Prostatic NeoplasmsNCT02043184
Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR
A study testing Interactive Voice Response (IVR) Reminders in people with Prostatic Neoplasms and Breast Neoplasms, run by Michigan State University at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Prostatic Neoplasms, Breast Neoplasms, Colorectal Neoplasms
- What is being tested?
- Interactive Voice Response (IVR) Reminders
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan
Ann Arbor, Michigan, 48109
Northwestern University
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43210
Indiana University
Indianapolis, Indiana, 46202
MSU Breslin Cancer Center
Lansing, Michigan, 48910
Sparrow Cancer Center
Lansing, Michigan, 48912
Yale University
New Haven, Connecticut, 06520
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Prostatic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Melanoma, Leukemia
- Being tested
- Interactive Voice Response (IVR) Reminders
- Keywords
- Neoplasms, Medication Adherence, Administration, Oral, Symptom Assessment, Neurobehavioral Manifestations, Depression, Behavioral Symptoms, Utilization
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Melanoma, Leukemia, Neoplasms, Medication Adherence, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Voice Response (IVR) RemindersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care 12 weeks | Active comparator | Standard care. Standard supportive care and Toolkit given at 12 weeks. Receives: Behavioral: Interactive Voice Response (IVR) Reminders |
| Standard Care 8 wks, Daily IVR 4 wks | Experimental | Interactive Voice Response (IVR) Reminders Daily delivery for the last 4 weeks of the study. Receives: Behavioral: Interactive Voice Response (IVR) Reminders |
| Daily IVR 8 weeks | Experimental | Interactive Voice Response (IVR) Reminders daily for the first 8 weeks of the study. Receives: Behavioral: Interactive Voice Response (IVR) Reminders |
| Daily IVR 4 wk, Every other day IVR 4 wk | Experimental | Interactive Voice Response (IVR) Reminders daily for the first 4 weeks of the study and every other day for weeks 4-8. Receives: Behavioral: Interactive Voice Response (IVR) Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence using pill count and self report
Measured: 8 weeks
Secondary outcomes (6)
Medication Self-Efficacy using Horne Measure
this assesses the ability to believe that they can adhere
Measured: 8 weeks
Symptom Burden is determining the overall number of symptoms on the given symptom tool
The Given Symptom assessment tool is used
Measured: 8 weeks
Symptom Interference is the interference with daily activities
This is an adaptation of the Cleeland Interference scale
Measured: 8 weeks
Depression using the full Clinical Screening for depression measure
we are using the CESD
Measured: 8 weeks
Physical Function using the Physical Function Scale
We use the PROMIS physical function measure
Measured: 8 weeks
Healthcare Utilization is the use of Emergency room and Hospital admissions
This captures the use during the 8 weeks and is Emergency room use and hospital admissions including length of stay.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startMar 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Barbara Given, Michigan State University
- Investigators
- Barbara Given, PhD, Principal investigator, Michigan State UniversityCharles Given, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043184
- Sponsor's protocol ID
- 1R01CA162401-01A1
- Other IDs
- 1R01CA162401
- Status last verified
- Jun 2017
- First submitted
- 20 Jan 2014
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be made available.
Publications
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.
PubMed 33305993Sikorskii 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.
PubMed 31925414Decker 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.
PubMed 30311987
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR
- ClinicalTrials.gov ID
- NCT02043184
- Acronym / sponsor ID
- 1R01CA162401-01A1
- Conditions
- Prostatic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Melanoma, Leukemia
- Keywords
- Neoplasms, Medication Adherence, Administration, Oral, Symptom Assessment, Neurobehavioral Manifestations, Depression, Behavioral Symptoms, Utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Care 12 weeks | Active comparator | Behavioral: Interactive Voice Response (IVR) RemindersStandard care. Standard supportive care and Toolkit given at 12 weeks. |
| Standard Care 8 wks, Daily IVR 4 wks | Experimental | Behavioral: Interactive Voice Response (IVR) RemindersInteractive Voice Response (IVR) Reminders Daily delivery for the last 4 weeks of the study. |
| Daily IVR 8 weeks | Experimental | Behavioral: Interactive Voice Response (IVR) RemindersInteractive Voice Response (IVR) Reminders daily for the first 8 weeks of the study. |
| Daily IVR 4 wk, Every other day IVR 4 wk | Experimental | Behavioral: Interactive Voice Response (IVR) RemindersInteractive Voice Response (IVR) Reminders daily for the first 4 weeks of the study and every other day for weeks 4-8. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Voice Response (IVR) RemindersReminders 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. | Behavioural | Daily IVR 4 wk, Every other day IVR 4 wk, Daily IVR 8 weeks, Standard Care 12 weeks, Standard Care 8 wks, Daily IVR 4 wks |
Primary outcome
Medication Adherence using pill count and self report
Time frame: 8 weeks
6 secondary outcomes
Medication Self-Efficacy using Horne Measure
Time frame: 8 weeks
Symptom Burden is determining the overall number of symptoms on the given symptom tool
Time frame: 8 weeks
Symptom Interference is the interference with daily activities
Time frame: 8 weeks
Depression using the full Clinical Screening for depression measure
Time frame: 8 weeks
Physical Function using the Physical Function Scale
Time frame: 8 weeks
Healthcare Utilization is the use of Emergency room and Hospital admissions
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Derived from this study: PubMed 33305993Marshall 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.
- Derived from this study: PubMed 31925414Sikorskii 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.
- Derived from this study: PubMed 30311987Decker 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.
- Individual participant dataSharing planned: No. Individual participant data will not be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Given, PhD principal investigator
Michigan State University
Charles Given, PhD principal investigator
Michigan State University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Voice Response (IVR) Reminders in people with Prostatic Neoplasms and Breast Neoplasms, run by Michigan State University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence using pill count and self report (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02043184, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.