Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR

Completed · Not applicable

Conditions studied: Prostatic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Melanoma, Leukemia

In brief

Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR The goals of this study are to improve adherence to oral chemotherapeutic medications and self-management of symptoms among cancer patients. More than 40 oral agents currently are on the market with projections that in three years 30% 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. This longitudinal randomized trial tests and compares 'two strategies' for improving patient adherence to their oral cancer medication prescriptions to standard care. Both strategies incorporate symptom management support using an interactive voice response system (IVR) for symptom assessment and a printed evidence-based Medication Management and Symptom Management Toolkit (Toolkit) with helpful strategies and information for symptom management. We will collaborate with NCI Comprehensive Cancer Centers to recruit patients into this study. Recruiters will identify patients as they are prescribed oral cancer medications, present the study to the patient, and ask them to consent to be part of the study. Study Aims Following are the Aims of the study. 1. Cancer patients assigned to the intervention will have greater adherence to their prescribed regimen: a) at week 4 (immediate effect), and b) at weeks 8 and 12 (sustained effect). 2. When compared with patients receiving weekly assessments only, patients receiving weekly assessments plus daily adherence reminders and printed symptom management strategies for 4 weeks will report: lower symptom severity during weeks 2-4 that will be sustained at weeks 5-8, and at 12 weeks. Two exploratory aims are assessed: 1. To test how patient characteristics (age, sex, depression), dose variation, symptom severity, and concurrent infusion therapy moderate the impact of the novel intervention on adherence at 4, 8, and 12 weeks. 2. To test the impact of the novel intervention on dose alterations, emergency department visits and hospital admissions over the 12 weeks in order to support the translation of this system into oncology practices.

Key facts

Study ID

NCT02043184

Run by

Michigan State University

People needed

322

Starts

2013-03-01

Expected to finish

2016-07-01

Last updated by the study team

2017-06-07

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 21 years of age or older
• Newly prescribed one of the designated oral cancer medications for treatment of cancer
• ECOG score of 0,1,or 2 OR Karnofsky score of 50 or higher
• Patient of one of the participating National Cancer Institute comprehensive cancer centers
• Able to speak, read and understand English
• Able and willing to receive phone calls

You may not qualify if…

• Difficulty hearing on the telephone
• Limited or no access to a touch tone phone
• Cognitive deficits
• Hospice care at enrollment
• Those prescribed a hormonal therapy for cancer

Where it is running

• Yale University — New Haven, Connecticut, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• MSU Breslin Cancer Center — Lansing, Michigan, United States
• Sparrow Cancer Center — Lansing, Michigan, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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