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Trial registered on ANZCTR


Trial ID
ACTRN12613000916741
Ethics application status
Approved
Date submitted
24/07/2013
Date registered
19/08/2013
Date last updated
15/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The PACT Study: Psychosocial Assessment, Care and Treatment of patients with urological and head and neck cancers.
Scientific title
Feasibility study of an integrated, patient-centred psychosocial care model for patients with urological and head and neck cancers.
Secondary ID [1] 282738 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urological cancers 289473 0
Head and Neck cancers 289474 0
Condition category
Condition code
Cancer 289789 289789 0 0
Head and neck
Cancer 289790 289790 0 0
Prostate
Cancer 289791 289791 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PACT (Psychosocial Assessment, Care and Treatment) model, targeting patients with head and neck (H&N) or urological cancers at John Hunter Hospital, will be developed as part of this study. This model aims to systematise the approach to screening for distress and responding to that distress in a coordinated manner, including facilitating continuity of care for patients who reside some distance from the acute care setting where their cancer treatment was received.
As part of the newly developed model of care, all inpatient and outpatient urology and H&N cancer patients will be screened at their first diagnostic or treatment visit and at each subsequent follow-up visit, using the Distress Thermometer (DT) and accompanying Problem Checklist, which will inform the development of a care plan to address the issues identified through the screening and second-line inquiry. The care plan will facilitate provision of care tailored to specific needs of patients and promote continuity of care across care settings and providers, including with health care providers (HCPs) in rural and regional areas.
The screening and problem checklist will act as a trigger for frontline staff to inquire about and discuss the cause/s of distress with patients whose distress levels are above the recommended cut-off of 4 out of 10. Training for frontline staff will focus on discussing the cause of the distress, developing an evidence-based psychosocial care plan to address identified concerns, providing information and/or basic counselling or referring patients with significant or persistent distress to the psycho-oncology service, and facilitating continuity of care including linking patients with hospital and community services as required. Training will be delivered in 2.5-3 hour sessions on a quarterly basis throughout the duration of the intervention period. Long-term sustainability of these service changes will be promoted through organisational leadership and management support; engagement of cancer clinician leaders in each unit in the design and evaluation of the service model; and development of a model with the aim of adaptability and flexibility to diversity of locations and patient complexity (e.g. through complex case review and revision of psychosocial care plans and active involvement of clinicians from rural locations in this process). This new model of care is expected to be implemented for a period of 15 months.
Intervention code [1] 287401 0
Rehabilitation
Intervention code [2] 287741 0
Treatment: Other
Comparator / control treatment
Historical data will be collected at the baseline data collection period for those patients who receive care from John Hunter Hospital prior to the introduction of the new care model. This data will pertain to the 12 months preceding their recruitment date.
Control group
Historical

Outcomes
Primary outcome [1] 289870 0
System-wide increase in the proportion of eligible patients who complete distress screening on at least one occasion and have a psychosocial care plan developed which complies with recommended care pathways. This will be assessed via data linkage to patient medical records.
Timepoint [1] 289870 0
Baseline, and at 21 and 30 months after intervention commencement.
Secondary outcome [1] 303432 0
Increase in the proportion of eligible patients who report positive experiences of their cancer care. This will be assessed via a Patient Experiences Survey; a 35-item survey assessing the emotional support, information and education and coordination of care perceived by patients to have been provided to them throughout their treatment period at John Hunter Hospital. All items will be answered on a 5-point Likert-type scale ranging from 1= ‘strongly disagree’ to 5= ‘strongly agree’.
Timepoint [1] 303432 0
Baseline, and at 21 and 30 months after intervention commencement.

Eligibility
Key inclusion criteria
Key patient inclusion criteria are: a) aged 18 years or over, b) diagnosed with a urological cancer or a head and neck (H&N) cancer, and c) receiving inpatient and/or outpatient care at John Hunter Hospital.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key patient exclusion criteria are: a) aged below 18 years, b) not diagnosed with a urological or a head and neck (H&N) cancer, and c) not receiving any inpatient or outpatient care at John Hunter Hospital.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1160 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 7008 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 287509 0
Government body
Name [1] 287509 0
Cancer Institute NSW
Address [1] 287509 0
Australian Technology Park
Level 9, 8 Central Avenue
EVELEIGH NSW 2015
Country [1] 287509 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
High St
UNSW KENSINGTON NSW 2052
Country
Australia
Secondary sponsor category [1] 286248 0
University
Name [1] 286248 0
The University of Newcastle
Address [1] 286248 0
University Drive
CALLAGHAN NSW 2308
Country [1] 286248 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289485 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 289485 0
Hunter New England Research Ethics & Governance Unit
Administration Building
Lookout Road
NEW LAMBTON NSW 2305
Ethics committee country [1] 289485 0
Australia
Date submitted for ethics approval [1] 289485 0
08/06/2012
Approval date [1] 289485 0
26/06/2012
Ethics approval number [1] 289485 0
12/06/20/5.05
Ethics committee name [2] 289487 0
The University of New South Wales Human Research Ethics Committee
Ethics committee address [2] 289487 0
Grants Management Office
Level 3, Rupert Myers Building (South Wing)
UNSW KENSINGTON NSW 2052
Ethics committee country [2] 289487 0
Australia
Date submitted for ethics approval [2] 289487 0
13/09/2012
Approval date [2] 289487 0
27/09/2012
Ethics approval number [2] 289487 0
HC12529

Summary
Brief summary
This study is developing, and evaluating the feasibility, cost and acceptability of, a patient-centred, integrated model of psychosocial care for people receiving treatment for urological or head and neck cancers.
Who is it for?
You will be eligible to join this study if you are aged 18 years or above and have been diagnosed with a urological cancer or a head and neck cancer, for which you are receiving inpatient and/or outpatient care at John Hunter Hospital.
Trial details
All participants in this study will receive treatment, as required, under the PACT (Psychosocial Assessment, Care and Treatment) model. As part of this newly developed model of care, all inpatient and outpatient urology and head and neck cancer patients will be screened at their first diagnostic or treatment visit and at each subsequent follow-up visit, using the Distress Thermometer (DT) and accompanying Problem Checklist. This will be used to develop a care plan to address any issues identified through the screening and second-line inquiry. The care plan will facilitate the provision of care which is tailored to the specific needs of patients, and promote continuity of care across care settings and providers; including with health care providers (HCPs) in rural and regional areas.
Participants will be asked to report experiences of their cancer care at baseline, and at 21 and 30 months after intervention commencement. It is anticipated that implementation of this model will improve continuity of care, increase health care professionals' awareness, confidence, knowledge and skills to discuss and respond to patients' specific concerns, and improve access to specialised psychological care services.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41046 0
Prof Afaf Girgis
Address 41046 0
Psycho-Oncology Research Group,
Ingham Institute for Applied Medical Research,
Liverpool Hospital, Locked Bag 7103,
LIVERPOOL BC NSW 1871
Country 41046 0
Australia
Phone 41046 0
+61412142841
Fax 41046 0
+61296023221
Email 41046 0
afaf.girgis@unsw.edu.au
Contact person for public queries
Name 41047 0
Ms Hayley Candler
Address 41047 0
c/- CTNMH, University of Newcastle,
PO Box 833,
NEWCASTLE NSW 2300
Country 41047 0
Australia
Phone 41047 0
+61240335118
Fax 41047 0
+61240335692
Email 41047 0
hayley.candler@unsw.edu.au
Contact person for scientific queries
Name 41048 0
Prof Afaf Girgis
Address 41048 0
Psycho-Oncology Research Group,
Ingham Institute for Applied Medical Research,
Liverpool Hospital, Locked Bag 7103,
LIVERPOOL BC NSW 1871
Country 41048 0
Australia
Phone 41048 0
+61412142841
Fax 41048 0
+61296023221
Email 41048 0
afaf.girgis@unsw.edu.au