At a glance
ClinicalIndex Comparison Record- ✓New cycle or within first 3 cycles of oral chemotherapeutic agents (OCAs)
- ✓Ambulatory (able to travel for care)
- ✓Age 18 years or older
- ✓Able to consent independently
- ✕Life expectancy less than 3 months as determined by oncologist
- ✕Current participation in similar study or investigational drug trials with unevaluated adverse effects
- ✕Significant psychiatric or cognitive impairments that would prevent study participation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Longitudinal Intervention Study to Assess the Efficacy and Feasibility of Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence and Health Literacy Among Cancer Patients.
In Brief
A clinical study evaluating Nurse Coach Intervention for Medication Adherence. Completed, enrolled 128 participants across 1 site.
Detailed Summary
Oral chemotherapeutic agents (OCAs) are increasingly being used as an alternative to traditional intravenous chemotherapy, and factors promoting this trend include increased survival times requiring long-term therapy, acceptability among patients, convenience, and cost savings due to reduced hospital time. Although OCAs are commonly preferred by patients, adherence to these medications vary. Suboptimal medication adherence leads to loss of treatment efficacy, increased toxicity, and increased health care costs. Thus, it is critical to develop and test interventions that effectively improve adherence to OCAs. Although the medication adherence literature has been criticized for methodological issues, some components of interventions have had promising results on adherence such as electronic monitored adherence feedback, cognitive-education, nurse-based interventions, and technology-based or telehealth strategies. The investigators propose to unify components of these effective approaches in a novel way to assess the efficacy and feasibility of two telehealth-based strategies (electronic medication-event monitoring with feedback and tailored nurse coaching which includes cognitive-education) in an effort increase OCA adherence among cancer patients who are at high-risk for non-adherence in rural eastern North Carolina.
Study Details
Timeline
Interventions
Participants randomized to the intervention 2 group a tailored nurse coach component. Participants will receive an initial session conducted by the nurse coach, via phone or in-person. Participants will receive weekly phone calls from the nurse coach during the first month of the intervention, and then bi-monthly follow-up calls for the remainder of treatment or 6-month follow-up period (whichever occurs first). The nurse coach will modify the intervention plan to address identified barriers to adherence at this time.