Side Effect Severity & Decision-Making Autonomy in Myeloma | Jay Hydren, PhD, CSCS | #ASH24

Hello, I'm Dr. Jay Hydron. I'm the Senior Director of Clinical Research at Health Tree Foundation. And we're really excited at ASH because we had 11 abstracts accepted, two as orals and four as posters. And I'm going to talk to you about one of our oral presentations right now on patient centered care and hematology, how side effect severity influences decision making, autonomy and relapse refractory multiple myeloma. It's really important for us to understand how different patient groups make their decision making so that we can give them the best resources possible when they need it, when they're getting ready for a change in treatment decision. So this focused on understanding patients perceptions and decision making process during their second line or third line plus treatment change. The scope of the study was quite large. We had 174 factors we looked at covering 11 domains which included treatment related factors, patient related factors, myeloma disease related factors, education awareness and understanding, educational resources, who patients discusses option with, their comfort in their final decision, clinical decision making experience, clinical trial considerations, doctor patient relationships and decision making in the age of all these new therapies. On this study we had 784 patients participate. Of those, 333 had a relapse and were part of the study. So this part is really important how we looked at the data where 54% rated side effects as extremely or very influential whereas 46 reported them as somewhat slightly or not and that's how we broke down and looked at these responses. The demographics were largely the same except for gender and the very in extremely group was 60% female and the SSN group were slightly somewhat not it was 47%. The level of understanding of the likely side effects was higher than the group that was very extremely influenced and this was related to our measure of side effect severity with an R value of .16 which is a significant relationship but weak. In a similar comparison the R value is about .2 when we looked at the relationship between the level of efficacy and side effect balance with their influence of side effect severity and treatment decision making. The factors that were higher influence in the treatment related group included treatment frequency, availability, time in clinic, supportive care requirements and if the FDA approved the drug or if it was an experimental therapy. Patient related factors the number one of course is quality of life followed by ability to take care of myself during treatment, existing health conditions that could be made worse, emotional state and anxiety and out of pocket costs or their financial status and these were all higher in that very extremely group. Additionally ability to continue working on treatment and willingness to travel to a treatment center, ability to take care of others and daily responsibilities and their current frailty or physical ability were also higher in this VE group. Their myeloma disease related factors that were higher in the VE group included ability to concentrate and focus and severity of the myeloma related symptoms overall. The VE group engaged their family and friends more and had more conversations with fellow patients about what they would likely go through before making their decision. The doctor patient relationship was more engaged in the very extremely group. They were more likely to answer questions like my doctor makes recommendations, I ask questions and we discuss my preferences, purpose, ideas and I make the final decision. The SSN group left more of that decision making power in the doctors hands and then we asked the patients who really made that final decision. We gave them three options, the patient, the doctor or as a joint. The joint was actually less than 1%. In the very extremely group 66% of patients feel like they're making that final decision versus 52 and the slightly somewhat or not group and it's a reciprocal for when the doctor made the decision. And interestingly your fellow patients that are very extremely influenced by side effects are using pharmaceutical companies informational resources at a much higher rate about one out of four in the VE group versus about one out of ten in the somewhat slightly or not group. The very extremely group are given more time to get to this decision. It was about 4.8 weeks in the VE group versus 3.3 weeks in the SSN group and patients use more time in the VE group with 2.5 weeks versus 1.4 so they use a whole week longer to get to the treatment decision. Interestingly when we looked at what are the trade-offs patients are willing to make to have a treatment decision there's no observed difference meaning patients that are very concerned about the side effect profile are willing to make the same trade-offs as those that aren't as influenced. When it comes to clinical trials we did find a small group of patients when we looked at patients that considered a clinical trial but didn't participate in the very extremely group some did say that they were uncomfortable with possible unknown side effect profiles in the clinical trial where the patients that weren't as influenced by this didn't report this as a reason. So in conclusion patients that are very extremely influenced by side effects are high information decision making patients that really want to understand discuss what the treatment options are with their peers their providers and family. They're given more time about one week more to get to that decision and they use an extra week personalized education really matters they really want to understand that side effect profile the impact that's going to have on different aspects of their quality of life and they have more of this shared decision making experience. We really hope this research will help the clinical providers and patient advocacy groups that provide education to patients and peer to peer connections really value and understand the importance of about half of patients who are very influenced by the side effect profile they may have. Thank you very much if you did participate in the study we have many more if you haven't and we really want to thank Ash for accepting this as an oral presentation. So when we look at the continuum of side effects severity it goes from not important at all to extremely or very and there is a bell curve there what we decided to do was cut it in half so we can really understand if there are significant which means that these populations might be different in how they engage and get to that final decision which is really important when you're talking with a fellow patient who might be going through an experience that you went through or if you're asking about that that you shouldn't feel alone that you're not the only one that's really trying to get to this high information decision point. There's several patients that go in the clinic and they just say, Doc what do you think is the best for me and they just choose it and they don't want to get into the details. Maybe they have anxiety about understanding their disease more they want to not think about it and then the other side there's people that are caregivers to other people in their family and or they're in the workforce they need to maintain their insurance and they really need to have a high quality of life so that they can perform in their career and with their family and those patients are very concerned of what this treatment may affect that and deteriorate that and there's a spectrum of patients. Understanding when you're in a conversation with a patient if they're on this continuum they really might want to have really deep conversations or they might not and when we tell our education and think about that individualized patient experience this gives us some insight of where we can focus our energy more. In the clinic if a patient seems to be this high information decision maker they really want to give them those extra resources and point them towards other advocacy groups or maybe even Health Tree where they can get the resources they need and get comfortable. They're willing to make the trade-off if they need it that's what the data showed us but before they make that decision they really want to understand and get their kind of ducks in a line for that change in their life under that therapy and in myeloma we have CAR T we have transplant we have bi-specifics we looks like we have antibody drug conjugates coming we have monoclonal antibodies all those have different modes different frequencies different availability geographically and different side effects and different recoveries so for patients they really want to understand which one is going to be best for them in their moment in their cancer journey. This data set was so comprehensive where we kind of want to go next with this is make sure we capture the patient experiences in each of these therapies so we have high quality real-world data available for over half of patients that are interested in using that in their decision making so we have a three-year bi-specific study a three-year CAR T study we're gonna have to really look at this new drug class of antibody drug conjugates and collect some data there as well and of course we're on top of daratumum and understanding that. And Cure at Health Tree this data set told us that we've built out all these wonderful guides and HTU but we need to build out the real-world data set so we have real solid evidence of what the true experience is.