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

Sponsor

Michigan State University (Other)

Overall Status

Completed

CT.gov ID

NCT02043184

Collaborator

National Cancer Institute (NCI) (NIH)

322

Enrollment

Locations

Arms

Duration (Months)

40.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

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).
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:

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.
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 or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms Breast Neoplasms Colorectal Neoplasms Melanoma Leukemia	Behavioral: Interactive Voice Response (IVR) Reminders	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

322 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Medication Adherence using pill count and self report [8 weeks]

Secondary Outcome Measures

Medication Self-Efficacy using Horne Measure [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 [8 weeks]
The Given Symptom assessment tool is used
Symptom Interference is the interference with daily activities [8 weeks]
This is an adaptation of the Cleeland Interference scale
Depression using the full Clinical Screening for depression measure [8 weeks]
we are using the CESD
Physical Function using the Physical Function Scale [8 weeks]
We use the PROMIS physical function measure
Healthcare Utilization is the use of Emergency room and Hospital admissions [8 weeks]
This captures the use during the 8 weeks and is Emergency room use and hospital admissions including length of stay.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06520
2	Northwestern University	Chicago	Illinois	United States	60611
3	Indiana University	Indianapolis	Indiana	United States	46202
4	University of Michigan	Ann Arbor	Michigan	United States	48109
5	MSU Breslin Cancer Center	Lansing	Michigan	United States	48910
6	Sparrow Cancer Center	Lansing	Michigan	United States	48912
7	Ohio State University	Columbus	Ohio	United States	43210
8	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15232