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Trial registered on ANZCTR
Registration number
ACTRN12620001083987
Ethics application status
Approved
Date submitted
23/06/2020
Date registered
20/10/2020
Date last updated
20/10/2020
Date data sharing statement initially provided
20/10/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluating a shared model of cancer follow-up care between general practitioners and radiation oncologists, for patients with breast, prostate or colorectal cancer.
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Scientific title
Evaluating the acceptability, feasibility and efficacy of a shared model of cancer follow-up care utilising digital health tools and the transfer of clinical information between general practitioners and radiation oncologists, for patients with breast, prostate or colorectal cancer.
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Secondary ID [1]
301602
0
nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
317982
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Prostate cancer
319426
0
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Colorectal cancer
319427
0
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Condition category
Condition code
Cancer
316016
316016
0
0
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Breast
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Cancer
316017
316017
0
0
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Prostate
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Cancer
316018
316018
0
0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
1. Intervention name
Shared model of cancer follow-up care between general practitioners and radiation oncologists, for patients with breast, prostate or colorectal cancer.
2. Why
The rising incidence of cancer and increasing number of cancer survivors has resulted in the need to find alternative models of care for cancer follow-up care. The acceptability for follow-up care in general practice is growing, and acceptance increases with shared-care models where oncologists are still overseeing care. However, a major barrier to this model is the effective two-way exchange of information in real-time between oncologists and general practitioners. Improved communication technology plays an important role in the acceptability and feasibility of cancer shared follow-up care.
3. What
The intervention is additional radiation oncology follow-up appointments for the patient with their general practitioner; whilst the radiation oncologist is informed in real-time via the hospital oncology information system (electronic record).
Digital health technology (PROsaiq) will be used to transfer the review information from the general practitioner directly into the hospital system. The radiation oncologist will oversee the care by accessing the review information directly, and identify if the patient needs any further medical intervention or support.
4. Who provided
The general practitioner will complete a two hour radiation oncology course online (eviQ). A 30-minute training session will be provided by a radiation oncologist directly to the general practitioner on how to access the clinical assessment link, and what to do during the follow-up review by a radiation oncologist (review sleep, weight, skin reactions, bladder/bowel, prostate blood level).
The training to general practitioners will include how to review radiation oncology specific information:
Breast: Fatigue, ECOG (a scale of performance by Eastern Cooperative Oncology Group), appetite, weight loss, chest/breast pain, telangiectasia, lymphodema-related fibrosis, disease state – local/regional/distant
Colorectal: Fatigue, ECOG, appetite, weight loss, proctitis, pelvic pain, vomiting, diarrhoea, disease state – local/regional/distant
Prostate: Fatigue, ECOG, erectile function, dysuria, rectal haemorrhage, disease state – local/regional/distant
5. How
The intervention will be delivered at the patient’s general practitioner’s clinic. The review data will be sent in real-time to the hospital.
6. Where
Within the Illawarra Shoalhaven local health district region.
7. When and how much
The intervention, will involve the patient visiting their general practitioner for 2x 20 minute appointments, six months apart. The total duration of study participation is 8 months.
8. Researchers will monitor patient participation by monitoring the data sent into the hospitals oncology information system.
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Intervention code [1]
317909
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Treatment: Other
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Comparator / control treatment
no control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
324222
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Assessment of patient-perceived acceptability and feasibility of the intervention using semi-structured interviews.
One on one phone and audio-recorded.
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Assessment method [1]
324222
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Timepoint [1]
324222
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Baseline before intervention; and 6-months post-enrolment (immediately after the second intervention appointment).
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Primary outcome [2]
324739
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Assessment of general practitioner-perceived acceptability and feasibility of the intervention using semi-structured interviews.
One on one phone and audio-recorded.
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Assessment method [2]
324739
0
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Timepoint [2]
324739
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Baseline before intervention; and 6-months post-enrolment (immediately after the second intervention appointment).
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Primary outcome [3]
324740
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Assessment of radiation oncologist-perceived acceptability and feasibility of the intervention using semi-structured interviews.
One on one phone and audio-recorded.
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Assessment method [3]
324740
0
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Timepoint [3]
324740
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Baseline before intervention; and 6-months post-enrolment (immediately after the second intervention appointment).
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Secondary outcome [1]
384110
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Level of agreement analysis between general practitioners and radiation oncologists for fatigue. Using CTC 5-point scale.
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Assessment method [1]
384110
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Timepoint [1]
384110
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At the first follow-up review appointment.
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Secondary outcome [2]
387111
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Level of agreement analysis between general practitioners and radiation oncologists for ECOG Performance Status using the ECOG 5-point scale.
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Assessment method [2]
387111
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Timepoint [2]
387111
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At the first follow-up review appointment.
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Secondary outcome [3]
387112
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Level of agreement analysis between general practitioners and radiation oncologists for appetite. Using a VAS 5-point scale.
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Assessment method [3]
387112
0
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Timepoint [3]
387112
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At the first follow-up review appointment.
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Secondary outcome [4]
387113
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Level of agreement analysis between general practitioners and radiation oncologists for weight loss. Using the CTCAE 5-point scale.
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Assessment method [4]
387113
0
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Timepoint [4]
387113
0
At the first follow-up review appointment.
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Secondary outcome [5]
387114
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Level of agreement analysis between general practitioners and radiation oncologists for pain. Using the CTCAE 5-point scale.
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Assessment method [5]
387114
0
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Timepoint [5]
387114
0
At the first follow-up review appointment.
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Secondary outcome [6]
387115
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Level of agreement analysis between general practitioners and radiation oncologists telangiectasia. Using the CTC SkinLate RT Morbidity Scoring 5-point scale.
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Assessment method [6]
387115
0
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Timepoint [6]
387115
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At the first follow-up review appointment.
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Secondary outcome [7]
387116
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Level of agreement analysis between general practitioners and radiation oncologists proctitis. Using the CTCAE v5 5-point scale.
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Assessment method [7]
387116
0
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Timepoint [7]
387116
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At the first follow-up review appointment.
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Secondary outcome [8]
387117
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Level of agreement analysis between general practitioners and radiation oncologists vomiting. Using the CTC 5-point scale.
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Assessment method [8]
387117
0
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Timepoint [8]
387117
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At the first follow-up review appointment.
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Secondary outcome [9]
387118
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Level of agreement analysis between general practitioners and radiation oncologists diarrhoea. Using the CTC 5-point scale.
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Assessment method [9]
387118
0
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Timepoint [9]
387118
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At the first follow-up review appointment.
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Secondary outcome [10]
387119
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Level of agreement analysis between general practitioners and radiation oncologists erectile function. Using the CTC 4-point scale.
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Assessment method [10]
387119
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Timepoint [10]
387119
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At the first follow-up review appointment.
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Secondary outcome [11]
387120
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Level of agreement analysis between general practitioners and radiation oncologists dysuria. Using the CTC 4-point scale.
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Assessment method [11]
387120
0
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Timepoint [11]
387120
0
At the first follow-up review appointment.
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Secondary outcome [12]
387121
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Level of agreement analysis between general practitioners and radiation oncologists for rectal haemorrhage. Using the CTCAE 5-point scale.
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Assessment method [12]
387121
0
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Timepoint [12]
387121
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At the first follow-up review appointment.
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Secondary outcome [13]
387122
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Level of agreement analysis between general practitioners and radiation oncologists disease state: local, regional, distant for breast. This will be assessed with a physcial examaniation of the breast, lymph glands and palpate the liver.
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Assessment method [13]
387122
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Timepoint [13]
387122
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At the first follow-up review appointment.
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Eligibility
Key inclusion criteria
Radiation oncologist:
1) have treated patients for breast, prostate or colorectal cancer
Patient:
1) have a previous diagnosis of colorectal, breast or prostate cancer,
2) have completed curative intent radiotherapy treatment at least two and half years ago,
3) be over 18 years of age,
4) can understand and speak English,
5) have a general practitioner willing to participate.
General practitioner:
1)Referring general practitioner of breast, colorectal or prostate cancer patient who has consented to taking place in the study.
b) Has internet access.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria are patients that have suspected or confirmed recurrence.
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Study design
Purpose of the study
Educational / counselling / training
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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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
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Statistical methods / analysis
Thematic analysis will be used to analyse the qualitative data. The data will be mapped and emergent themes identified. The themes will be compared across the two sites (Wollongong and Shoalhaven) and triangulated (between radiation oncologists, patients and general practitioners).
The clinical assessment data will be extracted from the oncology information system, and Cohen’s Kappa will determine the level of agreement for each item between general practitioners and radiation oncologists. The agreement will assess the concordance between two measurements of each variable with the expectation that there will be near-perfect agreement on each item (>0.81). The results of the analysis and level of agreement will be presented to the general practitioners and radiation oncologists to guide any additional education and training.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2021
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Actual
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Date of last participant enrolment
Anticipated
28/02/2021
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Actual
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Date of last data collection
Anticipated
30/09/2021
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
16965
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Wollongong Hospital - Wollongong
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Recruitment hospital [2]
16966
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Shoalhaven Hospital - Nowra
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Recruitment postcode(s) [1]
30625
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2500 - Wollongong
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Recruitment postcode(s) [2]
30626
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2541 - Nowra
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Funding & Sponsors
Funding source category [1]
306034
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Hospital
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Name [1]
306034
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Radiation Oncology - Illawarra Shoalhaven Local Health District
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Address [1]
306034
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Wollongong Hospital
Crown Street
Wollongong NSW 2500
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Country [1]
306034
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Australia
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Primary sponsor type
University
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Name
University of Wollongong
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Address
Northfield Avenue, University of Wollongong, Wollongong, NSW 2500
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Country
Australia
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Secondary sponsor category [1]
306496
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None
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Name [1]
306496
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Address [1]
306496
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Country [1]
306496
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306264
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The University of Wollongong and the Illawarra Shoalhaven Local Health District Health and Medical HREC
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Ethics committee address [1]
306264
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Human Research Ethics Committee
University of Wollongong
Northfields Avenue, Wollongong
NSW. 2500
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Ethics committee country [1]
306264
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Australia
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Date submitted for ethics approval [1]
306264
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09/02/2020
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Approval date [1]
306264
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12/05/2020
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Ethics approval number [1]
306264
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2020/ETH00301
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Summary
Brief summary
The purpose of this study is to test the feasibility and acceptability of a shared-care model involving specialists and GPs for post-radiotherapy treatment cancer follow-up.
Who is it for?
You may be eligible for this study if you are aged 18 or older, and have completed radiotherapy treatment for breast, prostate or colorectal cancer at least two and a half years ago.
Study details
Participants in this study will attend a series of post-treatment follow-up appointments with their regular GP who will assess their health and reviews for signs of cancer recurrence. The GP will complete a follow-up review with the patient using a system that is directly linked to the hospital so the radiation oncologist can oversee the results and assess if further medical intervention or support is required.
The patient maintains their standard care with their radiation oncologist, with one appointment of 15 minutes. Over the six months, the patient is being offered an additional two review appointments with their general practitioner, 20 to 30 minutes each.
As part of the study all participants will be asked to attend two interviews, before and after the study period to discuss how they felt about the shared-care model of cancer follow-up care.
It is hoped this research will demonstrate the feasibility and usefulness of the new model of care which could influence future post-treatment cancer care.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
103286
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Mrs Tiffany Sandell
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Address
103286
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Research Central, Level 8
Wollongong Hospital
Crown Street Wollongong
NSW 2500
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Country
103286
0
Australia
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Phone
103286
0
+61 479136404
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Fax
103286
0
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Email
103286
0
[email protected]
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Contact person for public queries
Name
103287
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Mrs Tiffany Sandell
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Address
103287
0
Research Central, Level 8
Wollongong Hospital
Crown Street Wollongong
NSW 2500
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Country
103287
0
Australia
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Phone
103287
0
+61 492803828
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Fax
103287
0
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Email
103287
0
[email protected]
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Contact person for scientific queries
Name
103288
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Mrs Tiffany Sandell
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Address
103288
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Research Central, Level 8
Wollongong Hospital
Crown Street Wollongong
NSW 2500
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Country
103288
0
Australia
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Phone
103288
0
+61 492803828
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Fax
103288
0
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Email
103288
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
8306
Study protocol
380057-(Uploaded-21-09-2020-13-54-15)-Study-related document.docx
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.
Download to PDF