Novel Tool to Monitor Adherence to Oral Oncolytics: A Pilot Study

PURPOSE Nonadherence is a significant issue in cancer care, especially as more oral therapies become available. Measuring and optimizing adherence to such therapies is challenging. In this study, we tested a novel technology that records real-time medication-taking behavior from a smart prescription bottle and can communicate with patients via text message to intervene in cases of nonadherence. METHODS We conducted a 28-patient pilot study to assess the feasibility of this technology in measuring and improving adherence in patients taking capecitabine, an oral chemotherapy agent with a complex, cyclical regimen. The study had a preintervention stage, during which patients were monitored, and an intervention stage, during which the text messaging intervention was enabled. RESULTS During preintervention, patients had an average self-adherence of 89%, and during post intervention, they had an average adherence of 90%. We defined three categories of patients by change in adherence: category 1 (> 8%), category 2 (−8% to 8%), and category 3 (< −8%). Patients in category 1 tended to live in regions with lower average household income (mean = $58,937 in US dollars [USD]) than those in category 2 (mean = $77,482 USD) and category 3 (mean = $90,972 USD). Of poststudy survey respondents, most indicated that they would want to continue using this technology and that they would recommend it to others. CONCLUSION This novel technology is able to monitor, measure, and intervene for patients taking capecitabine in real time. Adherence overall was high, and some patients appeared to benefit more from text-message interventions. Future work should focus on patients deemed high risk for nonadherence.

A novel tool to monitor adherence to oral oncolytics: A pilot study.

286 Background: Non-adherence is an important issue in cancer care as more oral cytotoxic and targeted agents become available. Although oral therapies may be more convenient for patients, measuring and optimizing adherence is challenging. The Nomi system records real-time medication taking behavior from a "smart" prescription bottle and displays the data on a web-based interface. Nomi can also communicate with patients via text message to intervene in cases of non-adherence. We report the results of a 28-patient pilot study aiming to assess Nomi’s ability to assist patients taking capecitabine, an oral chemotherapy agent with a complex, cyclical regimen. Methods: Eligible patients were prescribed capecitabine for breast, colorectal, pancreatic, or biliary cancer. The study had a pre-intervention stage, during which patients were monitored, and an intervention stage, in which the text messaging feature was enabled. Adherence was defined as the number of correct doses (both timing and quantity) over the total number of prescribed doses. Conversions were events in which patients took a dose after receiving a text intervention (from Nomi). We defined three categories of patients by percent change in adherence: category 1 ( > 8%), category 2 (-8% to 8%), and category 3 ( < -8%). Results: We collected data from 28 patients (24 pre/post and 4 pre-only). On average, patients were 84% adherent (N = 28; SD = 11%). During pre-intervention, patients had a self-adherence of 89% (SD = 12%), and afterwards, they had an average adherence of 90% (SD = 6%). Most of the patients in category 1 demonstrated a substantial conversion rate ( > 35%). Patients in category 1 tended to live in regions with lower average household income (Mean = $58,937) than those in category 2 (Mean = $77,482) and category 3 (Mean = $90,972). Of survey respondents, 56% indicated that they would want to continue using Nomi, while 67% indicated that they would recommend it to others. Conclusions: This innovative technology is able to monitor, measure and intervene for patients taking capecitabine in real-time. Adherence overall was high, and some patients appeared to benefit more from text message interventions. Future work should focus on patients deemed high risk for non-adherence.

Ornithine decarboxylase and polyamines in liver and kidneys of rats on cyclical regimen of protein-free and protein-containing diets. Relationship to deoxyribonucleic acid synthesis in liver

1. The activity of ornithine decarboxylase in the liver and kidneys of rats maintained on a cyclical regimen of protein-free and protein-containing diets was investigated. There was a daily activation of the enzyme in response to the feeding of protein after 3 days feeding of protein-free diet. 2. The activation of ornithine decarboxylase in the liver and kidneys of rats re-fed on protein was demonstrable throughout 16 cycles of alternating 3-day periods of protein-free and protein-containing diets. The magnitude of the activation in the kidneys diminished from 20-fold stimulation in the first cycle to 5-fold stimulation (compared with animals fed with protein-free diet) in the later cycles of protein re-feeding. The activation of the enzyme in liver was decreased from 20-fold stimulation in the first cycle to approx. 10-fold stimulation in later cycles. 3. The concentration of spermidine was increased by approx. 50% in the liver of animals during cycling from protein-free to protein-containing diets. Spermine was unchanged, and putrescine was maintained at a low concentration approx. one-fifth to one-tenth that of spermidine after protein re-feeding. 4. The incorporation of [3H]thymidine into liver DNA was increased 10-fold in animals re-fed with protein compared with animals receiving protein-free diets. 5. The activation of ornithine decarboxylase by re-feeding of protein was inhibited 90% by the injection of propane-1,3-diamine during re-feeding. The stimulation of DNA synthesis was inhibited 60% by multiple injections of propane-1,3-diamine during the re-feeding of protein.