Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR
2 other identifiers
interventional
322
1 country
8
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.
- 3.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.
- 4.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 20, 2014
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJune 7, 2017
June 1, 2017
3.3 years
January 20, 2014
June 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication Adherence using pill count and self report
8 weeks
Secondary Outcomes (6)
Medication Self-Efficacy using Horne Measure
8 weeks
Symptom Burden is determining the overall number of symptoms on the given symptom tool
8 weeks
Symptom Interference is the interference with daily activities
8 weeks
Depression using the full Clinical Screening for depression measure
8 weeks
Physical Function using the Physical Function Scale
8 weeks
- +1 more secondary outcomes
Study Arms (4)
Standard Care 12 weeks
ACTIVE COMPARATORStandard care. Standard supportive care and Toolkit given at 12 weeks.
Standard Care 8 wks, Daily IVR 4 wks
EXPERIMENTALInteractive Voice Response (IVR) Reminders Daily delivery for the last 4 weeks of the study.
Daily IVR 8 weeks
EXPERIMENTALInteractive Voice Response (IVR) Reminders daily for the first 8 weeks of the study.
Daily IVR 4 wk, Every other day IVR 4 wk
EXPERIMENTALInteractive Voice Response (IVR) Reminders daily for the first 4 weeks of the study and every other day for weeks 4-8.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michigan State Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (8)
Yale University
New Haven, Connecticut, 06520, United States
Northwestern University
Chicago, Illinois, 60611, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
MSU Breslin Cancer Center
Lansing, Michigan, 48910, United States
Sparrow Cancer Center
Lansing, Michigan, 48912, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
Related Publications (3)
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.
PMID: 33305993DERIVEDSikorskii 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.
PMID: 31925414DERIVEDDecker 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.
PMID: 30311987DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Given, PhD
Michigan State University
- PRINCIPAL INVESTIGATOR
Charles Given, PhD
Michigan State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University Distinguished Professor
Study Record Dates
First Submitted
January 20, 2014
First Posted
January 23, 2014
Study Start
March 1, 2013
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
June 7, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be made available.