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Trial registered on ANZCTR
Registration number
ACTRN12609000894291
Ethics application status
Approved
Date submitted
25/09/2009
Date registered
13/10/2009
Date last updated
6/12/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
The Cancer Care Coordination Project: The Role a Cancer Care Coordinator during Breast Cancer Treatment Follow-up.
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Scientific title
The Role of the Cancer Care Coordinator during Breast Cancer Treatment Follow-up: A Feasibility Study.
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Secondary ID [1]
283711
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Ni known
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Universal Trial Number (UTN)
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Trial acronym
CCC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anxiety and depression
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Pain and mobility
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Occupational Health
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Nutritional Status
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Sexual Health
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Quality of life
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Psychological distress
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Follow-up care needs
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Condition category
Condition code
Cancer
239949
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0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
No defined treatment. The needs of 30 breast cancer follow-up patients will be assessed at the beginning of the study by a team of medical and allied health professionals (MDT, multidisciplinary team). The cancer care coordinator will forward the patient-management recommendations of the team to the patients' general practitioner (GP). The GP will subsequently consult the patient and decide whether to adopt the recommendations received: referring the patient to the nominated allied health professionals within the community. To facilitate communication amongst health professionals, the patient's GP and the nominated allied health professionals will have free access to a web-based information sharing platform. The treatments provided will depend on the needs of the patients as assessed at the beginning of the study.
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Intervention code [1]
241236
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Treatment: Other
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Comparator / control treatment
This feasibility study will explore the impact of the Cancer Care Coordinator/MDT on the quality of life, anxiety and depression, and psychological distress of 30 breast cancer follow-up patients. The study also aims to observe the uptake of the recommendations of the MDT model and its acceptability to patients, general practitioners and allied health professionals. The SF 36, Hospital Anxiety & Depression Scale questionnaire (HADS), distress thermometer and the care assessment needs questionnaire will be used at the beginning of the study to assess the needs of the participants. The SF36, HADS, distress thermometer and the patient global improvement (PGI) questionnaire will again be used at the end of the study (three months after the participant had seen their GP) to determine if the assessed needs have been fulfilled.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Changes in quality of life - measured using the SF 36
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Assessment method [1]
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Timepoint [1]
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3 months after consultation with patient's general practitioner
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Primary outcome [2]
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Mean of assessed needs being examined and followed up by allied health professionals - measured using the Hospital Anxiety and Depression Scale (HADS) questionnaire, the distress thermometer, the care assessment needs questionnaire and the patient global improvement (PGI) questionnaire
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Assessment method [2]
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Timepoint [2]
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3 months after consultation with patient's general practitioner
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Secondary outcome [1]
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To observe the uptake of recommendations of the multidisciplinary team model. The number of endorsed recommendations will be noted against the total number of recommendations from the multidisciplinary team.
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Assessment method [1]
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Timepoint [1]
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3 months after consultation with patient's general practitioner
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Secondary outcome [2]
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Acceptability of the multidisciplinary team model to patients, general practitioners and allied health professionals. All mentioned parties will be requested to complete a feedback questionnaire at the end of the trial. Patients and health professionals will be invited to two separate audio-recorded feedback sessions to explore the value of the model.
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Assessment method [2]
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Timepoint [2]
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Approximately 1 month after the final follow-up session of the last patient.
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Secondary outcome [3]
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To explore the use of the web-based information sharing platform. During the audio-recorded feedback sessions, the health professionals will be asked to provide feedback on the extent to which the platform has enabled communication and facilitated patient management.
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Assessment method [3]
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Timepoint [3]
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Approximately 1 month after the final follow-up session of the last patient.
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Eligibility
Key inclusion criteria
The inclusion criteria are as follow:
Have been diagnosed with breast cancer, age between 45 - 65 years old, have completed adjuvant treatment, are disease free, and are between 12 - 24 months post-diagnosis.
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Minimum age
45
Years
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Maximum age
65
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
The exclusion criteria are:
Less than 45 or over 65 years old of age, undergoing active treatment, and are not disease free
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A breast care nurse of Sir Charles Gaidner Hospital has been chosen to act as a cancer care coordinator for the purpose of this study. As part of scheduling follow-up appointments (as per the hospital's protocol), the nurse will inform those who satisfy the inclusion criteria about the study. The patients will only then be mailed the information sheet if they express an interest in reading more about the study. The prospective participants will also be requested to make an appointment with the designated breast care nurse if they consent to participating in the study. Those who do not satisfy the inclusion criteria or who express no interest in the study will have their usual appointment with a breast care nurse of Sir Charles Gaidner Hospital.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
31/10/2009
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Actual
31/10/2009
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Date of last participant enrolment
Anticipated
30/07/2010
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Actual
30/07/2010
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Western Australia Cancer and Palliative Care Network
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Address [1]
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Sir Charles Gaidner Hospital
2nd Floor, R Block
Hospital Avenue,
Nedlands, WA 6009
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Prof Moyez Jiwa
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Address
Curtin Health Innovation Research Institute
Curtin University of Technology
GPO Box U1987
Perth, WA 6845
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Christobel Saunders
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Address [1]
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Sir Charles Gaidner Hospital Breast Centre
Sir Charles Gaidner Hospital
1st Floor, G-Block
Hospital Avenue,
Nedlands, WA 6009
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Curtin Human Research Ethics Committee
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Ethics committee address [1]
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Curtin University
GPO Box U 1987
Bentley, Perth, Western Australia 6845
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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25/08/2009
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Approval date [1]
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25/09/2009
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Ethics approval number [1]
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HR 158/2009
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Summary
Brief summary
Early detection of cancer and advances in cancer treatment has allowed most people with cancer to survive at least 5 years from diagnosis. The wide range of needs associated with cancer survivorship is often overlooked. Follow-up care has been adopted to aid the detection of recurrence, promote behavioural changes and facilitate psychosocial adjustments.
Follow-up care when performed by cancer specialists is not cost-effective and puts undue load on the cancer clinics. Most recurrences occur between appointments with a specialist and are detected by general practitioners (GPs). Currently, services offered by allied health professionals (AHP) are uncoordinated; patients thus face the likelihood of duplication of treatments, increased financial burden or incomplete care.
We propose a feasibility study for cancer follow-up within a primary care setting based on the multi-disciplinary team (MDT) model.
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Trial website
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Trial related presentations / publications
Peer reviewed publication here:http://www.collegianjournal.com/article/S1322-7696%2812%2900035-2/abstract
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Public notes
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Contacts
Principal investigator
Name
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Prof Moyez Jiwa
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Address
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Curtin University,
GPO Box U1987
Bentley, Perth, Western Australia 6845
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Country
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Australia
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Phone
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+ 61 8 9266 1768
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Moyez Jiwa
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Address
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Curtin Health Innovation Research Institute
Curtin University of Technology
GPO Box U1985
Perth, WA 6845
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Country
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Australia
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Phone
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+61 8 9266 9212
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Fax
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+61 8 9266 9801
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Prof Moyez Jiwa
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Address
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Curtin Health Innovation Research Institute
Curtin University of Technology
GPO Box U1985
Perth, WA 6845
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Country
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Australia
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Phone
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+61 8 9266 1768
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Fax
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+61 8 9266 9801
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Email
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[email protected]
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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.
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