Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000680268
Ethics application status
Approved
Date submitted
23/04/2018
Date registered
26/04/2018
Date last updated
12/02/2021
Date data sharing statement initially provided
11/06/2019
Date results information initially provided
12/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Centralised Specialist Cancer SurvivOrship (CISCO) Assessment Unit - an implementation study for transition to primary care
Scientific title
Develop Implement and evaluate a CentralIsed Specialist Cancer SurvivOrship (CISCO) Assessment Unit - to determine the feasibility, acceptability, and impact of transition to primary care for patients who have completed their cancer treatment.
Secondary ID [1] 292387 0
Nil
Universal Trial Number (UTN)
U1111-1199-0030
Trial acronym
CISCO Assessment Unit
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 303949 0
Condition category
Condition code
Cancer 303305 303305 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to implement a dedicated specialist-led clinic that will review patients who have completed their definitive cancer treatment, and workup a comprehensive, individually-tailored, survivorship care plan (SCP). This will consist of a single amalgamated document containing 1) a chronological summary of the patient’s cancer treatment (surgery, +/- adjuvant radiotherapy and/or any systemic therapies), 2) clear recommendations for the nature and timing of follow-up investigations, 3) a list of common potential clinical issues to watch for and management thereof, 4) recommended referrals to support services, and 5) relevant oncology team contacts.
The assessment process will be co-led by an oncology medical and nursing specialist. Referrals to the clinic will be electronic, and will be risk stratified based on pre-defined clinical risk, assessed by the treating Oncologist.
For this study, we will be commencing with early breast cancer or ductal carcinoma-in-situ patients who are completing post-operative radiotherapy and/or chemotherapy. Patients may be commencing endocrine therapy at the time of the CISCO Unit referral / assessment.

The SCP will be outlined for the patients’ GP to review and administer as necessary, with referrals to supportive wellness programs, psycho-social care or medical needs recommended, and information provided for ongoing tests, scans, follow-up schedules, as well as flagging any symptoms of concern and what to do if cancer recurrence is suspected. The assessment and/or SCP will be standardised but also individually-tailored, and built into Mosaiq, the hospital oncology electronic medical record (EMR).

The CISCO Assessment Unit will be set up as an implementation trial, and will include patient, clinician and GP feedback on the information provided, GP compliance to recommendations from the CISCO consultation and the written SCP, and a review of changes in the activity type in oncology (ie if there is a shift in the patterns of specialist follow-up). The study will evaluate the outcomes and assess the feasibility and efficacy of implementing this type of cancer survivorship clinic as standard practice.
Patients will be identified by their treating oncologist and/or breast nurse coordinator via clinic and/or Multi-Disciplinary Team (MDT) meeting lists to determine their eligibility to participate in the study, which will involve a referral to the CISCO Assessment Unit for a face-to-face consultation, which is ideally but not exclusively timed at the completion of definitive hospital-based treatment. the referral pathway to the CISCO Unit, incorporates a risk-stratified approach to screening and referral.

Once eligible patients are identified, research staff will then mail an information and consent pack to these patients and will telephone them 2 weeks later to confirm receipt of study materials, answer any questions about participation, and initially obtain verbal consent. Patients who return a signed consent form or who provide verbal consent when phoned by research staff will be booked to attend the CISCO Assessment Unit at the Liverpool Cancer Therapy Centre. Patients who are willing to participate will be mailed their CISCO Assessment Unit consultation appointment details and also sent an sms reminder regarding the appointment 2-3 days prior.
Patients who require more time to consider their participation will have the opportunity to consent at a later time and will be re-approached by phone 2 weeks later.
Consenting patients will also be mailed in hard copy, or emailed an on-line link, to enable completion of the PROMPT-Care assessment measures. The psychosocial measures and assessments used in the PROMPT-Care project encompass the following validated measures : the Distress Thermometer (DT), the Edmonton Symptom Assessment Scale (ESAS), the Supportive Care Needs Survey–Screening Tool 9 (SCNS-ST9), Fear of cancer recurrence (FCR) and the quality of life scale AQOL-8D.
In addition, to further characterise the study cohort, patients’ clinico-demographic, ECOG status, cancer and treatment details, as well as their treating oncology team and primary care practitioner, will be extracted from Mosaiq, the oncology EMR.

Patients will be asked to complete these assessments ideally in the week prior to their CISCO Assessment Unit consultation. Tablets will also be available at the clinic for patients to complete their PROMPT-Care assessment online immediately prior to their CISCO consultation, if they have not already completed their baseline measures. Research staff will be available to assist patients who need help completing these measures. The results of the patient’s assessment will be available to the care team in real time, to be addressed in that consultation. If required, interpreters will also be present at the face-to-face consultations. Family members / carers are also welcome to attend the clinic appointments upon request from the patient.

The CISCO Assessment Unit staff will include an experienced oncologist and cancer nurse coordinator who will jointly co-lead the Unit and oversee its processes and operations. At the appointment, each patient will consult sequentially with both the CISCO medical and nursing specialist, each with delegated issues to address which result from the patient’s PROMPT-Care assessment.

Patients will be booked to attend both an initial 1hr consultation and at least one 30minute follow-up consultation at the CISCO Assessment Unit, scheduled 6-12 months later, depending on the patient’s survivorship care trajectory and also designed to reflect scheduled recommendations eg timing of follow-up investigations contained within their SCP so that compliance with these recommendations can be assessed.

Patients will be surveyed immediately after both their initial and follow-up CISCO Assessment Unit consultations regarding their experience of the CISCO Assessment Unit and how well they thought their informational and psycho-social needs were addressed. A smaller sample of patients who have completed such surveys will be invited to participate in qualitative interviews either face-to-face or by phone, as per patient preference.

After the follow-up CISCO Assessment Unit consultation is completed, patients will be assessed for appropriateness for ongoing care to occur solely with their primary care practitioner, so long as the patient, their GP and their treating oncology specialists are agreeable.
Intervention code [1] 298561 0
Lifestyle
Intervention code [2] 300994 0
Rehabilitation
Intervention code [3] 301007 0
Treatment: Other
Comparator / control treatment
Nil. Current pathways for patients to continue follow up with their oncologist will remain. Referral to the new pathway will be with the consent of both the treating physician and the patient.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302687 0
The study aim is to collect cancer related symptoms as assessed using the Distress Thermometer (DT), Edmonton Symptom Assessment Scale (ESAS), and the Supportive Care Needs Survey screening tool 9 (SCNS-ST9), within our own integrated electronic patient reported outcomes survey tool - PROMPT-Care This is a composite outcome.
Timepoint [1] 302687 0
A link to this electronic tool will be sent to the participants for completion prior to the first clinic appointment, or if they do not have access to the internet, will be asked to attend 15 minutes prior to the clinic to use an ipad within the clinic to complete the surveys. This will be repeated at the follow up clinic, and at the point of follow up 1 month after the scheduled GP follow up.
Primary outcome [2] 305634 0
Patient compliance with survivorship care plan to ensure recommended follow up time points and recommended tests/scans are completed within the specified time points will be assessed via a follow up telephone survey designed specifically for this study,
Timepoint [2] 305634 0
1 month after recommended follow up with general practitioner.
Secondary outcome [1] 336748 0
GP acceptabiity of CISCO shared care model asses using a study specific questionnaire
Timepoint [1] 336748 0
Following evaluation and feedback analysis after 2 years of follow up care
Secondary outcome [2] 345978 0
Oncology Specialist acceptability of CISCO clinic model. using a study specific questionnaire.
Timepoint [2] 345978 0
assessed at 12 & 24 months into the study
Secondary outcome [3] 346042 0
Impact of CISCO clinic model will be measured by activity data within the oncology service, and a comparison of Oncologist casemix (ie new vs follow up patient appointments)
Timepoint [3] 346042 0
Before commencement of CISCO and at end of recruitment period.

Eligibility
Key inclusion criteria
• Histologically confirmed diagnosis of early breast cancer or Ductal Carcinoma in-situ (DCIS)
• Considered appropriate for the study as per their treating oncologist based on clinico-demographic, treatment and/or psychosocial characteristics.
• Have a nominated GP / primary care practitioner or practice.
-Patients who have completed radiotherapy or chemotherapy under a participating clinician at the trial site.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who are unable to complete study surveys / evaluation measures
• Patients with cognitive impairment precluding study consent and study measure completion
• Patients who have ongoing intensive hospital-based treatment planned

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)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This will be a prospective cohort study addressing the implementation of a cancer survivorship clinic for patients who have completed definitive therapy for their early breast cancer and/or ductal carcinoma-in-situ.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Overall, the potential benefits of the CISCO Assessment Unit will span the individual patient, their health care providers (both primary care and specialist), and the health service levels including the possibility for change in casemix activity. To measure these benefits, an evaluation framework will include measures at baseline and follow-up time points throughout the study, at an individual patient level, a health service provider level (both GPs and Specialists) and a health systems level.

Statistical analysis will include descriptive analyses to describe the clinical, ethno-demographic details, and cancer treatment received for the study cohort.
Results from the psychosocial screening and QOL measures will also be summarised for the study cohort overall.

Feedback from patient surveys and interviews will be analysed to measure patient acceptability.
Feedback from GPsurveys and interviews will be analysed to measure GP acceptability.
Feedback from Oncology Specialist surveys and interviews will be analysed to measure Specialist service acceptability.
Feasibility will be measured using acceptability, efficacy, compliance and health economic impact.
Analyses will be completed by the Project Officer under guidance and supervision of PI Koh.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/05/2018
Actual
20/04/2018
Date of last participant enrolment
Anticipated
30/08/2019
Actual
3/04/2020
Date of last data collection
Anticipated
30/04/2021
Actual
30/04/2020
Sample size
Target
120
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8498 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 16589 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 296937 0
Government body
Name [1] 296937 0
Cancer Institute NSW
Country [1] 296937 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Locked Bag 7103
Liverpool NSW BC 1871
Country
Australia
Secondary sponsor category [1] 295943 0
Hospital
Name [1] 295943 0
Liverpool Hospital
Address [1] 295943 0
Locked Bag 7103
Liverpool NSW BC 1871
Country [1] 295943 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298142 0
South Western Sydney Local Health District
Ethics committee address [1] 298142 0
Locked Bag 7103
Liverpool BC NSW 1871
Ethics committee country [1] 298142 0
Australia
Date submitted for ethics approval [1] 298142 0
03/07/2017
Approval date [1] 298142 0
03/04/2018
Ethics approval number [1] 298142 0
HREC/17/LPOOL/270

Summary
Brief summary
This study is evaluating a Centralised Specialist Cancer SurvivOrship (CISCO) Assessment Unit for people who have completed curative therapy.
Who is it for?
You may be eligible for this study if you have a histologically confirmed diagnosis of early breast cancer or ductal carcinoma and are completing or have recently completed chemotherapy and/or radiotherapy.
Study details
All participants will complete a series of questionnaires and have a consultation with a survivorship specialist team, who will provide information for ongoing cancer care and symptom management. Participants and their general practitioner will receive a care plan (called a survivorship care plan (SCP)) to easily manage their follow up care together. Supportive resources will be reviewed and pathways for contacting the oncology service will be established. Participants will be followed-up 6-12 months later and complete some questionnaires to evaluate the CISCO assessment unit.
It is hoped this study will establish the feasibility and acceptability of the CISCO model and improve the transition from cancer care to primary care for patients who have completed treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76138 0
Mrs Sandra Avery
Address 76138 0
SWSLHD Cancer Services
Locked Bag 7103
Liverpool NSW BC 1871
Country 76138 0
Australia
Phone 76138 0
+61 (02) 87389809
Fax 76138 0
n/a
Email 76138 0
[email protected]
Contact person for public queries
Name 76139 0
Dr Eng-Siew Koh
Address 76139 0
SWSLHD Cancer Services
Locked Bag 7103
Liverpool NSW BC 1871
Country 76139 0
Australia
Phone 76139 0
+61 (02) 8738 9806
Fax 76139 0
n/a
Email 76139 0
[email protected]
Contact person for scientific queries
Name 76140 0
Dr Eng-Siew Koh
Address 76140 0
SWSLHD Cancer Services
Locked Bag 7103
Liverpool NSW BC 1871
Country 76140 0
Australia
Phone 76140 0
+61 (02) 8738 9806
Fax 76140 0
n/a
Email 76140 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
confidentiality - only aggregated data is required to address the research questions


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.