Greenville, North Carolina 27587


Purpose:

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 summary:

Objective: To test the effectiveness of two telehealth adherence motivation strategies among cancer patients on oral chemotherapeutic agents who are at high-risk of non-adherence. The investigators are proposing a randomized multi-arm intervention study of 150 subjects with two intervention arms and a control arm (50 subjects per arm). The Information-Motivation-Behavioral Skills Model of Adherence and the results of specific aim 1 will guide this aim. Intervention Arm 1 will receive a Medication Event Monitoring System (MEMS) with feedback. Intervention Arm 2 will receive the MEMS plus a tailored nurse coaching component. Controls will receive standard-of-care from the Cancer Center. Specifically, the investigators want to test whether a tailored nurse coaching intervention component will significantly improve medication adherence at higher rates as compared to the MEMS alone. The MEMS is a medication bottle with a cap that is equipped with a microchip that registers the date and time of each cap opening (dosing history). Currently, there is no gold standard for measure of medication adherence but the MEMS device has been demonstrated to be a valid and objective method to assess medication adherence. The nurse coach intervention component will involve an individualized barriers/facilitators screening tool and regular contact with cancer patients via telephone calls across a six-month period. The investigators hypothesize that although both telehealth strategies will be effective at increasing medication adherence, Arm 2 will have a significantly greater effect on adherence. This hypothesis is supported by existing medication adherence literature that suggests a tailored intervention using multiple adherence strategies can potentially have a significant impact on increasing medication adherence.


Criteria:

Inclusion Criteria: 1. New cycle of OCAs 2. Ambulatory 3. Age 18 years or older 4. Able to consent for self 5. Able to read and speak English 6. Has a working cellphone or landline. Exclusion Criteria: 1. Life expectancy <3 months as determined by oncologist 2. Current participation in a similar study or in investigational drug trials where adverse effects have not been fully elucidated 3. Patients who are on simultaneous oral and IV chemotherapeutic regimens 4. Presence of significant psychiatric or cognitive impairments as determined by oncologists and study teams.


Study is Available At:


Original ID:

53517


NCT ID:

NCT02543723


Secondary ID:


Study Acronym:


Brief Title:

Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence


Official Title:

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.


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

East Carolina University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Essie Torres, PhD, MPH
Principal Investigator
East Carolina University
Primary Contact:Essie Torres, PhD, MPH
252-328-1818
torrese@ecu.edu
Backup Contact:Alice Richman, PhD, MPH
252-328-6431
richmana@ecu.edu

Study Dates

Start Date:June 1, 2017
Completion Date:August 2018
Completion Type:Anticipated
Primary Completion Date:August 2018
Primary Completion Type:Anticipated
Verification Date:July 2017
Last Changed Date:July 26, 2017
First Received Date:September 3, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Hospital Utilization
Time Frame:6 months
Safety Issues:False
Description:Looking at ER visits, hospitalizations and length of stay during the course of the study.
Outcome Type:Secondary Outcome
Measure:Health Literacy
Time Frame:6 months
Safety Issues:False
Description:Did the participant increase their health literacy via the nurse coach intervention provided
Outcome Type:Primary Outcome
Measure:Medication adherence
Time Frame:6 months
Safety Issues:False
Description:Within the 6-month follow-up period, was the participant adherent to their prescribed oral chemotherapeutic regimen.

Study Interventions

Intervention Type:Behavioral
Name:Nurse Coach Intervention
Description:Participants randomized to the intervention 2 group will receive the MEMS, plus a tailored nurse coach component. Participants will receive a 60-minute session conducted by the nurse coach. 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). MEMS feedback will be used to show Participants their own medication-taking beh
Arm Name:Nurse Coach Intervention
Intervention Type:Behavioral
Name:MEMs Intervention
Description:Participants will be advised to only open their pill bottles when they take their medications. Participants will also be given a MEMS diary to record unscheduled cap openings, such as those to refill the bottle, so that those unscheduled events unrelated to adherence can be removed from analysis. Participants will meet with the nurse coach during their regularly scheduled monthly oncology visits where the MEMS data will be collected. During this monthly meeting, participants in the intervention
Arm Name:MEMS Intervention

Study Arms

Study Arm Type:Active Comparator
Arm Name:Nurse Coach Intervention
Description:Before beginning their OCA regimen, participants in Arm 2 will be administered a barriers/facilitators screening tool that will help the nurse coach identify specific adherence strategies (i.e. cognitive education, knowledge skills, and affective support) tailored to the participant's needs. Once a tailored intervention plan is developed, participants will receive a 60-minute session conducted by the nurse coach. Participants will receive weekly phone calls from the nurse coach during the first
Study Arm Type:Active Comparator
Arm Name:MEMS Intervention
Description:Participants randomized to the lite group will receive a Medication Event Monitoring System (MEMS) device with feedback. Participants will be advised to only open their pill bottles when they take their medications. Participants will also be given a MEMS diary to record unscheduled cap openings, such as those to refill the bottle, so that those unscheduled events unrelated to adherence can be removed from analysis. The nurse coach will explain to the participant how to interpret the feedback rep

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:East Carolina University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Vidant Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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