Medication Adherence
Conditions
Keywords
medication adherence, telehealth strategies, nurse coaching
Brief 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. 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.
Interventions
BEHAVIORALNurse Coach Intervention
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.
Sponsors
East Carolina University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
Participants were randomized into the control or intervention group.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. New cycle or withing the first 3 cycles of OCAs 2. Ambulatory 3. Age 18 years or older 4. Able to consent for self 5. Able to read and speak English 6. Has a working cellphone or landline.
Exclusion criteria
1. Life expectancy \<3 months as determined by oncologist 2. Current participation in a similar study or in investigational drug trials where adverse effects have not been fully elucidated 3. Presence of significant psychiatric or cognitive impairments as determined by oncologists and study teams.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence at Baseline and 6-month Follow-up Period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Literacy at Baseline and 6-month Follow-up Period | Baseline and at 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nurse Coach Intervention 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. | 65 |
| Control Patients received standard of care. | 63 |
| Total | 128 |
Baseline characteristics
| Characteristic | Total | Nurse Coach Intervention | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 61 Participants | 30 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 35 Participants | 32 Participants |
| Age, Continuous | 53.25 years STANDARD_DEVIATION 13.75 | 50.5 years STANDARD_DEVIATION 15.56 | 56 years STANDARD_DEVIATION 48.08 |
| Cancer Health Literacy Test (CHLT-30) | 20.42 units on a scale STANDARD_DEVIATION 6.24 | 20.17 units on a scale STANDARD_DEVIATION 6.36 | 20.69 units on a scale STANDARD_DEVIATION 6.15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 63 Participants | 33 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 62 Participants | 29 Participants | 33 Participants |
| Region of Enrollment United States | 128 Participants | 65 Participants | 63 Participants |
| Self-efficacy for Appropriate Medication Use Scale (SEAMS) | 58.16 units on a scale STANDARD_DEVIATION 5.8 | 58.16 units on a scale STANDARD_DEVIATION 5.62 | 58.16 units on a scale STANDARD_DEVIATION 6 |
| Sex: Female, Male Female | 66 Participants | 35 Participants | 31 Participants |
| Sex: Female, Male Male | 62 Participants | 30 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 11 / 65 | 15 / 63 |
| other Total, other adverse events | 0 / 65 | 0 / 63 |
| serious Total, serious adverse events | 0 / 65 | 0 / 63 |
Outcome results
Primary
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.
Time frame: Baseline and at 6 months
Population: Rural cancer patients taking oral cancer medications
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse Coach Intervention | Medication Adherence at Baseline and 6-month Follow-up Period | 59.4 units on a scale | Standard Deviation 5.18 |
| Control | Medication Adherence at Baseline and 6-month Follow-up Period | 55.95 units on a scale | Standard Deviation 9.34 |
Secondary
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.
Time frame: Baseline and at 6 months
Population: Rural cancer patients taking oral cancer medications
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse Coach Intervention | Health Literacy at Baseline and 6-month Follow-up Period | 22.95 units on a scale | Standard Deviation 4.62 |
| Control | Health Literacy at Baseline and 6-month Follow-up Period | 23.32 units on a scale | Standard Deviation 8.36 |