Clinical trial NCT02043184: Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR
Official title: Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Breast Neoplasms
Colorectal Neoplasms
Melanoma
Leukemia
Keywords: Neoplasms
Medication Adherence
Administration, Oral
Symptom Assessment
Neurobehavioral Manifestations
Depression
Behavioral Symptoms
Utilization
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-01-23
Enrollment: 322
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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 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
* 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

Primary outcomes:
measure: Medication Adherence using pill count and self report
timeFrame: 8 weeks
Secondary outcomes:
measure: Medication Self-Efficacy using Horne Measure
timeFrame: 8 weeks
measure: Symptom Burden is determining the overall number of symptoms on the given symptom tool
timeFrame: 8 weeks
measure: Symptom Interference is the interference with daily activities
timeFrame: 8 weeks
measure: Depression using the full Clinical Screening for depression measure
timeFrame: 8 weeks
measure: Physical Function using the Physical Function Scale
timeFrame: 8 weeks
measure: Healthcare Utilization is the use of Emergency room and Hospital admissions
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Lansing
country: United States
facility: MSU Breslin Cancer Center
state: Michigan
city: Lansing
country: United States
facility: Sparrow Cancer Center
state: Michigan
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Michigan State University
name: Barbara Given, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan State University
name: Charles Given, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marshall VK, Given CW, Given BA, Lehto RH, Sikorskii A. Factors affecting medication beliefs among patients newly prescribed oral oncolytic agents. J Psychosoc Oncol. 2022;40(1):62-79. doi: 10.1080/07347332.2020.1855497. Epub 2020 Dec 11.
citation: Sikorskii A, Given CW, Given BA, Banik A, Krauss JC. Patient Engagement With an Automated Telephone Symptom Management Intervention: Predictors and Outcomes. Ann Behav Med. 2020 Jun 12;54(7):484-494. doi: 10.1093/abm/kaz067.
citation: Decker V, Sikorskii A, Given CW, Given BA, Vachon E, Krauss JC. Effects of depressive symptomatology on cancer-related symptoms during oral oncolytic treatment. Psychooncology. 2019 Jan;28(1):99-106. doi: 10.1002/pon.4916. Epub 2018 Oct 23.