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NCT02337296 · ClinicalTrials.gov registry record · NA
An Intervention to Promote Oral Agent Adherence and Symptom Management: ADHERE
A NA study, sponsored by Michigan State University.
- Completed
- Registry status
- NA
- Development phase
- 59
- Enrollment target
NCT02337296 is a NA study that has completed, run by Michigan State University. The registered enrollment target is 59 participants.
The verdict
NCT02337296, a NA study, has completed, sponsored by Michigan State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 59 participants
- Enrollment target
Study Summary
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.
Interventions
- BEHAVIORAL ADHERE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2014-01 |
| Est. Completion | 2016-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02337296
The ClinicalTrials.gov registry entry for NCT02337296 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michigan State University, which has 120 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ADHERE is the first listed.
NCT02337296 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02337296 about?
NCT02337296 is a clinical study titled "An Intervention to Promote Oral Agent Adherence and Symptom Management: ADHERE". 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 prescrib...
What is the current status of trial NCT02337296?
This trial is currently completed. It is a NA study. The enrollment target is 59 participants. The study started on 2014-01. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02337296?
The interventions under investigation include: ADHERE (BEHAVIORAL).
Who is sponsoring clinical trial NCT02337296?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
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