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Trial registered on ANZCTR


Registration number
ACTRN12617000004369
Ethics application status
Approved
Date submitted
1/12/2016
Date registered
3/01/2017
Date last updated
18/03/2020
Date data sharing statement initially provided
18/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of a shared-care model of follow-up for survivors of colorectal cancer.
Scientific title
Shared care of Colorectal cancer survivors - A randomised controlled trial of hospital-based follow up versus shared hospital / community follow up for survivors of colorectal cancer
Secondary ID [1] 290622 0
NIL
Universal Trial Number (UTN)
U1111-1190-3503
Trial acronym
SCORE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unmet needs 301125 0
Colorectal cancer 301126 0
Condition category
Condition code
Cancer 300894 300894 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 301107 301107 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a shared care model where 2 of the 4 routine hospital visits in the year after end of treatment (EOT) are replaced by GP visits (30 minutes) at the 3 and 9-month post EOT. An additional GP visit at 2 weeks post-EOT is included to discuss the follow up plan and establish common ground about the model of shared care. The following core elements will support shared care:
1. Survivorship care plan (SCP). The SCP is tailored to each participant by the research team which may include a nurse, research assistant and/or data manager and comprises a summary of the patient's diagnosis of treatment, recommendations for follow up and strategies to remain well. The patient and GP will receive copies.
2. GP clinical management guidelines. Guidelines are in line with the Australian Cancer Network Colorectal Cancer Guidelines and recommendations from the American Cancer Society of Clinical Oncology and include guidance about tests to detect recurrence, possible late and long-term effects of treatments and how to manage these, as well as how to re-refer patients to a rapid review clinic.
3. Assessment will be based on issues frequently encountered by cancer survivors (e.g. fatigue, fear and cancer recurrence) and issues experienced by colorectal cancer survivors (e.g. bowel disturbance, sexual problems).
Intervention code [1] 296497 0
Other interventions
Comparator / control treatment
The control is care according to current practice, consistent with national and international guidelines. Usual care consists of 4-routine hospital-based visits and includes taking patient history, performing a physical examination and blood tests for carcinoembryonic antigen (CEA) testing at 3, 6, 9 and 12-months post-EOT.
Control group
Active

Outcomes
Primary outcome [1] 300380 0
Patient Quality of Life as measured by the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ CR30) together with the European Organisation fro Research and Treatment of Colorectal Cancer Module (EORTC QLQ CR-29).
Timepoint [1] 300380 0
Baseline, 6-month and 12-month follow-ups.
Secondary outcome [1] 329842 0
Cost benefit analysis as measured by comparing the intervention resource costs against Medicare data on doctor visits.
Timepoint [1] 329842 0
End of Study.
Secondary outcome [2] 329843 0
Assessment of patient perceived satisfaction, accessibility and convenience of the intervention using the The Short-form Patient Satisfaction questionnaire (PSQ-18).
Timepoint [2] 329843 0
Baseline, 6-month and 12-month follow-ups.
Secondary outcome [3] 329844 0
Assessment of patient perceived experience of oncology care using the Picker Ambulatory Oncology survey.
Timepoint [3] 329844 0
Baseline, 6-month and 12-month follow-ups.
Secondary outcome [4] 329845 0
Assessment of patient unmet needs using the Short-Form Survivor Unmet Needs Survey (SF-SUNS).
Timepoint [4] 329845 0
Baseline, 6-month and 12-month follow-ups.

Eligibility
Key inclusion criteria
Patients eligible for this study include:
- A confirmed diagnosis of colon or rectal cancer
- Stage I-III disease
- Must have completed treatment with curative intent at one of the participating sites within the previous 3-months.
- Over 18 years of age;
- Able to read and write English; and
- Has a GP willing to participate in the study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not eligible for this study include:
- Demonstrated cognitive or psychological difficulties that would preclude the study participation
- Too unwell to participate in the study
- Treated from a previous cancer (except non-melanoma skin cancer)
- Has a GP already participating in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
For each site, a research team will be appointed. This may include a nurse, research assistant and/or data manager. The research team will screen cancer patients and identify eligible patients from the Gastro-Intestinal (GI) outpatient and chemotherapy, surgery and radiotherapy lists, with the assistance of GI unit clinicians. Eligibility will be confirmed with the treating clinician prior to approaching any patients to clarify any details from the medical records, and to ensure the clinician is aware of the patient’s involvement with the study. If a patient is considered too unwell by his/her treatment team to participate in the study at the time of initial screening, the patient may be approached at a later date consistent with the study’s specified recruitment time frames.

Once it has been established that a patient is potentially eligible for the project, the research team will approach the patient to explain the project in detail and answer any questions. If the patient wishes to participate, the Participant Information and Consent Form will be provided and consent obtained. Patients will also be asked to provide consent for access to their Medicare Australia data and hospital records. Following the initial discussion, the patient’s preferred GP will be contacted to confirm eligibility and willingness to be involved in the research study should the patient be randomised to the intervention arm. An opt-out approach will be used in this instance. If the GP returns the form noting that they prefer not to be a part of the study, no further contact will be made. If the GP contacts the research team stating they would like to take part or if the form is not returned within one week, consent to take part in the study will be implied.

Patients who decline to take part in the research study will be asked for their verbal consent to collect basic demographic and clinical information from their records to examine potential recruitment bias. Reasons for refusal will be recorded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The research team at the Coordinating site will randomly allocate patients to either usual care or the shared care using centralised randomisation database.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7049 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 7050 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [3] 7051 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [4] 7052 0
Western Hospital - Footscray
Recruitment hospital [5] 7053 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 14777 0
3000 - Melbourne
Recruitment postcode(s) [2] 14778 0
3052 - Parkville
Recruitment postcode(s) [3] 14779 0
3065 - Fitzroy
Recruitment postcode(s) [4] 14780 0
5022 - Henley Beach
Recruitment postcode(s) [5] 14781 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 295100 0
Government body
Name [1] 295100 0
Victorian Cancer Agency
Address [1] 295100 0
50 Lonsdale St, Melbourne, Victoria, 3000
Country [1] 295100 0
Australia
Funding source category [2] 305273 0
Government body
Name [2] 305273 0
Cancer Australia
Address [2] 305273 0
Level 14, 300 Elizabeth Street, Surry Hills NSW 2010
Country [2] 305273 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street, Melbourne, Victoria, 3000
Country
Australia
Secondary sponsor category [1] 293918 0
None
Name [1] 293918 0
Address [1] 293918 0
Country [1] 293918 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296451 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 296451 0
305 Grattan Street, Melbourne, Victoria, 3000
Ethics committee country [1] 296451 0
Australia
Date submitted for ethics approval [1] 296451 0
28/11/2016
Approval date [1] 296451 0
15/12/2016
Ethics approval number [1] 296451 0
HREC/16/PMCC/89

Summary
Brief summary
The study is evaluating the potential of a shared-care model of follow-up for survivors of colorectal cancer.

Who is it for? You may be eligible to join this study if you are aged 18 years or more, have a confirmed diagnosis of colon or or rectal cancer at stage I-III, completed treatment with curative intent within the past 3-months at one of the participating sites and have a GP willing to participate in the study.

Trial details: Participants in this trial are randomly (by chance) allocated to one of two groups. Participants in Group 1 will receive usual care according to current hospital practice. Participants in Group 2 will receive shared-care between specialist and general practitioner in which two routine hospital appointments will be replaced by GP appointments. In addition participants in Group 2 will receive a tailored survivorship care plan with care guidelines detailing information and recommendations about common concerns after treatment with additional support services information. Once the survivorship care plan is complete the patient will receive a written copy, with a copy provided to the patients preferred General Practitioner (GP). This is to ensure that the GP is familiar with the issues the patient is working on and can provide ongoing assistance as necessary. All participants will be asked to complete some questionnaires at the start of the study, and 6 and 12 months later in order to assess unmet needs, perceived experience of oncology care, satisfaction of the intervention and quality of life. Feasibility and cost-effectiveness of the two interventions will also be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70758 0
Prof Michael Jefford
Address 70758 0
Peter MacCallum Cancer Centre,
305 Grattan Street, Melbourne, Victoria, 3000
Country 70758 0
Australia
Phone 70758 0
+61 3 8559 5910
Fax 70758 0
+61 3 8559 5909
Email 70758 0
score@petermac.org
Contact person for public queries
Name 70759 0
Mr Mustafa Mohamed
Address 70759 0
Peter MacCallum Cancer Centre,
305 Grattan Street, Melbourne, Victoria 3000
Country 70759 0
Australia
Phone 70759 0
+61 3 8559 7844
Fax 70759 0
+61 3 8559 5909
Email 70759 0
mustafaabdi.mohamed@petermac.org
Contact person for scientific queries
Name 70760 0
Prof Michael Jefford
Address 70760 0
Peter MacCallum Cancer Centre,
305 Grattan Street, Melbourne, Victoria 3000
Country 70760 0
Australia
Phone 70760 0
+61 3 8559 5910
Fax 70760 0
+61 3 8559 5909
Email 70760 0
Michael.Jefford@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethics approval, and participant did not consent to for IPD o be publicly available.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 7387 0
Study protocol
Citation [1] 7387 0
Jefford, M., Emery, J., Grunfeld, E. et al. SCORE: Shared care of Colorectal cancer survivors: protocol for a randomised controlled trial. Trials 18, 506 (2017). https://doi.org/10.1186/s13063-017-2245-4
Email [1] 7387 0
Michael.Jefford@petermac.org
Other [1] 7387 0
Attachment [1] 7387 0
Summary results
No Results