- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02543723
Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to improve cancer patient's adherence to their oral chemotherapy agents. We want to test whether a tailored nurse coaching intervention will significantly improve medication adherence as compared to a control group (standard-of-care). With strong support from our collaborators at the Vidant Cancer Care - Eddie and Jo Allison Smith Tower at Vidant Medical Center (VCC), study participants included cancer patients that were within their first two cycles of a new oral chemotherapy regimen at Vidant Medical Center/Leo W. Jenkins Cancer Center, which serves individuals throughout the 29 counties in rural eastern North Carolina (ENC).
Study Objectives:
Objective 1: To assess the barriers to, and facilitators of, adherence to oral chemotherapeutic agents among cancer patients who are at high-risk of non-adherence. Using the three-stage process of elicitation, intervention, and evaluation, we assessed factors that influenced non-adherence among this population. This formative qualitative assessment was accomplished by conducting interviews with English speaking cancer patients (N=25) and through key informant interviews/focus groups with cancer care providers (N=10). Objective 1 served as a baseline assessment to identify the unique factors that contribute to non-adherence and directly informed the development of tailored medication adherence strategies outlined in objective 2.
Objective 2. To test the effectiveness a telehealth adherence motivation strategy among cancer patients on oral chemotherapeutic agents who are at high-risk of non-adherence.
We conducted a randomized control trial study of 150 subjects where subjects were randomly assigned to control or intervention arm. The Information-Motivation-Behavioral Skills Model of Adherence and the results of objective 1 guided this aim. Controls received the standard-of-care. The intervention arm received the standard-of-care and the nurse coach intervention. Specifically, we assessed whether a tailored nurse coaching intervention component will significantly improve medication adherence at higher rates as compared to the control group. The nurse coach intervention component involved individualized barriers/facilitators screening tool, educational tools, and regular contact with cancer patients via telephone calls across a six-month period. We hypothesize that the nurse-coach intervention would be effective at increasing medication 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Greenville, North Carolina, United States, 27587
- Vidant Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Nurse Coach Intervention
The nurse coach conducted an initial assessment with the participant and identified specific adherence strategies tailored to the participant's needs.
The educational strategies include information about the patient's cancer treatment and expected outcomes; clear instructions about medication dosing schedule; what to do if a dose is missed or delayed; medication side effects and/or potential drug interactions; and review of cancer health literacy infographics.
The behavioral skills and affective support strategies include coping strategies for side effects, skills for fitting medication regimen into daily routine, identifying a support network, communication skills for interacting with providers, and facilitating a positive perception for effective self-management experience.
Patients received 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.
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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.
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No Intervention: Control
Patients received standard of care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication Adherence at Baseline and 6-month Follow-up Period
Time Frame: Baseline and at 6 months
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The participant's cancer medication adherence was taken at baseline and within a 6-month follow-up period. We measured the participant's self-efficacy with medication adherence increase with their OCAs using the SEAMS scale. SEAMS Scale: 21 items scale, ranges from 21-63, higher scores indicate higher level of self-efficacy for medication adherence. |
Baseline and at 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Literacy at Baseline and 6-month Follow-up Period
Time Frame: Baseline and at 6 months
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We measured the participant's cancer health literacy at baseline and at 6 months via the CHLT-30. The CHLT-30 measures cancer health literacy along a continuum with 0-30 representing the number of correct answers provided to the items. Continuous scores provided by the CHLT-30 do not allow to determine who has limited health literacy or put people in a category, with higher scores indicating a higher degree of cancer health literacy. |
Baseline and at 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 53517
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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