The goals of this application are to improve adherence to oral chemotherapeutic medications and self- management of symptoms among cancer patients. Forty oral agents currently are on the market with projections that in 3 years 25% of the cancer treatment agents will be delivered in oral form. As a result, patients must assume responsibility for taking medications and self-management of associated side effects. To address these issues we collaborate with four NCI Comprehensive Cancer Centers who will identify patients as they are prescribed oral agents, present the study, and those accepting will be randomized to one of two arms. All patients in both arms will receive 8 weekly assessments of adherence and symptom severity. In addition, those in the experimental arm will receive daily reminder calls for the initial 4 weeks of their scripts tailored to their dose. For symptoms reported above threshold they will be referred to a symptom management guide (SMG) to assist with self-management. A unique feature is that assessments, reminders, and symptom management strategies will be delivered by an Interactive Voice Response system (IVR). This system has been tested in a previous trial and in a pilot study of adherence;it received high satisfaction ratings from patients. The following outcomes are tested: at 4 weeks the experimental arm will have higher levels of self-reported adherence, and symptom management and these differences will be sustained at 8 and at 12 weeks. In addition, the experimental arm will report lower rates of both over and under adherence at 4, 8, and 12 weeks. Exploratory aims assess the moderating effects patient and treatment variables on adherence and symptom management. A final exploratory aim evaluates an important but heretofore untested question: what is the relationship between adherence and patients'symptom management? This research is guided by past trials and a large pilot study of adherence to oral agents and symptom management. Patient reported adherence is validated against pill counts, and scripts from patients'records. Daily reminders include a question to determine if dose was changed. If this occurs, staff in each site monitor visits and calls so that reminders are stopped or adjusted to dose immediately upon any alteration. All strategies for managing symptoms are evidence based and tested through earlier work of this team. Symptoms reaching urgent levels are communicated to staff at each site. This trial is coordinated through a project website. The impact of this trial is that it tests a short targeted reminder system to model adherence at the onset of treatment. It is accompanied by patient centered strategies for symptom management. This system is embedded into oncology centers;it can potentially transform oral chemotherapy treatment while assuring patient safety.

Public Health Relevance

Oral medications are transforming treatments for cancer. Thus, adherence with these medications is an abiding concern. This research tests strategies for assisting patients to adhere to their oral agents and to manage the symptoms that arise from their disease and treatment.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project (R01)
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Study Section
Nursing and Related Clinical Sciences Study Section (NRCS)
Program Officer
O'Mara, Ann M
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Michigan State University
Schools of Nursing
East Lansing
United States
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Given, Charles W; Given, Barbara A; Sikorskii, Alla et al. (2018) Challenges to the design and testing supportive interventions for cancer patients treated with oral oncolytic agents. Support Care Cancer 26:3975-3977
Leonenko, N N; Papi?, I; Sikorskii, A et al. (2017) Heavy-tailed fractional Pearson diffusions. Stoch Process Their Appl 127:3512-3535
Given, Barbara A; Given, Charles W (2017) To Improve Cancer Treatment, We Need to Have Patients and Care Teams Connected! Cancer Nurs 40:255-256
Given, Charles W; Given, Barbara A (2016) Care of the Elderly Patient on Oral Oncolytics for Advanced Disease. Curr Geriatr Rep 5:233-239
Given, Barbara A; Given, Charles W; Vachon, Eric et al. (2016) Do We Have a Clue: The Treatment Burden for the Patient With Cancer? Cancer Nurs 39:423-4
Given, Charles W; Given, Barbara A; Bradley, Cathy J et al. (2016) Dynamic Assessment of Value During High-Cost Cancer Treatment: A Response to American Society of Clinical Oncology and European Society of Medical Oncology. J Oncol Pract 12:1215-1218
Given, Barbara A (2016) Oral Oncolytic Agents--A Need for Research to Enhance Patient Centeredness? Cancer Nurs 39:84-5