Trial Review

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
ACTRN12606000220561
Ethics application status
Approved
Date submitted
16/05/2006
Date registered
2/06/2006
Date last updated
10/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
To facilitate the implementation of the NHMRC “Clinical practice guidelines for the psychosocial care of adults with cancer”
Scientific title
To improve clinician's skills of assessing the supportive care needs of adult cancer patients by providing communication workshops, patient assessment tools and clinical supervision.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinicians providing care to cancer patients. 1198 0
Condition category
Condition code
Cancer 1283 1283 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This 12 month qualitative action research study uses a cyclic process to implement change in clinical practice. There are no control groups. The interventions are determined by a systematic problem-solving approach to identify barriers to change and implement actions to overcome barriers. Intervention strategies have included a 2 day communication skills workshop, the use of a Supportive Care Needs Screening Tool in routine clinical practice, the documentation of resources in a guide, and participating in supervision of clinical practice for three months.
Intervention code [1] 1048 0
Behaviour
Comparator / control treatment
There are no control groups
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1736 0
First primary outcome is participant's self report that they systematically identify psychosocial needs in clinical practice.
Timepoint [1] 1736 0
This will be self reported through a study specific survey four months post workshop.
Primary outcome [2] 1737 0
Second primary outcome is participants' skills in communication which will be identified by participants
Timepoint [2] 1737 0
Through self critique at one and four months post workshop.
Primary outcome [3] 1738 0
Third primary outcome will be frequency of use by participants of the Supportive Needs Screening Tool in practice.
Timepoint [3] 1738 0
Reported by clinicians at four months post workshop.
Primary outcome [4] 1739 0
The fourth primary outcome is the publication of an effective supportive care guideline and referral resource for the clinical setting for all participants.
Timepoint [4] 1739 0
This will be made available by the end of four months post workshop.
Secondary outcome [1] 3095 0
Secondary outcome will be participant satisfaction with the workshop measured immediately post workshop by a particpant completed questionnaire.
Timepoint [1] 3095 0
Immediately post workshop

Eligibility
Key inclusion criteria
Participants must be involved in the provision of cancer care to adult patients; participants must be involved as part of their clinical practice assessment of cancer patients; participants must be from participating agencies are the Western and Central ICS, the Loddon Mallee RICS and the Hume RICS.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants not willing to participate in the two day workshop; paticipants not nominated by their organisation.

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
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
23
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1406 0
Government body
Name [1] 1406 0
Department of Human Services Victoria
Country [1] 1406 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Peter MacCallum Cancer Centre
Address
Locked Bal 1 A'Beckett St
Melbourne 8006
Country
Australia
Secondary sponsor category [1] 1235 0
None
Name [1] 1235 0
Nil
Address [1] 1235 0
Country [1] 1235 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2765 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 2765 0
Ethics committee country [1] 2765 0
Australia
Date submitted for ethics approval [1] 2765 0
Approval date [1] 2765 0
13/09/2005
Ethics approval number [1] 2765 0
E33-05

Summary
Brief summary
It is proposed to test the refinement and dissemination of the C-CARE model of psychosocial assessment more broadly across the tumour streams at Peter Mac in the first instance and then to further refine the model in the Western and Central ICS (W&CICS) and in two Regional Integrated Cancer Services. The impetus for this project is two fold: the publication of the NHMRC Clinical Practice Guidelines for the Psychosocial Care of Adults with Cancer (NBCC & NCCI 2003) and the prioritization of psychosocial assessment within the Victorian Cancer Services Improvement Program. Funding for this project has been provided by the Department of Human Services.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35772 0
Address 35772 0
Country 35772 0
Phone 35772 0
Fax 35772 0
Email 35772 0
Contact person for public queries
Name 10237 0
Cathie Pigott
Address 10237 0
Peter MacCallum Cancer Centre
Nursing Education
Level 3
Locked Bag 1
A'Beckett Street
Melbourne VIC 8006
Country 10237 0
Australia
Phone 10237 0
+61 3 96563561
Fax 10237 0
+61 3 96561337
Email 10237 0
[email protected]
Contact person for scientific queries
Name 1165 0
Cathie Pigott
Address 1165 0
Level 3 Nursing Education
Peter MacCallum Cancer Centre
Locked Bag 1 A'Beckett Street
Melbourne VIC 8006
Country 1165 0
Australia
Phone 1165 0
+61 3 96563561
Fax 1165 0
+61 3 96561337
Email 1165 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
No additional documents have been identified.