An Intervention to Promote Oral Agent Adherence and Symptom Management: ADHERE
Completed · Not applicable
Conditions studied: Cancer
In brief
This study includes a novel intervention entitled "ADHERE," which includes one semi-structured 30-minute face-to-face session and three 10-minute weekly phone sessions over 4 weeks, administered by an advanced practice nurse (APRN) to promote management of symptoms and adherence in patients prescribed oral anti-cancer agents. Innovations in cancer treatment are changing the treatment delivery landscape. It is projected that by 2015, 25% of treatment will be delivered in pill form. This shift in the treatment paradigm places greater responsibility on patients. However, patients with cancer are known to miss as much as one-third of the prescribed doses of oral agents required for treatment of their disease. Barriers to oral agent adherence include symptom severity, low self-efficacy, depressive symptoms, lack of motivation, or beliefs that the medicine will not help, age, and regimen complexity. The therapeutic outcome for those taking oral agents depends heavily on the ability of patients to adhere to the prescribed regimen. Thus, a critical need exists to test interventions that promote adherence and symptom management in patients taking oral agents. ADHERE provides systematic patient education (PE) with the investigators evidence-based Medication Management and Symptom Management Toolkit (Toolkit). This is combined with brief cognitive behavioral therapy (CBT) to focus thoughts and beliefs to influence action; and motivational interviewing (MI) to elicit reasons from patients to take action. The National Cancer Institute (NCI), American Society of Clinical Oncology (ASCO), and Oncology Nursing Society (ONS) have made adherence to oral agents a priority. Thus, the investigators are testing ADHERE's impact on symptom severity and adherence to the oral agent regimen and determining the acceptability and feasibility of the intervention among patients with cancer.
Key facts
- Study ID
- NCT02337296
- Run by
- Michigan State University
- People needed
- 59
- Starts
- 2014-01-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2016-03-16
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with cancer
- Newly prescribed (within 60-days) an oral anti-cancer agent
- Have a phone and be willing and able to receive phone calls
- Able to read, speak, and understand English
- Cognitively intact and able to self-manage and follow direction, as evaluated by the Recruiter
You may not qualify if…
- Unable to accept phone calls
Where it is running
- Allegiance Health — Jackson, Michigan, United States
- Huron Medical Center — Port Huron, Michigan, United States
Full record on ClinicalTrials.gov
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