Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence

NCT ID: NCT02543723

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-15
• Study Completion Date: 2020-12-31

Brief 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.

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.

Conditions

Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Nurse Coach Intervention

Intervention Type: BEHAVIORAL

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.

Control

Patients received standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nurse Coach Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. New cycle or withing the first 3 cycles 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. Presence of significant psychiatric or cognitive impairments as determined by oncologists and study teams.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

East Carolina University

OTHER

Sponsor Role: lead

Responsible Party

Essie Torres

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Essie Torres, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

East Carolina University

Locations

Vidant Medical Center

Greenville, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

53517

Identifier Type: -

Identifier Source: org_study_id