Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR

June 6, 2017 updated by: Barbara Given, Michigan State University

Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR The goals of this study are to improve adherence to oral chemotherapeutic medications and self-management of symptoms among cancer patients. More than 40 oral agents currently are on the market with projections that in three years 30% of the cancer treatment agents will be delivered in oral form. As a result, patients must assume responsibility for taking medications and self-management of associated side effects.

This longitudinal randomized trial tests and compares 'two strategies' for improving patient adherence to their oral cancer medication prescriptions to standard care. Both strategies incorporate symptom management support using an interactive voice response system (IVR) for symptom assessment and a printed evidence-based Medication Management and Symptom Management Toolkit (Toolkit) with helpful strategies and information for symptom management.

We will collaborate with NCI Comprehensive Cancer Centers to recruit patients into this study. Recruiters will identify patients as they are prescribed oral cancer medications, present the study to the patient, and ask them to consent to be part of the study.

Study Aims Following are the Aims of the study.

  1. Cancer patients assigned to the intervention will have greater adherence to their prescribed regimen: a) at week 4 (immediate effect), and b) at weeks 8 and 12 (sustained effect).
  2. When compared with patients receiving weekly assessments only, patients receiving weekly assessments plus daily adherence reminders and printed symptom management strategies for 4 weeks will report: lower symptom severity during weeks 2-4 that will be sustained at weeks 5-8, and at 12 weeks.

Two exploratory aims are assessed:

  1. To test how patient characteristics (age, sex, depression), dose variation, symptom severity, and concurrent infusion therapy moderate the impact of the novel intervention on adherence at 4, 8, and 12 weeks.
  2. To test the impact of the novel intervention on dose alterations, emergency department visits and hospital admissions over the 12 weeks in order to support the translation of this system into oncology practices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Design and Methods A unique feature of this study is that assessments, reminders, and symptom management strategies will be delivered by an Interactive Voice Response system (IVR). This system has been tested in a previous trial and in a pilot study of medication adherence; it received high satisfaction ratings from patients.

All patients will complete intake (baseline), 4 week, 8 week, and 12 week interviews for symptom severity, depression, beliefs about oral agents, self-efficacy, and pill count. Following the intake interview a computerized procedure will randomize patients to one of two groups: experimental and control. Patients in both arms will receive 12 weekly assessments of adherence to their oral cancer medications and symptom severity delivered by the IVR.

In addition, patients in the experimental group will receive daily reminder calls for 4 weeks delivered by the IVR. At the end of week 4 patients will be offered the option to reduce calls to every other day, or continue with daily reminders for weeks 5-8. Reminder calls will be tailored to the cycle of each medication. Daily reminder calls include a question to determine if medication changes have occurred. If this occurs, reminder calls are stopped and/or adjusted to the revised prescription. Patients in the experimental group will be mailed a Toolkit. Patients who report symptoms above designated thresholds during a weekly assessment call will be referred to the Toolkit to assist with self-management.

The control group will not receive IVR reminder calls during the first 8 weeks. Control group patients, who report difficulty taking their cancer medications as prescribed, will be randomized following the 8 week interview to either receive 4 weeks of daily IVR reminder calls during weeks 9-12, or to continue in the control group. Patients randomized to receive daily IVR reminder calls will receive a Toolkit following randomization (and if during their weekly assessment calls they report symptoms above designated thresholds they will be referred to the Toolkit to assist with self-management). Patients randomized to continue in the control group will receive a Toolkit upon completion of the 12 week interview.

Medical records will be audited for oral cancer medication changes during the study period as well as adverse toxic events noted, and scripts written.

Implications & Impact This research will identify and explore the factors (symptom severity, medication complexity, patient characteristics) affecting adherence to oral cancer medications and how symptom management might improve levels of adherence. This will allow patients to engage in their care and potentially transform the safety and quality of cancer care for patients on oral cancer medications.

Study Type

Interventional

Enrollment (Actual)

322

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Cancer Center
      • Lansing, Michigan, United States, 48910
        • MSU Breslin Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 21 years of age or older
  • Newly prescribed one of the designated oral cancer medications for treatment of cancer
  • ECOG score of 0,1,or 2 OR Karnofsky score of 50 or higher
  • Patient of one of the participating National Cancer Institute comprehensive cancer centers
  • Able to speak, read and understand English
  • Able and willing to receive phone calls

Exclusion Criteria:

  • Difficulty hearing on the telephone
  • Limited or no access to a touch tone phone
  • Cognitive deficits
  • Hospice care at enrollment
  • Those prescribed a hormonal therapy for cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Care 12 weeks
Standard care. Standard supportive care and Toolkit given at 12 weeks.
Behavioral: Interactive Voice Response (IVR) Reminders
Reminders tailored to the oral cancer medication(s) the patients are receiving delivered by interactive voice response system with referral to a self-management guide when symptoms exceed thresholds.
Experimental: Standard Care 8 wks, Daily IVR 4 wks
Interactive Voice Response (IVR) Reminders Daily delivery for the last 4 weeks of the study.
Behavioral: Interactive Voice Response (IVR) Reminders
Reminders tailored to the oral cancer medication(s) the patients are receiving delivered by interactive voice response system with referral to a self-management guide when symptoms exceed thresholds.
Experimental: Daily IVR 8 weeks
Interactive Voice Response (IVR) Reminders daily for the first 8 weeks of the study.
Behavioral: Interactive Voice Response (IVR) Reminders
Reminders tailored to the oral cancer medication(s) the patients are receiving delivered by interactive voice response system with referral to a self-management guide when symptoms exceed thresholds.
Experimental: Daily IVR 4 wk, Every other day IVR 4 wk
Interactive Voice Response (IVR) Reminders daily for the first 4 weeks of the study and every other day for weeks 4-8.
Behavioral: Interactive Voice Response (IVR) Reminders
Reminders tailored to the oral cancer medication(s) the patients are receiving delivered by interactive voice response system with referral to a self-management guide when symptoms exceed thresholds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medication Adherence using pill count and self report
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Self-Efficacy using Horne Measure
Time Frame: 8 weeks
this assesses the ability to believe that they can adhere
8 weeks
Symptom Burden is determining the overall number of symptoms on the given symptom tool
Time Frame: 8 weeks
The Given Symptom assessment tool is used
8 weeks
Symptom Interference is the interference with daily activities
Time Frame: 8 weeks
This is an adaptation of the Cleeland Interference scale
8 weeks
Depression using the full Clinical Screening for depression measure
Time Frame: 8 weeks
we are using the CESD
8 weeks
Physical Function using the Physical Function Scale
Time Frame: 8 weeks
We use the PROMIS physical function measure
8 weeks
Healthcare Utilization is the use of Emergency room and Hospital admissions
Time Frame: 8 weeks
This captures the use during the 8 weeks and is Emergency room use and hospital admissions including length of stay.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Barbara Given, PhD, Michigan State University
  • Principal Investigator: Charles Given, PhD, Michigan State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01CA162401-01A1 (U.S. NIH Grant/Contract)
  • 1R01CA162401 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made available.

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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