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Trial registered on ANZCTR


Registration number
ACTRN12624000110583
Ethics application status
Approved
Date submitted
16/10/2023
Date registered
8/02/2024
Date last updated
8/02/2024
Date data sharing statement initially provided
8/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
SOCRATES PILOT: Standard of Care Randomised Treatment Evaluation Studies
Scientific title
SOCRATES PILOT: Standard of Care Randomised Treatment Evaluation Studies
Secondary ID [1] 310698 0
CTC 0393
Universal Trial Number (UTN)
Trial acronym
SOCRATES PILOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 331623 0
Cardio Vascular Disease 331624 0
Condition category
Condition code
Cardiovascular 328500 328500 0 0
Coronary heart disease
Cardiovascular 328605 328605 0 0
Other cardiovascular diseases
Cardiovascular 328606 328606 0 0
Hypertension
Cancer 328607 328607 0 0
Brain
Cancer 328608 328608 0 0
Breast
Cancer 328609 328609 0 0
Cervical (cervix)
Cancer 328610 328610 0 0
Prostate
Cancer 328611 328611 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SOCRATES pilot study aims to assess the feasibility of randomising different Standard of Care (SoC) treatment options for a range of medical conditions. "Standard of care" refers to the treatment that a patient would usually be given for their health condition and is recommended by experts and scientific studies. There may be more than one SoC treatment for a medical condition. The medical conditions and SoC options included in this study are:

1) Recurrent glioblastoma
SoC 1. Lomustine alone
SoC 2. Bevacizumab alone

2) Non-metastatic castration-resistant prostate cancer
SoC 1. Darolutamide
SoC 2. Apalutamide
SoC 3. Enzalutamide

3) Metastatic castration-resistant prostate cancer
SoC 1. Abiraterone and prednis(ol)one
SoC 2. Enzalutamide

4) Metastatic castration-sensitive prostate cancer
SoC 1. Apalutamide
SoC 2. Enzalutamide

5) Maintenance PARPinhibitor for primary ovarian cancer with BRCA mutation
SoC 1. Olaparib
SoC 2. Niraparib

6) Adjuvant Treatment for ER+ early breast cancer in post-menopausal women
SoC 1. Letrozole
SoC 2. Anastrozole

7) HER2-negative advanced breast cancer after failure of anthracycline
SoC 1. Paclitaxel
SoC 2. Nab-Paclitaxel

8) Deep vein thrombosis (DVT)
SoC 1. Rivaroxaban
SoC 2. Apixaban

9) Post Myocardial Infarction (MI)
SoC 1. Cardiac rehab via telehealth
SoC 2. Cardiac rehab in person

10) People with office BP>120/80 and <150/90 in the setting of primary prevention of cardiovascular disease (CVD)
SoC 1. Changes to lifestyle (nutrition, physical activity and smoking status)
SoC 2. BP lowering medications (any ACE inhibitor or Angiotensin II receptor blocker, dose discretionary)

11) Non-valvular atrial fibrillation
SoC 1. Rivaroxaban
SoC 2. Apixaban

12) Previous Myocardial Infarction (MI)/Stroke
SoC 1. Atorvastatin
SoC 2. Rosuvastatin

13) Heart Failure with Reduced Ejection Fraction (HFrEF) without Diabetes mellitus (DM)
SoC 1. Empagliflozin
SoC 2. Dapagliflozin

14) Hospital admission with first episode paroxysmal Atrial Fibrillation (AF)
SoC 1. Metoprolol
SoC 2. Sotalol

Participants will discuss the SoC options for their medical condition with their doctor. If the doctor recommends more than one SoC option for this participant, they would be invited to participate in the Study. Based on their own preference, participants will either have their SoC option determined by randomisation (randomised cohort) or they will choose their SoC option in consultation with their doctor (non-randomised cohort).

The randomized cohort is the 'intervention' group for SOCRATES pilot study.

The recruitment period is of two years. Each recruited study participant will be followed up for twelve months post registration to the study.
Intervention code [1] 327189 0
Treatment: Other
Comparator / control treatment
Non-Randomised cohort is the 'control' group for SOCRATES pilot study. Participants in the non-randomised cohort will directly choose their SoC option in collaboration with their doctor.
Control group
Active

Outcomes
Primary outcome [1] 336316 0
The willingness of participants to be randomised to a SoC option for their medical condition as specified in "section 3 Intervention/exposure" of this registration form.
Timepoint [1] 336316 0
The willingness to participants to be randomised to a SoC option will be assessed at the registration into the study
Primary outcome [2] 336317 0
The willingness to participate in the randomised cohort or the non-randomised cohorts among those invited.
Timepoint [2] 336317 0
This will be assessed for each participant at the registration into the study
Primary outcome [3] 336318 0
How participants felt about the option to have their treatment randomised (SOCRATES Feedback Survey).
Timepoint [3] 336318 0
This will be assessed at Baseline and 6 months post participant consent.
Secondary outcome [1] 430242 0
Adherence to Assigned SoC
Timepoint [1] 430242 0
This will be measured for each participant by clinician assessment of treatment adherence at 6 and 12 months (if available) post participant consent.
Secondary outcome [2] 430243 0
The feasibility of collecting required baseline and outcome data. This is a composite outcome, feasibility of collecting required baseline data (i.e. completeness of required baseline data) is relevant to determining the outcome.

This will be measured for each participant by the completeness of data available in their medical record to determine the outcome (including treatment success, treatment side effects) for their particular medical condition. As discussed in UAT meetings, specific fields will be deemed mandatory and the completeness of these fields only will be used to assess feasibility.
Timepoint [2] 430243 0
This will be assessed at Baseline, 6 months and 12 months post participant consent.

Eligibility
Key inclusion criteria
1. Adults, aged 18 years and older.
2. Have one of the defined medical conditions as listed in 'Step 3: Intervention/exposure' of this Registration Form.

Medical conditions:
1) Recurrent glioblastoma
2) Non-metastatic castration-resistant prostate cancer
3) Metastatic castration-resistant prostate cancer
4) Metastatic castration-sensitive prostate cancer
5) Maintenance PARPinhibitor for primary ovarian cancer with BRCA mutation
6) Adjuvant Treatment for ER+ early breast cancer in post-menopausal women
7) HER2-negative advanced breast cancer after failure of anthracycline
8) Deep vein thrombosis (DVT)
9) Post Myocardial Infarction (MI)
10) People with office BP>120/80 and <150/90 in the setting of primary prevention of cardiovascular disease (CVD)
11) Non-valvular atrial fibrillation
12) Previous Myocardial Infarction (MI)/Stroke
13) Heart Failure with Reduced Ejection Fraction (HFrEF) without Diabetes mellitus (DM)
14) Hospital admission with first episode paroxysmal Atrial Fibrillation (AF)

3. Be considered suitable – by their responsible clinician - for at least 2 SoC options for this condition based on evidence-based guidelines or other appropriate documentation listed in 'Step 3: Intervention/exposure' of this Registration Form.
4. Give informed consent to either be assigned a SoC option (randomised cohort) or receive their chosen SoC option (non-randomised cohort) and to have routinely collected clinical outcome information in their medical record made available in a de-identified manner centrally for the study.
5. Consent to simple web-based questionnaire follow-up (not compulsory).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to provide informed consent.
2. Contraindication to any of the nominated SoC options.

Study design
Purpose of the study
Treatment
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25728 0
Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 25729 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 25730 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 25731 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 25732 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 41555 0
2031 - Randwick
Recruitment postcode(s) [2] 41553 0
2050 - Camperdown
Recruitment postcode(s) [3] 41552 0
2050 - Missenden Road
Recruitment postcode(s) [4] 41554 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 314914 0
Government body
Name [1] 314914 0
National Health Medical Research Council
Country [1] 314914 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
92 Parramatta Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 317037 0
None
Name [1] 317037 0
Address [1] 317037 0
Country [1] 317037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313907 0
SLHD Ethics Review Committee (RPA Zone)
Ethics committee address [1] 313907 0
Research Ethics and Governance Office (REGO) Royal Prince Alfred Hospital Missenden Road CAMPERDOWN NSW 2050
Ethics committee country [1] 313907 0
Australia
Date submitted for ethics approval [1] 313907 0
27/09/2023
Approval date [1] 313907 0
05/12/2023
Ethics approval number [1] 313907 0
X23-0373 & 2023/ETH02094

Summary
Brief summary
The SOCRATES pilot study aims to assess the feasibility of randomising different Standard of Care (SoC) treatment options for a range of medical conditions listed below.
1) Recurrent glioblastoma
2) Non-metastatic castration-resistant prostate cancer
3) Metastatic castration-resistant prostate cancer
4) Metastatic castration-sensitive prostate cancer
5) Maintenance PARPinhibitor for primary ovarian cancer with BRCA mutation
6) Adjuvant Treatment for ER+ early breast cancer in post-menopausal women
7) HER2-negative advanced breast cancer after failure of anthracycline
8) Deep vein thrombosis (DVT)
9) Post Myocardial Infarction (MI)
10) People with office BP>120/80 and <150/90 in the setting of primary prevention of cardiovascular disease (CVD)
11) Non-valvular atrial fibrillation
12) Previous Myocardial Infarction (MI)/Stroke
13) Heart Failure with Reduced Ejection Fraction (HFrEF) without Diabetes mellitus (DM)
14) Hospital admission with first episode paroxysmal Atrial Fibrillation (AF)


"Standard of care" refers to the treatment that a patient would usually be given for their health condition and is recommended by experts and scientific studies. There may be more than one SoC treatment for a medical condition.

Who is it for?
You can participate in this study if your medical condition is listed above and there is more than one standard of care options available for your health condition. Based on your own preference, you will either be a member of the randomised cohort or the non-randomised cohort. Participants in the randomised cohort will have their SoC option specified by a randomisation system. Participants in the non-randomised cohort will directly choose their SoC option in collaboration with their doctor.

The study will also collect information on participant's experiences receiving the SoC option, as well as collect information on outcomes associated with the treatment they receive. The study plans to enrol approximately 200 participants in Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129746 0
Prof John Simes
Address 129746 0
NHMRC Clinical Trials Centre, 119-143 Missenden Rd, Camperdown NSW 2050
Country 129746 0
Australia
Phone 129746 0
+61 2 9562 5002
Fax 129746 0
Email 129746 0
john.simes@sydney.edu.au
Contact person for public queries
Name 129747 0
Ms Deepa Mathur - SOCRATES PILOT Trial Operations Coordinator
Address 129747 0
NHMRC Clinical Trials Centre, Locked Bag 77, Camperdown NSW 1450
Country 129747 0
Australia
Phone 129747 0
+61 2 8036 5295
Fax 129747 0
Email 129747 0
socrates.study@sydney.edu.au
Contact person for scientific queries
Name 129748 0
Prof John Simes
Address 129748 0
NHMRC Clinical Trials Centre, 119-143 Missenden Rd, Camperdown NSW 2050
Country 129748 0
Australia
Phone 129748 0
+61 2 8036 5295
Fax 129748 0
Email 129748 0
john.simes@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is de-identified and presented as a summary of results rather than individual participant data.


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.