TheraChoice Feasibility Study
We are very excited to announce that TheraChoice, our cancer treatment decision support tool, will soon be making its way into the hands of newly diagnosed prostate cancer patients. After many years of research and development, we are getting ready to run a feasibility study with a hospital-customized version of TheraChoice at the Princess Margaret Cancer Centre. We are collaborating with talented researchers and staff at the Prostate Centre, University Health Network (UHN), and University of Toronto’s Biomedical Communications. Our multi-disciplinary feasibility study team brings a different perspective, expertise, and skillset to the table:
- Researchers have great prowess and experience with academic research, REB submissions, study design, and more.
- Clinicians and hospital staff have immense knowledge about hospital procedures, patient experience, and the clinical perspective of prostate cancer.
- We (Bridgeable) leverage insights about the prostate cancer experience to design/iterate tangible solutions quickly.
Ultimately, we are developing this tool together to make the prostate cancer experience better.
A feasibility study is a mini-study to test the waters before going in for a deep dive. The objective of our feasibility study is to evaluate and analyze the viability of the TheraChoice tool in real clinical practice and identify any challenges or risks that we may face before launching a larger and more comprehensive clinical trial.
Through the study, we also hope to uncover the tool’s strengths and weaknesses and compare two tool interfaces relative to the standard of care (the Prostate Centre‘s current website). Some of the metrics that we are interested in comparing between the interventions and control include: prostate cancer knowledge, level of engagement, decisional conflict, and decisional satisfaction.
Transforming TheraChoice for the feasibility study
For the purposes of the study, we wanted to integrate TheraChoice into the existing Prostate Centre website as seamlessly as possible. For example, the original TheraChoice prototype was blue (colour used generally for prostate cancer) and included many circular motifs. The Prostate Centre’s website’s main colour palette is green and includes rectangles with rounded corners, so we updated the visual look accordingly.
Visuals aside, we also updated the medical content in TheraChoice to reflect the experience at the Prostate Centre. Changes included the treatment logic (according to clinical practice guidelines physicians adhere to at the hospital), the types of treatments available, the anticipated patient experience, etc. We felt that making the tool as specific as possible to the hospital was very important because individuals often enter the medical system blindly. With this specificity, we are able set up realistic expectations and the most probable sequence of events that a patient may encounter at the Prostate Centre.
Patients are expected to be responsible for their own care, however many have low levels of literacy when it comes to the medical system and the disease state they are entering.
We also built in tool functions to allow the feasibility study to run smoothly and to be managed remotely. We integrated new features such as unique account creation, automated intervention randomization, automated usage data collection, automated user progress saving, a front-end study coordinator dashboard (to track user progress, on a blinded basis), and more.
Preparing the research ethics board submission
It common for businesses to do research through focus groups or interviews. Since most of this research is kept private and away from the public eye, there is typically no governing body to control the processes of what you can and can not do. You reach out to individuals that you are interested in speaking to without much restriction.
By contrast, any academic research involving human participants at a hospital must be approved by the hospital’s research ethics board (REB). The REB application is an extremely detailed document about your research objectives, process, outcomes, etc. As a result, putting together a REB application can be seen as a big “obstacle” in the design world because it can slow down the iterative design process significantly.
Getting REB approval is our final step before we can launch the feasibility study with patients. A lot of work has gone into the REB submission so far; we have been working on our REB application for several months. It was quite a change of pace compared to the usual quick-turnaround projects that we are involved with. The “design/iterate” side of us is eager to get the tool into patients’ hands as soon as possible! On the flip side, we also realize that the REB submission itself is a document that has been discussed (the study design) and iterated over and over again. It is incredible how much detail is required in the application to ensure that we meet the standards of academic/scientific research.
For our collaborators, a successful REB application is extremely important to ensure that the research that we conduct is credible, comparable, and publishable in peer-reviewed journals. Running a feasibility study through REB also provides us with evidence and outcomes that will be regarded highly of by individuals in the medical community (and they love data)! We know that the quantitative and qualitative feedback that we receive from our feasibility study is going to be of high quality.
We are playing in the REB’s sandbox and it has been interesting to see what constraints the REB has in place. For example, we plan to ask a handful of patients to participate in an exit interview to wrap up the study. Even though these details are outlined in our consent form to participate in the study, the REB has told us that the exit interview requires additional consent because only selected patients will be asked to participate in the exit interview.
The UHN-REB oversees all research involving human subjects conducted under the auspices of the University Health Network to ensure that such research meets the highest scientific and ethical standards in order to protect patients, investigators and the institution.
The benefits of being involved
For us, being involved in a feasibility study is particularly important because implementation, uptake, and reliable distribution of credible electronic tools are some of the most challenging bottlenecks to get through in healthcare. A feasibility study provides us with the opportunity to have TheraChoice vetted and distributed by physicians to patients at the point of need ( immediately post-prostate cancer diagnosis), in a context that is similar to reality.
Everyone involved in the feasibility study can also benefit in the following ways:
For Bridgeable, this study provides us with a method to gather feedback and gain a better understanding of the patient experience of using electronic tools to navigate the prostate cancer journey. Afterwards, we can incorporate the feedback in further iterations of the tool. We are also learning a lot about the technical and academic nuisances of running randomized control trials in a clinical setting.
For physicians, this study provides evidence-based patient outcomes related to tool use. They can gain confidence in a credible and reliable hospital-specific resource, linked to evidence-based outcomes for patients. With the knowledge of this tool’s efficacy and existence, physicians can promote the tool as needed.
For researchers, evidence-based patient outcomes and study outcomes help advance research in the field of electronic tools and decision making. Logistically, the feasibility study will also reveal risks and challenges to mitigate if there is sufficient data to put towards a larger clinical trial design.
For patients and caregivers, the tool provides credible educational content with information that is more tailored to their situation, at the point of need.
Next time, we will share the feasibility study experience design for patients and researchers alike!