N/A
N=128
Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence
Medication Adherence
Bottom Line
View on ClinicalTrials.gov: NCT02543723 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Medication Adherence at Baseline and 6-month Follow-up Period — 59.4; 55.95 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nurse Coach Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- East Carolina University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication Adherence at Baseline and 6-month Follow-up Period |
59.4; 55.95 | — |
| SECONDARY Health Literacy at Baseline and 6-month Follow-up Period |
22.95; 23.32 | — |
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.
Eligibility Criteria
Inclusion Criteria
- New cycle or withing the first 3 cycles of OCAs
- Ambulatory
- Age 18 years or older
- Able to consent for self
- Able to read and speak English
- Has a working cellphone or landline.
Exclusion Criteria
- Life expectancy <3 months as determined by oncologist
- Current participation in a similar study or in investigational drug trials where adverse effects have not been fully elucidated
- Presence of significant psychiatric or cognitive impairments as determined by oncologists and study teams.
Data sourced from ClinicalTrials.gov (NCT02543723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.