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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Michigan State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Given, Michigan State University
ClinicalTrials.gov Identifier:
NCT02043184
First received: January 20, 2014
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.

Condition Intervention
Prostatic Neoplasms
Breast Neoplasms
Colorectal Neoplasms
Melanoma
Leukemia
Behavioral: Interactive Voice Response (IVR) Reminders

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR

Resource links provided by NLM:


Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • Medication Adherence using pill count and self report [ Time Frame: 8, weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medication Self-Efficacy using Horne Measure [ Time Frame: 8, weeks ] [ Designated as safety issue: No ]
    this assess the ability to believe that they can adhere

  • Symptom Burden is determing the overall number of symptoms on the given symptom tool [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The Given Symptom assessment tool is used

  • Symptom Interference is the interference with daily activites [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    This is an adaptation of the Cleeland Interference scale

  • Depression using the full Clinical Screening for depression measure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    we are using the CESD

  • Physical Function using the Physical Function Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    We use the PROMIS physical function measure

  • Healthcare Utilization is the use of Emergency room and Hospital admissions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    This captures the use during the 8 weeks and is Emergency room use and hospital admissons including length of stay.


Estimated Enrollment: 274
Study Start Date: March 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 weeks, Daily IVR 4 weeks
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 weeks, Every other day IVR 4 weeks
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • Difficulty hearing on the telephone
  • Limited or no access to a touch tone phone
  • Cognitive deficits
  • Hospice care at enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043184

Contacts
Contact: Barbara Given, PhD 517-353-0306 Barb.Given@hc.msu.edu
Contact: Cindy Majeske, BA 517-353-8687 Cindy.Majeske@hc.msu.edu

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Ruth McCorkle, PhD    203-737-4137    Ruth.McCorkle@yale.edu   
Principal Investigator: Ruth McCorkle, PhD         
Sub-Investigator: Elizabeth Ercolano, RN, DNSc         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: John Krauss, MD    734-615-3969    jkrauss@med.umich.edu   
Principal Investigator: John Krauss, MD         
Sub-Investigator: Larry An, MD         
United States, Ohio
Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Niesha Griffith, MS    614-293-6835    Niesha.Griffith@osumc.edu   
Principal Investigator: Niesha Griffith, MS         
Sub-Investigator: Janine Overcash, PhD         
Sub-Investigator: Heather Brom         
Sub-Investigator: Elizabeth Kinkade Arthur         
Sponsors and Collaborators
Michigan State University
Investigators
Principal Investigator: Barbara Given, PhD Michigan State University
Principal Investigator: Charles Given, PhD Michigan State University
  More Information

No publications provided

Responsible Party: Barbara Given, University Distinguished Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT02043184     History of Changes
Other Study ID Numbers: 1R01CA162401-01A1, 1R01CA162401
Study First Received: January 20, 2014
Last Updated: January 21, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Michigan State University:
Neoplasms
Medication Adherence
Administration, Oral
Symptom Assessment
Neurobehavioral Manifestations
Depression
Behavioral Symptoms
Utilization

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Colorectal Neoplasms
Leukemia
Melanoma
Mouth Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Head and Neck Neoplasms
Mouth Diseases
Stomatognathic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male

ClinicalTrials.gov processed this record on July 29, 2014