Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Prostate Cancer, Colorectal Cancer, Skin Cancer, Blood Cancer, Leukemia |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 6/8/2017 |
| Start Date: | March 2013 |
| End Date: | July 2016 |
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.
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.
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.
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
We found this trial at
8
sites
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: John Krauss, MD
Phone: 734-615-3969
University of Michigan The University of Michigan was founded in 1817 as one of the...
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281 W. Lane Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Niesha Griffith, MS
Phone: 614-293-6835
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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