Trial Review

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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.
Scientific title
The Role of the Cancer Care Coordinator during Breast Cancer Treatment Follow-up: A Feasibility Study.
Secondary ID [1] 283711 0
Ni known
Universal Trial Number (UTN)
Trial acronym
CCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety and depression 243678 0
Pain and mobility 243679 0
Occupational Health 243691 0
Nutritional Status 243692 0
Sexual Health 243693 0
Quality of life 243694 0
Psychological distress 243695 0
Follow-up care needs 243696 0
Condition category
Condition code
Cancer 239949 239949 0 0
Breast

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 241236 0
Treatment: Other
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.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240768 0
Changes in quality of life - measured using the SF 36
Timepoint [1] 240768 0
3 months after consultation with patient's general practitioner
Primary outcome [2] 240769 0
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
Timepoint [2] 240769 0
3 months after consultation with patient's general practitioner
Secondary outcome [1] 257441 0
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.
Timepoint [1] 257441 0
3 months after consultation with patient's general practitioner
Secondary outcome [2] 257442 0
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.
Timepoint [2] 257442 0
Approximately 1 month after the final follow-up session of the last patient.
Secondary outcome [3] 257443 0
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.
Timepoint [3] 257443 0
Approximately 1 month after the final follow-up session of the last patient.

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.
Minimum age
45 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/10/2009
Actual
31/10/2009
Date of last participant enrolment
Anticipated
30/07/2010
Actual
30/07/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 243618 0
Government body
Name [1] 243618 0
Western Australia Cancer and Palliative Care Network
Country [1] 243618 0
Australia
Primary sponsor type
Individual
Name
Prof Moyez Jiwa
Address
Curtin Health Innovation Research Institute
Curtin University of Technology
GPO Box U1987
Perth, WA 6845
Country
Australia
Secondary sponsor category [1] 237067 0
Individual
Name [1] 237067 0
Christobel Saunders
Address [1] 237067 0
Sir Charles Gaidner Hospital Breast Centre
Sir Charles Gaidner Hospital
1st Floor, G-Block
Hospital Avenue,
Nedlands, WA 6009
Country [1] 237067 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243744 0
Curtin Human Research Ethics Committee
Ethics committee address [1] 243744 0
Ethics committee country [1] 243744 0
Australia
Date submitted for ethics approval [1] 243744 0
25/08/2009
Approval date [1] 243744 0
25/09/2009
Ethics approval number [1] 243744 0
HR 158/2009

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

Contacts
Principal investigator
Name 30154 0
Prof Moyez Jiwa
Address 30154 0
Curtin University,
GPO Box U1987
Bentley, Perth, Western Australia 6845
Country 30154 0
Australia
Phone 30154 0
+ 61 8 9266 1768
Fax 30154 0
Email 30154 0
m.jiwa@curtin.edu.au
Contact person for public queries
Name 13401 0
Moyez Jiwa
Address 13401 0
Curtin Health Innovation Research Institute
Curtin University of Technology
GPO Box U1985
Perth, WA 6845
Country 13401 0
Australia
Phone 13401 0
+61 8 9266 9212
Fax 13401 0
+61 8 9266 9801
Email 13401 0
w.chanshepingdelfos@curtin.edu.au
Contact person for scientific queries
Name 4329 0
Prof Moyez Jiwa
Address 4329 0
Curtin Health Innovation Research Institute
Curtin University of Technology
GPO Box U1985
Perth, WA 6845
Country 4329 0
Australia
Phone 4329 0
+61 8 9266 1768
Fax 4329 0
+61 8 9266 9801
Email 4329 0
m.jiwa@curtin.edu.au

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
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