RecruitingACTRN12624000110583

SOCRATES PILOT: Standard of Care Randomised Treatment Evaluation Studies


Sponsor

The University of Sydney

Enrollment

200 participants

Start Date

Aug 19, 2024

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When doctors face a medical condition where there are two or more equally good standard treatment options, it is often unclear which one works best for a given patient. The SOCRATES study is testing whether it is practical and acceptable to randomly assign patients to one of these equally valid treatment choices — instead of always leaving the decision entirely to doctor and patient preference — to gather better evidence about which options truly perform best. The study covers a wide range of conditions including certain cancers (such as prostate, breast, ovarian, and brain cancers), heart conditions (such as atrial fibrillation, heart failure, and post-heart attack care), and deep vein thrombosis. Participants can choose whether they want to be randomly assigned to a treatment or whether they prefer to choose their own standard treatment option in collaboration with their doctor. You may be eligible if you are 18 or older and have one of the listed conditions where at least two standard care options are available. This pilot study will help researchers understand whether this type of trial design is something patients and doctors are comfortable with.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(5)

Chris O’Brien Lifehouse - Camperdown

NSW, Australia

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

Concord Repatriation Hospital - Concord

NSW, Australia

Prince of Wales Hospital - Randwick

NSW, Australia

Royal Hospital for Women - Randwick

NSW, Australia

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ACTRN12624000110583


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