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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.
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.
Secondary ID [1] 301602 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 317982 0
Prostate cancer 319426 0
Colorectal cancer 319427 0
Condition category
Condition code
Cancer 316016 316016 0 0
Breast
Cancer 316017 316017 0 0
Prostate
Cancer 316018 316018 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 317909 0
Treatment: Other
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324222 0
Assessment of patient-perceived acceptability and feasibility of the intervention using semi-structured interviews.

One on one phone and audio-recorded.
Timepoint [1] 324222 0
Baseline before intervention; and 6-months post-enrolment (immediately after the second intervention appointment).
Primary outcome [2] 324739 0
Assessment of general practitioner-perceived acceptability and feasibility of the intervention using semi-structured interviews.

One on one phone and audio-recorded.
Timepoint [2] 324739 0
Baseline before intervention; and 6-months post-enrolment (immediately after the second intervention appointment).
Primary outcome [3] 324740 0
Assessment of radiation oncologist-perceived acceptability and feasibility of the intervention using semi-structured interviews.

One on one phone and audio-recorded.
Timepoint [3] 324740 0
Baseline before intervention; and 6-months post-enrolment (immediately after the second intervention appointment).
Secondary outcome [1] 384110 0
Level of agreement analysis between general practitioners and radiation oncologists for fatigue. Using CTC 5-point scale.
Timepoint [1] 384110 0
At the first follow-up review appointment.
Secondary outcome [2] 387111 0
Level of agreement analysis between general practitioners and radiation oncologists for ECOG Performance Status using the ECOG 5-point scale.
Timepoint [2] 387111 0
At the first follow-up review appointment.
Secondary outcome [3] 387112 0
Level of agreement analysis between general practitioners and radiation oncologists for appetite. Using a VAS 5-point scale.
Timepoint [3] 387112 0
At the first follow-up review appointment.
Secondary outcome [4] 387113 0
Level of agreement analysis between general practitioners and radiation oncologists for weight loss. Using the CTCAE 5-point scale.
Timepoint [4] 387113 0
At the first follow-up review appointment.
Secondary outcome [5] 387114 0
Level of agreement analysis between general practitioners and radiation oncologists for pain. Using the CTCAE 5-point scale.
Timepoint [5] 387114 0
At the first follow-up review appointment.
Secondary outcome [6] 387115 0
Level of agreement analysis between general practitioners and radiation oncologists telangiectasia. Using the CTC SkinLate RT Morbidity Scoring 5-point scale.
Timepoint [6] 387115 0
At the first follow-up review appointment.
Secondary outcome [7] 387116 0
Level of agreement analysis between general practitioners and radiation oncologists proctitis. Using the CTCAE v5 5-point scale.
Timepoint [7] 387116 0
At the first follow-up review appointment.
Secondary outcome [8] 387117 0
Level of agreement analysis between general practitioners and radiation oncologists vomiting. Using the CTC 5-point scale.
Timepoint [8] 387117 0
At the first follow-up review appointment.
Secondary outcome [9] 387118 0
Level of agreement analysis between general practitioners and radiation oncologists diarrhoea. Using the CTC 5-point scale.
Timepoint [9] 387118 0
At the first follow-up review appointment.
Secondary outcome [10] 387119 0
Level of agreement analysis between general practitioners and radiation oncologists erectile function. Using the CTC 4-point scale.
Timepoint [10] 387119 0
At the first follow-up review appointment.
Secondary outcome [11] 387120 0
Level of agreement analysis between general practitioners and radiation oncologists dysuria. Using the CTC 4-point scale.
Timepoint [11] 387120 0
At the first follow-up review appointment.
Secondary outcome [12] 387121 0
Level of agreement analysis between general practitioners and radiation oncologists for rectal haemorrhage. Using the CTCAE 5-point scale.
Timepoint [12] 387121 0
At the first follow-up review appointment.
Secondary outcome [13] 387122 0
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.
Timepoint [13] 387122 0
At the first follow-up review appointment.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are patients that have suspected or confirmed recurrence.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
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.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2021
Actual
Date of last participant enrolment
Anticipated
28/02/2021
Actual
Date of last data collection
Anticipated
30/09/2021
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16965 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 16966 0
Shoalhaven Hospital - Nowra
Recruitment postcode(s) [1] 30625 0
2500 - Wollongong
Recruitment postcode(s) [2] 30626 0
2541 - Nowra

Funding & Sponsors
Funding source category [1] 306034 0
Hospital
Name [1] 306034 0
Radiation Oncology - Illawarra Shoalhaven Local Health District
Country [1] 306034 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfield Avenue, University of Wollongong, Wollongong, NSW 2500
Country
Australia
Secondary sponsor category [1] 306496 0
None
Name [1] 306496 0
Address [1] 306496 0
Country [1] 306496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306264 0
The University of Wollongong and the Illawarra Shoalhaven Local Health District Health and Medical HREC
Ethics committee address [1] 306264 0
Ethics committee country [1] 306264 0
Australia
Date submitted for ethics approval [1] 306264 0
09/02/2020
Approval date [1] 306264 0
12/05/2020
Ethics approval number [1] 306264 0
2020/ETH00301

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

Contacts
Principal investigator
Name 103286 0
Mrs Tiffany Sandell
Address 103286 0
Research Central, Level 8
Wollongong Hospital
Crown Street Wollongong
NSW 2500
Country 103286 0
Australia
Phone 103286 0
+61 479136404
Fax 103286 0
Email 103286 0
[email protected]
Contact person for public queries
Name 103287 0
Tiffany Sandell
Address 103287 0
Research Central, Level 8
Wollongong Hospital
Crown Street Wollongong
NSW 2500
Country 103287 0
Australia
Phone 103287 0
+61 492803828
Fax 103287 0
Email 103287 0
[email protected]
Contact person for scientific queries
Name 103288 0
Tiffany Sandell
Address 103288 0
Research Central, Level 8
Wollongong Hospital
Crown Street Wollongong
NSW 2500
Country 103288 0
Australia
Phone 103288 0
+61 492803828
Fax 103288 0
Email 103288 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8306Study 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.