Challenges to the design and testing supportive interventions for cancer patients treated with oral oncolytic agents

Abstract

Conducting research into supportive care for patients as they initiate treatment with oral oncolytic agents poses numerous new challenges. Some of these medications have very complex dosing schedules and produce symptoms that patients need to manage at home with less reliance on oncology clinicians. We describe lessons learned from a multi-site trial designed to improve adherence to these medications and self-management of symptoms among patients newly prescribed oral oncolytic agents. Identifying these challenges can assist researchers to improve the integrity of their future supportive care trials.

How Should Therapeutic Decisions about Expensive Drugs Be Made in Imperfect Environments?

“…The same percentages would apply if patients experienced intolerable toxicities within that sixmonth window and withdrew from using the drug. This approach is congruent with the dynamic value, patient-centered approach discussed earlier [8]. That is, patients would be at dramatically reduced risk of financial toxicity if the drugs were too medically toxic or failed to yield predicted gains in life expectancy.…”

“…They write: "The value of treatment may hang on modest reductions in progression, tolerable adverse effects, and out-of-pocket costs that are not ruinous. Each dimension can change quickly as treatment progresses" [8]. In other words, the NHB can change significantly from the patient's perspective-for better or worse, depending on the patient's values-as treatment proceeds.…”

An Automated Intervention Did Not Improve Adherence to Oral Oncolytic Agents While Managing Symptoms: Results From a Two-Arm Randomized Controlled Trial

“…In this study, actual pill counts were less of a problem than tracking refills and the combining of existing oral medications with newly received vials of medications. 31 Because we were most interested in establishing adherence and self-management behaviors after the initiation of treatment, this study did not follow patients' extended course of treatments, and thus we do not know their ultimate outcomes or have clinical evidence to define disease progression.…”

Interventions to support adherence to oral anticancer therapies: research challenges, lessons learned, and strategies to overcome them from Australia and Switzerland

“…Other barriers, such as staff's attitudes to and understanding of the intervention should also be considered in trial design [11,17].…”