
Timepoint [2] 465884 0
baseline (pre-surgery), 3-monthly, 6-monthly, 12-monthly, then every 12-months up to 10 years post-operatively

Eligibility
Key inclusion criteria
- Underwent or planning to undergo mandibular or maxillary reconstruction using virtual surgical planning (VSP) or reconstruction without VSP (traditional planning) at all participating sites
- Sufficient English language skills to complete survey, or a nominated person who can assist in completing the survey
- Cognitively able to provide informed consent, or supported by a family member, authorised representative or another carer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Nil

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/12/2020
Date of last participant enrolment
Anticipated
3/12/2030
Actual
Date of last data collection
Anticipated
3/12/2040
Actual
Sample size
Target
1000
Accrual to date
686
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 29951 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 29952 0
The Canberra Hospital - Garran
Recruitment hospital [3] 29953 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 46315 0
4215 - Southport
Recruitment postcode(s) [2] 46316 0
2605 - Garran
Recruitment postcode(s) [3] 46317 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 322323 0
Hospital
Name [1] 322323 0
Chris O'Brien Lifehouse
Country [1] 322323 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
Country
Australia
Secondary sponsor category [1] 325241 0
None
Name [1] 325241 0
Address [1] 325241 0
Country [1] 325241 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320827 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 320827 0
Ethics committee country [1] 320827 0
Australia
Date submitted for ethics approval [1] 320827 0
Approval date [1] 320827 0
02/12/2020
Ethics approval number [1] 320827 0

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

Contacts
Principal investigator
Name 151766 0
Prof Jonathan Clark
Address 151766 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 151766 0
Australia
Phone 151766 0
+61 2 8514 0972
Fax 151766 0
Email 151766 0
[email protected]
Contact person for public queries
Name 151767 0
Dr Masako Dunn
Address 151767 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 151767 0
Australia
Phone 151767 0
+6128514 0411
Fax 151767 0
Email 151767 0
[email protected]
Contact person for scientific queries
Name 151768 0
Dr Masako Dunn
Address 151768 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 151768 0
Australia
Phone 151768 0
+6128514 0411
Fax 151768 0
Email 151768 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.