Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001715167
Ethics application status
Approved
Date submitted
17/09/2019
Date registered
5/12/2019
Date last updated
5/12/2019
Date data sharing statement initially provided
5/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving patient and GP information and communication with an electronic care plan
Scientific title
Improving patient and GP information and communication with an electronic care plan for individuals with colorectal cancer
Secondary ID [1] 299163 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 314237 0
Condition category
Condition code
Cancer 312602 312602 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients at Footscray Hospital will receive a personalised care plan summary which has the following components including Cancer stage, Planned treatment, Planned follow-up visits and Cancer helpline resources. The care plan summary will be generated and provided to the patient during their second consultation with the oncology clinician.
The consultation with the clinician will usually take approximately 30 minutes where they are provided the care plan and informed that they will be asked to complete a survey about how useful the care plan is in 6 months. The patient will be approached to complete the survey at a further consultation with the clinician.

The care plan summary will be generated from a HREC approved colorectal registry which all colorectal cancer patients at Footscray Hospital are entered into.

This study utilised a waiver of consent approach where the participants will be told about the study and a questionnaire which will be provided to them for completion after they have completed their first course of the treatment. No written consent will be obtained from the participants.

The duration of the study is approximately 7 months.

The plan is to roll this out to other centres and for other tumour streams if determined to be an effective communication tool.
Intervention code [1] 315449 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321255 0
The successful development of electronically generated care plan for Colorectal Cancer (CRC) patients. This outcome will be assessed by running a report from the database on how many patients receive the care plan from the oncologist. We can measure this by comparing with the total number of patients entered onto the database.
Timepoint [1] 321255 0
Patients will receive their personalised care plan at their second clinic visit
Primary outcome [2] 321256 0
Patient feedback and level of satisfaction with the information provided on their care plan and at their initial oncology clinic visits. This will be assessed through a patient survey that patients will be asked to complete.
The name of the survey developed for this study is "Bowel Cancer Patient Information Survey'
Timepoint [2] 321256 0
At completion of patient's treatment
Primary outcome [3] 321406 0
To evaluate and analyse General Practitioner (GP) satisfaction of the care plan through an evaluation survey. The care plan will be uploaded to the hospital system and sent out electronically to GPs,
The name of the survey developed for this study is 'GP Care Plan Evaluation Survey'
Timepoint [3] 321406 0
The evaluation of GPs will take place as soon as possible after the GP has received the care plan.
Secondary outcome [1] 374466 0
Level of recommendations of the introduction of the personalised care plan to other tumour streams and hospitals. This will be based on the evaluation survey for patients (Bowel Cancer Patient Information Survey).
Timepoint [1] 374466 0
Evaluation and analysis of the Bowel Cancer Patient Information Survey will take place in the second quarter of 2020 and recommendations included in final report.
Secondary outcome [2] 377552 0
Level of recommendations of the introduction of the personalised care plan to other tumour streams and hospitals. This will be based on the evaluation survey for GPs (GP Care Plan Evaluation Survey).
Timepoint [2] 377552 0
Evaluation and analysis of the GP Care Plan Evaluation Survey will take place in the second quarter of 2020 and recommendations included in final report.

Eligibility
Key inclusion criteria
• Patients with Stage II or III colon cancer
• Patients referred to oncology following surgery
• Patients fit for adjuvant chemotherapy and/or routine surveillance
• GPs who are seeing participants on the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Colorectal patients with Stage I or IV disease
• Primary rectal cancer patients

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
As this is a feasibility study, no formal statistical calculations have been performed. Data generated from this study will be reported using descriptive statistics, e.g. proportions and medians.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/12/2019
Actual
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14803 0
Western Hospital - Footscray - Footscray
Recruitment postcode(s) [1] 28052 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 303704 0
Government body
Name [1] 303704 0
Western & Central Melbourne Integrated Cancer Service
Country [1] 303704 0
Australia
Primary sponsor type
Other
Name
The Walter & Eliza Hall Institute of Medical Research
Address
1G Royal Parade, Parkville, Victoria 3052
Country
Australia
Secondary sponsor category [1] 303813 0
None
Name [1] 303813 0
Address [1] 303813 0
Country [1] 303813 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304229 0
Melbourne Health HREC
Ethics committee address [1] 304229 0
Royal Melbourne Hospital
300 Grattan Street (corner of Royal Parade)
Parkville, Victoria 3050
Australia
Ethics committee country [1] 304229 0
Australia
Date submitted for ethics approval [1] 304229 0
29/05/2019
Approval date [1] 304229 0
25/07/2019
Ethics approval number [1] 304229 0
HREC/54744/MH-2019

Summary
Brief summary
The purpose of this study is to collect clinical data on Colorectal cancer patients with Stage II and Stage III disease and process this on the colorectal cancer data registry in order to generate a personalised care plan summary.

Who is it for?
You may be eligible for this study if you are a patient with Stage II or III colon cancer and fit for chemotherapy. You may also be eligible for this study if you are a GP monitoring patients with colorectal cancer fitting the inclusion criteria.

Study details
A personalised care plan summary will be provided during the second consultation visit with the oncologist and has the following components including cancer stage, planned treatment, planned follow-up visits and cancer helpline resources. This care plan summary will be created by your oncologist and will take an additional 10 minutes to generate the care plan from the database and then go through the information with you. You will be requested to complete a questionnaire after completion of your treatment.

It is hoped that results generated from this study will help us determine if the provision of a personalised care plan can be extended to other tumour streams to help other patients.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96210 0
Prof Peter Gibbs
Address 96210 0
Walter & Eliza Hall Institute of Medical Research
1G Royal Pde
Parkville
VIC 3052
Country 96210 0
Australia
Phone 96210 0
+61 3 9345 2897
Fax 96210 0
Email 96210 0
[email protected]
Contact person for public queries
Name 96211 0
Michael Harold
Address 96211 0
Walter & Eliza Hall Institute of Medical Research
1G Royal Pde
Parkville
VIC 3052
Country 96211 0
Australia
Phone 96211 0
+61 3 9345 2799
Fax 96211 0
Email 96211 0
[email protected]
Contact person for scientific queries
Name 96212 0
Peter Gibbs
Address 96212 0
Walter & Eliza Hall Institute of Medical Research
1G Royal Pde
Parkville
VIC 3052
Country 96212 0
Australia
Phone 96212 0
+61 3 9345 2897
Fax 96212 0
Email 96212 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?

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.