Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000068662
Ethics application status
Approved
Date submitted
26/10/2022
Date registered
20/01/2023
Date last updated
20/01/2023
Date data sharing statement initially provided
20/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the impact of a novel, shared model of care on the quality of long term cancer follow-up
Scientific title
Evaluating the impact of a novel, shared model of care on the quality of long term cancer follow-up for breast and colorectal cancer patients
Secondary ID [1] 308273 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 328051 0
colorectal cancer 328052 0
Condition category
Condition code
Cancer 325108 325108 0 0
Bowel - Anal
Cancer 325109 325109 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 325110 325110 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 325111 325111 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a novel, shared model of care between cancer services and primary health care using an interactive e-care plan called Inca and telehealth using telemedicine technology. It is being implemented at 2 public and 2 private cancer services in the South Eastern Sydney Local Health District.
The e-care plan program is integrated with GP clinical information systems and includes care plan templates for colorectal and breast cancer follow-up care developed from the published literature and agreed guidelines for survivorship care plans. The e-care plan program provides a collaborative space for clinicians and patients to agree on the goals, tasks, responsibilities and the scheduling and monitoring of care. Other functionalities include the sharing of pathology results, measures (e.g. BMI, blood pressure), a health summary and a progress notes section for the specialist, GP or patient to add a note. Documents can be uploaded and downloaded. It provides the basis for non-urgent communication between specialists, GPs, patients and other care team members (e.g. allied health providers) who can be added to the care team and given access.
Inca automatically emails notifications to the care team when changes are made to the e-care plan or when upcoming tasks and appointments are due. Patients will be emailed reminders for appointments or tasks that are upcoming from Inca.
The e-care plan is not integrated with cancer service clinical systems. Cancer services and patients access the e-care plan through an online portal.
This is a non-randomised quasi-experimental trial. Patients at the St George Cancer Centre and the Prince of Wales Private will be allocated to the intervention. Patients at the Prince of Wales Nelune Comprehensive Cancer Centre and the St George Private Hospital will be allocated to the comparison group that will receive a delayed intervention after 12 months.
Brief training to access and use the e-care plan will be provided at baseline by a researcher to specialists, care coordinators and GPs in the intervention group. This will be face to face and take around 15 mins for GPs and 30 mins for specialists and care coordinators. Precedence Healthcare, the e-care plan software provider, will email patients information on how to access and use the e-care plan. Access to user manuals, videos and technical support will also be available to all participants on the Precedence Healthcare website.
The intervention process:
1. Patient and GP enrolment
2. E-care plan connector installed remotely at general practices within two weeks of enrolment
3. Brief face to face training (15 mins) provided to the GP by the researcher at the time the software is installed or soon after
4. GP initiates e-care plan and gives e-care plan access to the specialist and care coordinator (at the time of training or first patient visit)
5. Brief face to face training (30 mins) provided to the specialist and care coordinator at the time of tailoring the care plan for the patient. Other care team members can be added (e.g. surgeon, radiation oncologist)
6. Patient visits GP, care plan agreed and shared care begins. Each task completed at an appointment is checked as completed within the e-care plan to assist with monitoring care
7. Patient receives an email with information on how to access and use the e-care plan as soon as the e-care plan is agreed
8. Care coordinator monitors the e-care plan routinely every one to two weeks to check that patients have attended appointments and tasks have been completed. The care coordinator follows-up with the clinician or patient as needed. (There is no mandatory requirement for the GP or specialist to check the care plan regularly).
9. Schedule of patient visits to GP and specialist continues as planned. The care plan can be reviewed and edited by the GP and specialist with the patient based on their needs, such as tailoring lifestyle goals, adding patient activities (e.g. make time each day to do something relaxing or enjoyable, join an exercise program) and changing the schedule of appointments between the specialist and GP. Other care team members or carers can also be added.
10. Web conference/phone calls and telemedicine available to support timely access to cancer centre when needed by the specialist, GP or patient
Intervention code [1] 325003 0
Treatment: Other
Comparator / control treatment
This is a quasi-experimental study. Patients at two of the cancer services will be recruited to the comparison group. They will be provided with usual cancer follow-up care which is provided face to face by the specialist only. After 9-12 months in follow-up care, these patients will move to shared follow-up care with their GP.
Control group
Active

Outcomes
Primary outcome [1] 332931 0
Access to and continuity of follow-up care will be assessed by comparing participant satisfaction and experiences with follow-up care within and between groups.
Methods:
Questionnaires will be administered at baseline, 9 months plus 18 months post commencement of follow-up care for delayed intervention group:
Short Form Patient Satisfaction Questionnaire (Marshall GN, 1994) and The Survivors Unmet Needs Survey (access and continuity of care subscale) (Campbell HS, 2011)
Qualitative interviews with a sample of intervention participants (10 patients, 5-7 GPs and 3-5 specialists) by phone with a researcher at 9 months and 18 months post commencement of follow-up care for the delayed intervention group
Timepoint [1] 332931 0
9 months post commencement of follow-up care plus 18 months for the delayed intervention group
Primary outcome [2] 333121 0
The quality of communication and information shared to support patient follow-up will be assessed by comparing participant satisfaction and experiences with communication and information sharing within and between groups.
Methods
Questionnaires will be administered at baseline, 9 months plus 18 months post commencement of follow-up care for delayed intervention group:
The Short Form Patient Satisfaction Questionnaire (access, interpersonal manner and communication subscales) (Marshall GN, 1994) and The Survivors Unmet Needs Survey (access and continuity of care subscale) (Campbell HS, 2011)
GP Questionnaire - Satisfaction with communication (Jefford M, 2008).
Specialist and care coordinator questionnaire (satisfaction with communication and information shared)
Qualitative interviews with a sample of intervention participants (10 patients, 5-7 GPs and 3-5 specialists) by phone with a researcher at 9 months and 18 months post commencement of follow-up care for the delayed intervention group
Timepoint [2] 333121 0
9 months post commencement of follow-up care plus 18 months for the delayed intervention group
Secondary outcome [1] 415192 0
The provision of preventive, lifestyle and psychological care will be assessed by comparing patient reported preventive care, advice and referrals they have received in follow-up and provider perceptions on the care provided.
Methods
The survey will be administered at baseline and 9 months plus 18 months post commencement of follow-up care for delayed intervention group:
Patient Preventive Care survey - It utilises items from the National Health Survey which we have used in a previous study (Parker S, 2021)

Qualitative interviews with a sample of intervention participants (10 patients, 5-7 GPs and 3-5 specialists) by phone with a researcher at 9 months and 18 months post commencement of follow-up care for the delayed intervention group
Timepoint [1] 415192 0
9 months post commencement of follow-up care plus 18 months for the delayed intervention group
Secondary outcome [2] 415193 0
GP confidence in managing patients in follow-up will be assessed by comparing GP perceived confidence in managing various side effects of treatment.
Method
The survey will be administered at baseline and 9 months plus 18 months post commencement of follow-up care for delayed intervention group:
GP Questionnaire - Perceived confidence (Jefford M, 2008).
Qualitative interviews with a sample of GPs at 9 months plus 18 months for GPs in the delayed intervention group.
Timepoint [2] 415193 0
9 months post commencement of follow-up care plus 18 months for the delayed intervention group

Eligibility
Key inclusion criteria
Patients
- completed active treatment and less than 5 years post treatment for colorectal or breast cancer and identified by their cancer specialist as being suitable for shared follow-up care.
- have a regular GP who agrees to shared care.
- Must be 18 years or older

GPs
- who have a patient who has agreed to shared follow-up care.
- use electronic clinical records
- agree to the e-care plan connector software being installed at their practice.

Cancer specialists at St George Cancer Care Centre, the Nelune Comprehensive Cancer Centre, St George Private and Prince of Wales Private Hospitals who have breast and/or colorectal cancer patients
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients
- do not have a regular GP or the GP does not agree to participate in the study.
- Under the age of 18 years.
- receiving active cancer treatment
- not considered suitable for shared care by their cancer specialist
- completed active treatment greater than 5 years ago.
GPs
- do not use electronic clinical records or agree to the e-care plan connector software being installed

Study design
Purpose of the study
Prevention
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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size:
We aim to recruit 70 participants with 35 in the intervention and 35 in the comparison group. This is based on a sample size / power calculation for patient access and continuity of care. We assume an alpha 0.8 and beta 0.95 and non-inferiority of primary outcome measure; SUNS access and continuity subscale (based on mean 10.6 and SD 15.9 reported in Campbell et al 2011), a minimum detectable difference of 10, which gives a sample size of 32 in each group. An additional 10% loss to follow-up takes the sample size to 35 in each group.

Quantitative analysis
We will evaluate differences between the intervention and comparison groups using multivariate regression techniques at baseline. We will compensate for potential differences in the study population by including the following variables: age, sex, time since major active cancer treatment, centre type (private and public) and patient socioeconomic status (5 quintiles).

We will also examine change over time within each cohort group (intervention and comparison groups) and compare between groups using difference-in-difference analysis. We will adjust for age, sex, socioeconomic status and any independent variables that are significantly different between groups at baseline and use multiple imputation for missing values. Sensitivity analyses will assess unmeasured variation and data will be tested for and adjusted for clustering by GP.
We will analyse change in the delayed intervention group between receiving usual care at 9 to 12 months to receiving shared care at 18 to 24 months.

Qualitative analysis
We will use a realist approach to identify the mechanisms, barriers, enablers and contextual factors that influence adoption and implementation of shared e-care planning and conditions for sustainability and translation.

Mixed methods
We will explore using mixed methods the responses of both patients and providers to the intervention model and the variation between patients and providers who report differing levels of unmet needs and satisfaction.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/10/2022
Date of last participant enrolment
Anticipated
30/04/2023
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
70
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23460 0
St George Hospital - Kogarah
Recruitment hospital [2] 23461 0
St George Private Hospital - Kogarah
Recruitment hospital [3] 23462 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [4] 23463 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 38862 0
2217 - Kogarah
Recruitment postcode(s) [2] 38863 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 312522 0
Charities/Societies/Foundations
Name [1] 312522 0
Avant Foundation Ltd
Country [1] 312522 0
Australia
Primary sponsor type
University
Name
Centre for Primary Health Care and Equity, University of NSW
Address
University of NSW Sydney
High Street
Kensington
NSW 2052
Country
Australia
Secondary sponsor category [1] 314123 0
Hospital
Name [1] 314123 0
South Eastern Sydney Local Health District Cancer Services
Address [1] 314123 0
St George Hospital
Gray St, Kogarah NSW 2217,
Country [1] 314123 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311855 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 311855 0
Ethics committee country [1] 311855 0
Australia
Date submitted for ethics approval [1] 311855 0
Approval date [1] 311855 0
31/03/2022
Ethics approval number [1] 311855 0

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

Contacts
Principal investigator
Name 122614 0
Prof Mark Harris
Address 122614 0
Centre for Primary Health Care and Equity
University of NSW Sydney
High St
Kensington, 2052
Country 122614 0
Australia
Phone 122614 0
+61 2 93858384
Fax 122614 0
Email 122614 0
[email protected]
Contact person for public queries
Name 122615 0
Jane Taggart
Address 122615 0
Centre for Primary Health Care and Equity
Faculty of Medicine and Health
University of NSW Sydney
High St
Kensington
2052
Country 122615 0
Australia
Phone 122615 0
+61 2 90656738
Fax 122615 0
Email 122615 0
[email protected]
Contact person for scientific queries
Name 122616 0
Mark Harris
Address 122616 0
Centre for Primary Health Care and Equity
Faculty of Medicine and Health
University of NSW Sydney
High St
Kensington
2052
Country 122616 0
Australia
Phone 122616 0
+61 2 93858384
Fax 122616 0
Email 122616 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data from interviews and questionnaires that are not identifiable will be available for validation by other researchers if they have ethics approval.
When will data be available (start and end dates)?
Data will be available for 7 years after publications
Available to whom?
Other researchers who have ethics approval
Available for what types of analyses?
Validation
How or where can data be obtained?
By contacting the Principal Investigator Scientia Professor Mark Harris, [email protected]


What supporting documents are/will be available?




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.