SMART Design: Cancer Symptom Alleviation by the Numbers

Mar 13, 2017

Surviving cancer comes with a burden of multiple symptoms (pain, fatigue, nausea, among others) triggered by the disease and its necessary medical treatments, often chemotherapy or radiation.  To feel better, cancer survivors search for symptom management strategies. But how do patients know what is or is not likely to work for them?  We gain such insights when scientists like University of Arizona College of Nursing Professor Alla Sikorskii, PhD, MS, set their minds to testing new therapies that are complementary to conventional medical ones (termed an integrative health approaches) in the newest possible ways. 

With a strong statistics background, Sikorski is well primed to lead her team to make the most of their Sequential Multiple Assignment Randomized Trial (SMART) design to test two integrative therapies with potential to improve symptom management in cancer patients. This might sound impenetrable to the layperson, but its simple intent is to improve the wellness of cancer patients.  Their approach goes beyond the often used traditional randomized controlled trial (RCT) whereby treatments are tested using a one-size-fits-all approach. We know, however, that rarely is one treatment equally effective in every person.  The SMART design allows for sequentially using more than one therapy and based on continual analysis of participant responses as the trial progresses, creating a ‘best fit’ of therapy to recipient. 
The upshot? Results will show which single therapy or additive therapies work best with people surviving cancer. Using her expertise in applied statistics, Sikorski revels in probing the data that will guide sequence of therapy exposure and ultimately reveal treatment plans that are better individualized for people.

Tell us about your current work?

SMART designs go beyond fixed predetermined interventions. Traditional clinical trials test a treatment to a comparison condition in order to determine how well it works on average. Because individual people differ in how well the treatment worked from completely to not at all, the results only indicate an average group effect and a summary measure of its variability.  So what do you do when people have little to no response to initial treatment? SMARTs test sequences of therapies that can reveal how to better tailor therapies and optimize individual outcomes.

What therapies are you testing?

We are testing the use of two integrative therapies, reflexology and meditative practice, in the home setting with the involvement of a friend or family caregiver. Whether it’s a spouse, partner or an adult child caring for a patient, they’re active participants in the study. Caregivers deliver reflexology to the survivors or practice meditation alongside them. We find that caregivers do not feel overwhelmed by an additional responsibility. They really want to help survivors, so by learning a technique such as reflexology they know they are helping to make a difference.

We begin by assigning participants to a single therapy (reflexology or meditative practice) and monitoring how well it works for people, and if it doesn’t work well, we then compare the effects of randomly assigning participants to groups of either more time with a single therapy or adding the second therapy. This innovative design is particularly exciting because it takes into account individual responses and makes adjustments based on responses for the sake of enhancing symptom reduction in individuals.

How are individual factors incorporated into the SMART?

When all the data are collected and analyzed, we will determine how to make optimal choices of one or two therapies to alleviate cancer survivors’ symptoms. We will take into account multiple factors which characterize the person and the disease, and home caregivers are a big part of the equation. As a result of data analysis, we will determine optimal treatments. For example, we can say ‘If this is a married couple let’s allocate them to reflexology first and see if it works and then make a decision whether or not to try meditative practices.’ For survivors and caregivers in different situations, we might decide that they should focus solely on meditative practice for the whole eight weeks.\

What implications could the results of SMART have for future cancer care?

It could have big implications, particularly when resources are limited. There are a variety of complementary therapies that can be employed in cancer care. As far as time, personnel and money goes, they are more or less costly. The therapies we chose to test can be practiced at home and can therefore be low cost, but depending on the person and context they could have varying effectiveness.   SMARTs have the potential to help identify who needs the most and who would do just fine with the least intensive therapeutic approach. All in all, the goal is to better assist cancer survivors alleviate symptoms and optimize wellness. 

Media contact: Jason Gelt, Communications and Content Specialist