Medication AdherenceNCT02543723
Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence
A study testing Nurse Coach Intervention in people with Medication Adherence, run by East Carolina University at 1 site in United States.
Trial summary
Oral chemotherapeutic agents (OCAs) are increasingly being used as an alternative to traditional intravenous chemotherapy, and factors promoting this trend include increased survival times requiring long-term therapy, acceptability among patients, convenience, and cost savings due to reduced hospital time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Nurse Coach Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2015to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New cycle or withing the first 3 cycles of OCAs
- Ambulatory
- Age 18 years or older
- Able to consent for self
- Able to read and speak English
- Has a working cellphone or landline.
Who cannot join
- Life expectancy <3 months as determined by oncologist
- Current participation in a similar study or in investigational drug trials where adverse effects have not been fully elucidated
- Presence of significant psychiatric or cognitive impairments as determined by oncologists and study teams.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vidant Medical Center
Greenville, North Carolina, 27587
About this study
Official title: A Randomized Longitudinal Intervention Study to Assess the Efficacy and Feasibility of Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence and Health Literacy Among Cancer Patients.
Oral chemotherapeutic agents (OCAs) are increasingly being used as an alternative to traditional intravenous chemotherapy, and factors promoting this trend include increased survival times requiring long-term therapy, acceptability among patients, convenience, and cost savings due to reduced hospital time. Although OCAs are commonly preferred by patients, adherence to these medications vary. Suboptimal medication adherence leads to loss of treatment efficacy, increased toxicity, and increased health care costs. Thus, it is critical to develop and test interventions that effectively improve adherence to OCAs. Although the medication adherence literature has been criticized for methodological issues, some components of interventions have had promising results on adherence such as electronic monitored adherence feedback, cognitive-education, nurse-based interventions, and technology-based or telehealth strategies. The investigators propose to unify components of these effective approaches in a novel way to assess the efficacy and feasibility of two telehealth-based strategies (electronic medication-event monitoring with feedback and tailored nurse coaching which includes cognitive-education) in an effort increase OCA adherence among cancer patients who are at high-risk for non-adherence in rural eastern North Carolina.
Read the detailed description
The purpose of this study is to improve cancer patient's adherence to their oral chemotherapy agents. We want to test whether a tailored nurse coaching intervention will significantly improve medication adherence as compared to a control group (standard-of-care). With strong support from our collaborators at the Vidant Cancer Care - Eddie and Jo Allison Smith Tower at Vidant Medical Center (VCC), study participants included cancer patients that were within their first two cycles of a new oral chemotherapy regimen at Vidant Medical Center/Leo W. Jenkins Cancer Center, which serves individuals throughout the 29 counties in rural eastern North Carolina (ENC).
Study Objectives:
Objective 1: To assess the barriers to, and facilitators of, adherence to oral chemotherapeutic agents among cancer patients who are at high-risk of non-adherence. Using the three-stage process of elicitation, intervention, and evaluation, we assessed factors that influenced non-adherence among this population. This formative qualitative assessment was accomplished by conducting interviews with English speaking cancer patients (N=25) and through key informant interviews/focus groups with cancer care providers (N=10). Objective 1 served as a baseline assessment to identify the unique factors that contribute to non-adherence and directly informed the development of tailored medication adherence strategies outlined in objective 2.
Objective 2. To test the effectiveness a telehealth adherence motivation strategy among cancer patients on oral chemotherapeutic agents who are at high-risk of non-adherence.
We conducted a randomized control trial study of 150 subjects where subjects were randomly assigned to control or intervention arm. The Information-Motivation-Behavioral Skills Model of Adherence and the results of objective 1 guided this aim. Controls received the standard-of-care. The intervention arm received the standard-of-care and the nurse coach intervention. Specifically, we assessed whether a tailored nurse coaching intervention component will significantly improve medication adherence at higher rates as compared to the control group. The nurse coach intervention component involved individualized barriers/facilitators screening tool, educational tools, and regular contact with cancer patients via telephone calls across a six-month period. We hypothesize that the nurse-coach intervention would be effective at increasing medication adherence. This hypothesis is supported by existing medication adherence literature that suggests a tailored intervention using multiple adherence strategies can potentially have a significant impact on increasing medication adherence.
- Conditions
- Medication Adherence
- Being tested
- Nurse Coach Intervention
- Keywords
- medication adherence, telehealth strategies, nurse coaching
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Coach InterventionBehavioural
Participants randomized to the intervention 2 group a tailored nurse coach component. Participants will receive an initial session conducted by the nurse coach, via phone or in-person. Participants will receive weekly phone calls from the nurse coach during the first month of the intervention, and then bi-monthly follow-up calls for the remainder of treatment or 6-month follow-up period (whichever occurs first). The nurse coach will modify the intervention plan to address identified barriers to adherence at this time.
| Study group | Role | What they receive |
|---|---|---|
| Nurse Coach Intervention | Active comparator | The nurse coach conducted an initial assessment with the participant and identified specific adherence strategies tailored to the participant's needs. The educational strategies include information about the patient's cancer treatment and expected outcomes; clear instructions about medication dosing schedule; what to do if a dose is missed or delayed; medication side effects and/or potential drug interactions; and review of cancer health literacy infographics. The behavioral skills and affective support strategies include coping strategies for side effects, skills for fitting medication regimen into daily routine, identifying a support network, communication skills for interacting with providers, and facilitating a positive perception for effective self-management experience. Patients received weekly phone calls from the nurse coach during the first month of the intervention, and then bi-monthly follow-up calls for the remainder of treatment or 6-month follow-up period. Receives: Behavioral: Nurse Coach Intervention |
| Control | No intervention | Patients received standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence at Baseline and 6-month Follow-up Period
The participant's cancer medication adherence was taken at baseline and within a 6-month follow-up period. We measured the participant's self-efficacy with medication adherence increase with their OCAs using the SEAMS scale.
SEAMS Scale: 21 items scale, ranges from 21-63, higher scores indicate higher level of self-efficacy for medication adherence.
Measured: Baseline and at 6 months
Secondary outcomes (1)
Health Literacy at Baseline and 6-month Follow-up Period
We measured the participant's cancer health literacy at baseline and at 6 months via the CHLT-30.
The CHLT-30 measures cancer health literacy along a continuum with 0-30 representing the number of correct answers provided to the items. Continuous scores provided by the CHLT-30 do not allow to determine who has limited health literacy or put people in a category, with higher scores indicating a higher degree of cancer health literacy.
Measured: Baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study start15 Nov 2015
- Primary completion30 Mar 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Medication AdherenceStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We conducted a randomized control trial study of 150 subjects where subjects were randomly assigned to control or intervention arm. The Information-Motivation-Behavioral Skills Model of Adherence and the results of objective 1 guided this aim. Controls received the standard-of-care . The intervention arm received the standard-of-care and the nurse coach intervention. Specifically, we assessed whether a tailored nurse coaching intervention component will significantly improve medication adherence at higher rates as compared to the control group. The nurse coach intervention component involved individualized barriers/facilitators screening tool, educational tools, and regular contact with cancer patients via telephone calls across a six-month period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essie Torres, East Carolina University
- Investigators
- Essie Torres, PhD, MPH, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543723
- Sponsor's protocol ID
- 53517
- Status last verified
- Jul 2021
- First submitted
- 3 Sep 2015
- Last updated
- 22 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Longitudinal Intervention Study to Assess the Efficacy and Feasibility of Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence and Health Literacy Among Cancer Patients.
- ClinicalTrials.gov ID
- NCT02543723
- Acronym / sponsor ID
- 53517
- Conditions
- Medication Adherence
- Keywords
- medication adherence, telehealth strategies, nurse coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 15 Nov 2015 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 19 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral chemotherapeutic agents (OCAs) are increasingly being used as an alternative to traditional intravenous chemotherapy, and factors promoting this trend include increased survival times requiring long-term therapy, acceptability among patients, convenience, and cost savings due to reduced hospital time. Although OCAs are commonly preferred by patients, adherence to these medications vary. Suboptimal medication adherence leads to loss of treatment efficacy, increased toxicity, and increased health care costs. Thus, it is critical to develop and test interventions that effectively improve adherence to OCAs. Although the medication adherence literature has been criticized for methodological issues, some components of interventions have had promising results on adherence such as electronic monitored adherence feedback, cognitive-education, nurse-based interventions, and technology-based or telehealth strategies. The investigators propose to unify components of these effective approaches in a novel way to assess the efficacy and feasibility of two telehealth-based strategies (electronic medication-event monitoring with feedback and tailored nurse coaching which includes cognitive-education) in an effort increase OCA adherence among cancer patients who are at high-risk for non-adherence in rural eastern North Carolina.
Detailed description
The purpose of this study is to improve cancer patient's adherence to their oral chemotherapy agents. We want to test whether a tailored nurse coaching intervention will significantly improve medication adherence as compared to a control group (standard-of-care). With strong support from our collaborators at the Vidant Cancer Care - Eddie and Jo Allison Smith Tower at Vidant Medical Center (VCC), study participants included cancer patients that were within their first two cycles of a new oral chemotherapy regimen at Vidant Medical Center/Leo W. Jenkins Cancer Center, which serves individuals throughout the 29 counties in rural eastern North Carolina (ENC).
Study Objectives:
Objective 1: To assess the barriers to, and facilitators of, adherence to oral chemotherapeutic agents among cancer patients who are at high-risk of non-adherence. Using the three-stage process of elicitation, intervention, and evaluation, we assessed factors that influenced non-adherence among this population. This formative qualitative assessment was accomplished by conducting interviews with English speaking cancer patients (N=25) and through key informant interviews/focus groups with cancer care providers (N=10). Objective 1 served as a baseline assessment to identify the unique factors that contribute to non-adherence and directly informed the development of tailored medication adherence strategies outlined in objective 2.
Objective 2. To test the effectiveness a telehealth adherence motivation strategy among cancer patients on oral chemotherapeutic agents who are at high-risk of non-adherence.
We conducted a randomized control trial study of 150 subjects where subjects were randomly assigned to control or intervention arm. The Information-Motivation-Behavioral Skills Model of Adherence and the results of objective 1 guided this aim. Controls received the standard-of-care. The intervention arm received the standard-of-care and the nurse coach intervention. Specifically, we assessed whether a tailored nurse coaching intervention component will significantly improve medication adherence at higher rates as compared to the control group. The nurse coach intervention component involved individualized barriers/facilitators screening tool, educational tools, and regular contact with cancer patients via telephone calls across a six-month period. We hypothesize that the nurse-coach intervention would be effective at increasing medication adherence. This hypothesis is supported by existing medication adherence literature that suggests a tailored intervention using multiple adherence strategies can potentially have a significant impact on increasing medication adherence.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- We conducted a randomized control trial study of 150 subjects where subjects were randomly assigned to control or intervention arm. The Information-Motivation-Behavioral Skills Model of Adherence and the results of objective 1 guided this aim. Controls received the standard-of-care . The intervention arm received the standard-of-care and the nurse coach intervention. Specifically, we assessed whether a tailored nurse coaching intervention component will significantly improve medication adherence at higher rates as compared to the control group. The nurse coach intervention component involved individualized barriers/facilitators screening tool, educational tools, and regular contact with cancer patients via telephone calls across a six-month period.
| Arm | Type | Receives |
|---|---|---|
| Nurse Coach Intervention | Active comparator | Behavioral: Nurse Coach InterventionThe nurse coach conducted an initial assessment with the participant and identified specific adherence strategies tailored to the participant's needs. The educational strategies include information about the patient's cancer treatment and expected outcomes; clear instructions about medication dosing schedule; what to do if a dose is missed or delayed; medication side effects and/or potential drug interactions; and review of cancer health literacy infographics. The behavioral skills and affective support strategies include coping strategies for side effects, skills for fitting medication regimen into daily routine, identifying a support network, communication skills for interacting with providers, and facilitating a positive perception for effective self-management experience. Patients received weekly phone calls from the nurse coach during the first month of the intervention, and then bi-monthly follow-up calls for the remainder of treatment or 6-month follow-up period. |
| Control | No intervention | –Patients received standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- New cycle or withing the first 3 cycles of OCAs
- Ambulatory
- Age 18 years or older
- Able to consent for self
- Able to read and speak English
Key exclusion criteria (3 listed)
- Life expectancy <3 months as determined by oncologist
- Current participation in a similar study or in investigational drug trials where adverse effects have not been fully elucidated
- Presence of significant psychiatric or cognitive impairments as determined by oncologists and study teams.
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 |
|---|---|---|
| Nurse Coach InterventionParticipants randomized to the intervention 2 group a tailored nurse coach component. Participants will receive an initial session conducted by the nurse coach, via phone or in-person. Participants will receive weekly phone calls from the nurse coach during the first month of the intervention, and then bi-monthly follow-up calls for the remainder of treatment or 6-month follow-up period (whichever occurs first). The nurse coach will modify the intervention plan to address identified barriers to adherence at this time. | Behavioural | Nurse Coach Intervention |
Primary outcome
Medication Adherence at Baseline and 6-month Follow-up Period
Time frame: Baseline and at 6 months
The participant's cancer medication adherence was taken at baseline and within a 6-month follow-up period. We measured the participant's self-efficacy with medication adherence increase with their OCAs using the SEAMS scale. SEAMS Scale: 21 items scale, ranges from 21-63, higher scores indicate higher level of self-efficacy for medication adherence.
1 secondary outcome
Health Literacy at Baseline and 6-month Follow-up Period
Time frame: Baseline and at 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Essie Torres, PhD, MPH principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Coach Intervention in people with Medication Adherence, run by East Carolina University at 1 site 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 3 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 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 19 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 at Baseline and 6-month Follow-up Period (time frame: Baseline and at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2021.