Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence

NCT02543723 | Completed Results

• 1 other identifier: 53517
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence

Keywords

medication adherence, telehealth strategies, nurse coaching

Outcome Measures

Primary Outcomes (1)

• Medication Adherence at Baseline and 6-month Follow-up Period

  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

Secondary Outcomes (1)

• Health Literacy at Baseline and 6-month Follow-up Period

  Baseline and at 6 months

Study Arms (2)

Nurse Coach Intervention

ACTIVE COMPARATOR

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.

Behavioral: Nurse Coach Intervention

Control

NO INTERVENTION

Patients received standard of care.

Interventions

Nurse Coach Intervention 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.

Nurse Coach Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

Vidant Medical Center

Greenville, North Carolina, 27587, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Essie Torres
• Organization: East Carolina University

torrese@ecu.edu

252-328-1818

Study Officials

• Essie Torres, PhD, MPH

  East Carolina University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were randomized into the control or intervention group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 7, 2015
• Study Start: November 15, 2015
• Primary Completion: March 30, 2020
• Study Completion: December 31, 2020
• Last Updated: July 22, 2021
• Results First Posted: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)