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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02043184
First Posted: January 23, 2014
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Given, Michigan State University
January 20, 2014
January 23, 2014
June 7, 2017
March 2013
July 2016   (Final data collection date for primary outcome measure)
Medication Adherence using pill count and self report [ Time Frame: 8 weeks ]
Medication Adherence using pill count and self report [ Time Frame: 8, weeks ]
Complete list of historical versions of study NCT02043184 on ClinicalTrials.gov Archive Site
  • Medication Self-Efficacy using Horne Measure [ Time Frame: 8 weeks ]
    this assesses the ability to believe that they can adhere
  • 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
  • Symptom Interference is the interference with daily activities [ Time Frame: 8 weeks ]
    This is an adaptation of the Cleeland Interference scale
  • Depression using the full Clinical Screening for depression measure [ Time Frame: 8 weeks ]
    we are using the CESD
  • Physical Function using the Physical Function Scale [ Time Frame: 8 weeks ]
    We use the PROMIS physical function measure
  • 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.
  • Medication Self-Efficacy using Horne Measure [ Time Frame: 8, weeks ]
    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 ]
    The Given Symptom assessment tool is used
  • Symptom Interference is the interference with daily activites [ Time Frame: 8 weeks ]
    This is an adaptation of the Cleeland Interference scale
  • Depression using the full Clinical Screening for depression measure [ Time Frame: 8 weeks ]
    we are using the CESD
  • Physical Function using the Physical Function Scale [ Time Frame: 8 weeks ]
    We use the PROMIS physical function measure
  • 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 admissons including length of stay.
Not Provided
Not Provided
 
Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR
Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
  • Prostatic Neoplasms
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Melanoma
  • Leukemia
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.
  • Active Comparator: Standard Care 12 weeks
    Standard care. Standard supportive care and Toolkit given at 12 weeks.
    Intervention: Behavioral: Interactive Voice Response (IVR) Reminders
  • Experimental: Standard Care 8 wks, Daily IVR 4 wks
    Interactive Voice Response (IVR) Reminders Daily delivery for the last 4 weeks of the study.
    Intervention: Behavioral: Interactive Voice Response (IVR) Reminders
  • Experimental: Daily IVR 8 weeks
    Interactive Voice Response (IVR) Reminders daily for the first 8 weeks of the study.
    Intervention: Behavioral: Interactive Voice Response (IVR) Reminders
  • 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.
    Intervention: Behavioral: Interactive Voice Response (IVR) Reminders
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
322
July 2016
July 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02043184
1R01CA162401-01A1( U.S. NIH Grant/Contract )
1R01CA162401 ( U.S. NIH Grant/Contract )
No
Not Provided
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available.
Barbara Given, Michigan State University
Michigan State University
National Cancer Institute (NCI)
Principal Investigator: Barbara Given, PhD Michigan State University
Principal Investigator: Charles Given, PhD Michigan State University
Michigan State University
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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