I will be talking about findings from a multisite national clinical trial that was conducted in the United States through the National Institutes of Health University of Rochester Cancer Center Community Oncology program focusing very specifically on the individuals who participated in the study, which was a total number of 716, how they completed patient-reported outcome forms. So were they able to do that independently or did they require some assistance in completing those forms.

What was the study design?

I think I just mentioned that this was based on a national study that was a randomised clinical trial and it was a cluster randomised so the practice sites were randomised. All of the patients participating received a geriatric assessment but only those randomised to the intervention had geriatric assessment with management recommendations provided to the oncologist. It’s called the GAP70+ study and the PI of that study was Dr Mohile. My analysis was a sub-analysis, not the primary aim, that was looking at a specific question.

What were the results and what might their significance be?

So we know that it’s very important to incorporate the patient’s voice when we’re doing cancer clinical trials. We do it not only in practice but also when we’re doing research. So my study was looking at one of the barriers when we have a lot of questionnaires that patients can complete, especially older adults. In this study, to be included you actually needed to have advanced cancer, so those individuals may have been more frail or more symptomatic because of the status of their disease. We know that a barrier sometimes can be completing those forms if they have, for example, visual problems and can’t read the forms or something of that nature.

We collected data at four different timepoints and we found that at the very initial timepoint actually 41% of the people participating in this study received assistance, most commonly from the clinical research associate that was involved in the study or from a family member. But that changed over time so that those individuals who needed help at the first timepoint, over the course of the six months only 29% were requiring any assistance.

Then we also examined what characterised those individuals who were more likely to get help filling out the form versus those individuals who were able to do the form independently. It’s probably important to say that this study, the forms were filled out in pen and paper, it wasn’t digital and it wasn’t electronic, it was the old-fashioned pen and paper filling out the form. Most of the timepoints there were 8-11 different pages and most of what needed to be filled out was either circling a response or filling in something. So patients didn’t need to write down a lot of information. Nonetheless they still did receive assistance in completing those forms.

When we looked to see what was different about the people who needed assistance versus those who were able to complete it independently was we found those individuals with a higher level of educational attainment most often did not require help. The odds ratio on that was they were four times more likely to be able to do it independently. Then the other very interesting finding was using the tool of geriatric assessment which identifies potential risk factors of vulnerabilities, those individuals who had changes or risk identified from the geriatric assessment were the people more likely to get help. So specifically if they had visual problems they were more likely to need help, kind of self-evident but important to know. Also if they had any alteration in their cognitive status they were more likely to receive help. Similarly, if they had changes in their activities of daily living. So the risk factors that identified those individuals who need help are often incorporated and found through the process of geriatric assessment.

Now, what’s the significance of those results? When we’re planning to do research or even integrating this into our practice and we want to ask patients for their input and to fill out forms, or give us information about their health status, what we need to do is plan, that’s the main take-home message. So if you plan ahead so you can allocate budget or staffing resources or even have a protocol in place so that the first time you’re asking individuals to give you that information, you provide assistance to them so they understand what it is they need to do to help.

Is there anything else you would like to add?

I can tell you that in an earlier study that we conducted we actually asked these questions and it was with a similar type of population – older adults over the age of 70. But the results I just talked to you about were for people who were actively receiving systemic treatment, most commonly chemotherapy, and the average age of those individuals was 77 years. In a similar study, it’s called the COACH study, we also looked at this and found 28% of individuals received help. So a lower percentage but still up to 3 in 10 patients or 4 in 10 patients if you’re planning to collect that information may need assistance or at least at the initial visit. But what the two shared in common was the factors that identified who needed help were the same in both.

I guess the only other message I would say is how very important and critical it is to make sure we include the patient’s voice in understanding how they’re feeling and how they’re functioning while they are dealing with their cancer treatment and/or effects of disease. So making sure we have the resources available to collect this information is very important.

I’d just like to thank all of the members of the research team at the University of Rochester, the geriatric oncology team and the URCC, [?? 7:33] and all of my colleagues in getting the work done. And I’d like to thank SIOG for concentrating on the international issue of older adults with cancer and making sure we have the right evidence and information so we can take care of them the best way we can.