The trial group is hoping it will give regional patients more access to its latest trial.
Breast Cancer Trials (BCT) is taking its latest trial recruitment to the regions using telehealth.
It hopes it will remove some of the barriers to women accessing the benefits they might gain from this trial, and to find the people this treatment is most likely to help.
“Breast cancer treatment is becoming increasingly individualised, where we aim to precisely target the specific features of an individual’s breast cancer to give them the most effective treatment with the fewest side effects,” said Dr Sarah Zardawi, clinical fellow at Breast Cancer Trials in Newcastle.
“The OLIO remote telehealth project aims to make it easier to test a greater number of women to see if the OLIO trial is right for them by allowing the pre-screening to be done via telehealth without the need for the patient to travel to a trial site.”
The largest independent oncology clinical trials group in Australia and New Zealand is looking for 56 people to join the trial, which aims to improve treatment for young women with high-risk hormone receptor positive Her-2 negative cancer by adding a PARP inhibitor (the drug olaparib) to standard chemotherapy, with or without an immune checkpoint inhibitor (durvalumab).
The treatment targets a particular feature of the tumour – homologous recombination deficiency (HRD). Participants need to have a tumour with that molecular characteristic, and it’s expected that only one in five women tested will fit the bill.
Normally, patients would have to travel to trial sites even for this initial step, which can involve a big investment of their time and money.
With the remote telehealth pre-screening process, the first steps can be taken in a patient’s home, or at their GP surgery.
Patients who might be eligible would need to be referred to BCT’s central investigator by their usual oncologist.
They would then have a telehealth consultation where the trial would be explained, their questions would be answered, and they would be asked if they consented to a pre-screening procedure.
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The pathology test, which can be provided by BCT, is administered locally and analysed at a central laboratory.
The patient has another telehealth consultation with the BCT Central Investigator to learn their results. If they are eligible for the trial, their treating oncologist will refer them to the nearest trial site for discussions with the team and to decide if they want to be on the trial.
Those who enter the trial can also have some of their weekly treatments and post treatment checkups with their local oncologist.
“Patients who live in regional and rural areas often have less access to medical care (including clinical trials… This is one factor contributing to poorer health outcomes including poorer cancer outcomes. All patients with breast cancer deserve quality medical care which includes the opportunity to participate in clinical trials,” said Dr Zardawi.
In addition to the personal benefit to patients, the researchers hope to be able to reach a wider, more representative section of the community by opening up pre-screening to more people.
“It is important that the patients in clinical trials represent the broader patient population in terms of geography, ethnicity and socio-economic factors so that we know that treatments actually work for all patients and not just some portions of the population. We hope that by improving access there will be more rural patients on the OLIO trial and the results of the OLIO trial will be more accurate for application to the real-world patients.”