Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001159640
Ethics application status
Approved
Date submitted
29/09/2014
Date registered
31/10/2014
Date last updated
8/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of older adults with head and neck cancer: the Waikato protocol
Scientific title
Impact of using a geriatric assessment screening tool on multidisciplinary management of older adults with head and neck cancer
Secondary ID [1] 285372 0
Nil
Universal Trial Number (UTN)
U1111-1161-9750
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and neck cancer 293103 0
Condition category
Condition code
Cancer 293377 293377 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients aged over 65 years attending for specialist assessment at Waikato Hospital regarding their head and neck cancer will, in a new initiative, be assessed using the Geriatric-8 (G8) screening tool. This takes only a few minutes and a nurse will ask questions on one occasion about 8 aspects of the patient's health (including appetite, weight loss, mobility, medications and mental functioning). The patient's case will subsequently be presented at the Head and Neck Multidisciplinary Meeting (MDM) for a management decision without the G8 score being disclosed. All patients with potentially curable disease whom either the MDM and/or the G8 screening tool has classified as ‘vulnerable’ will be referred for a comprehensive geriatric assessment (CGA), consisting of a consultation with a specialist geriatric physician. Patients classified as ‘unfit’ by the MDM will be offered palliative treatment or symptomatic care (or a CGA if classified as ‘fit’ on the G8 tool).
Intervention code [1] 290380 0
Early detection / Screening
Comparator / control treatment
Assessment and recommendation for management by the MDM for all patients (without the G8 score being known). The MDM categorises each patient as having potentially curable disease or not; if potentially curable the MDM classifies them as being fit, vulnerable or unfit for curative-intent treatment, and will recommend curative-intent treatment, palliative treatment or supportive care.
Control group
Active

Outcomes
Primary outcome [1] 293205 0
Proportion of patients referred for CGA by the MDM before and after G8 screening results
Timepoint [1] 293205 0
On completion of clinical assessment
Secondary outcome [1] 310590 0
Proportion of potentially-curable patients defined as fit, vulnerable (needing CGA) and unfit to receive curative-intent treatment as defined by the MDM and by subsequent CGA (if undertaken)
Timepoint [1] 310590 0
On completion of clinical assessment
Secondary outcome [2] 310591 0
Proportions of patients recommended to receive curative-intent treatment, palliative treatment or supportive care after MDM assessment and by subsequent CGA (if undertaken)
Timepoint [2] 310591 0
On completion of clinical assessment
Secondary outcome [3] 310592 0
G8 scores of the fit, vulnerable and unfit groups after assessment (by MDM +/- CGA)
Timepoint [3] 310592 0
On completion of clinical assessment
Secondary outcome [4] 310593 0
Proportion of patients who successfully undergo curative-intent treatment in the groups recommended for that by MDM assessment or after CGA, as defined by completion of the recommended course of treatment (which may involve surgery and/or radiation and/or chemotherapy).
Timepoint [4] 310593 0
On completion of clinical treatment

Eligibility
Key inclusion criteria
Patients aged over 65 years of age, with head and neck carcinoma (both cutaneous and mucosal)
Minimum age
66 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not able to complete the G8 screening with the assistance of nursing staff

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
Descriptive statistics will be used to detail patient characteristics, G8 scores, MDM and CGA categorisation and treatments received. Comparison of endpoints expressed as proportions will be assessed using Fisher’s exact test (for binary outcomes) or Chi-square analysis for >2 categorical outcomes. This is a pilot study and no sample size calculations have been performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/10/2014
Date of last participant enrolment
Anticipated
Actual
30/07/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
35
Recruitment outside Australia
Country [1] 6370 0
New Zealand
State/province [1] 6370 0
Waikato

Funding & Sponsors
Funding source category [1] 289984 0
Self funded/Unfunded
Name [1] 289984 0
Country [1] 289984 0
Primary sponsor type
Hospital
Name
Waikato District Health Board
Address
Private Bag 3200
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 288669 0
None
Name [1] 288669 0
Address [1] 288669 0
Country [1] 288669 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291728 0
Health and Disability Ethics Committee
Ethics committee address [1] 291728 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 291728 0
New Zealand
Date submitted for ethics approval [1] 291728 0
Approval date [1] 291728 0
23/09/2014
Ethics approval number [1] 291728 0

Summary
Brief summary
Older patients with head and neck cancer may not tolerate the treatments given with the intent to cure their disease as well as younger adults, which may compromise their outcome. Comprehensive assessment by a geriatrician to assess the fitness of older adults for such treatment is recommended but this cannot be provided with existing resources. We are introducing a screening questionnaire to assess which patients may benefit from a geriatric assessment before a final treatment recommendation is made. In this study we will assess how the information provided by the screening questionnaire changes the proportion of patients who are referred for geriatric assessment, and the resulting changes in patient management and short-term outcomes.
Trial website
Trial related presentations / publications
Public notes
Formal ethical review is not required under New Zealand Health and Disability Ethics Committee Standard Operating Procedures.

Contacts
Principal investigator
Name 51558 0
Dr Matthew Neve
Address 51558 0
Oncology Department
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 51558 0
New Zealand
Phone 51558 0
+64 7 839 8899
Fax 51558 0
+64 7 839 8778
Email 51558 0
[email protected]
Contact person for public queries
Name 51559 0
Dr Matthew Neve
Address 51559 0
Oncology Department
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 51559 0
New Zealand
Phone 51559 0
+64 7 839 8899
Fax 51559 0
+64 7 839 8778
Email 51559 0
[email protected]
Contact person for scientific queries
Name 51560 0
Dr Matthew Neve
Address 51560 0
Oncology Department
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 51560 0
New Zealand
Phone 51560 0
+64 7 839 8899
Fax 51560 0
+64 7 839 8778
Email 51560 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseImpact of geriatric assessment on the management of older adults with head and neck cancer: A pilot study.2016https://dx.doi.org/10.1016/j.jgo.2016.05.006
N.B. These documents automatically identified may not have been verified by the study sponsor.