Trial Outcomes & Findings for Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence (NCT NCT02543723)
NCT ID: NCT02543723
Last Updated: 2021-07-22
Results Overview
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.
COMPLETED
NA
128 participants
Baseline and at 6 months
2021-07-22
Participant Flow
Participant milestones
| Measure |
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.
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Control
Patients received standard of care at this Regional Cancer Center.
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|---|---|---|
|
Overall Study
STARTED
|
65
|
63
|
|
Overall Study
COMPLETED
|
65
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telehealth-based Strategies to Increase Oral Chemotherapeutic Agent Medication Adherence
Baseline characteristics by cohort
| Measure |
Nurse Coach Intervention
n=65 Participants
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.
|
Control
n=63 Participants
Patients received standard of care.
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Total
n=128 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 15.56 • n=5 Participants
|
56 years
STANDARD_DEVIATION 48.08 • n=7 Participants
|
53.25 years
STANDARD_DEVIATION 13.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
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Region of Enrollment
United States
|
65 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
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Cancer Health Literacy Test (CHLT-30)
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20.17 units on a scale
STANDARD_DEVIATION 6.36 • n=5 Participants
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20.69 units on a scale
STANDARD_DEVIATION 6.15 • n=7 Participants
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20.42 units on a scale
STANDARD_DEVIATION 6.24 • n=5 Participants
|
|
Self-efficacy for Appropriate Medication Use Scale (SEAMS)
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58.16 units on a scale
STANDARD_DEVIATION 5.62 • n=5 Participants
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58.16 units on a scale
STANDARD_DEVIATION 6 • n=7 Participants
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58.16 units on a scale
STANDARD_DEVIATION 5.8 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and at 6 monthsPopulation: Rural cancer patients taking oral cancer medications
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.
Outcome measures
| Measure |
Nurse Coach Intervention
n=65 Participants
Using the SEAMS to measure baseline and final (at 6 months)
|
Control
n=63 Participants
Using the SEAMS to measure baseline and final (at 6 months)
|
|---|---|---|
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Medication Adherence at Baseline and 6-month Follow-up Period
|
59.4 units on a scale
Standard Deviation 5.18
|
55.95 units on a scale
Standard Deviation 9.34
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SECONDARY outcome
Timeframe: Baseline and at 6 monthsPopulation: Rural cancer patients taking oral cancer medications
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.
Outcome measures
| Measure |
Nurse Coach Intervention
n=65 Participants
Using the SEAMS to measure baseline and final (at 6 months)
|
Control
n=63 Participants
Using the SEAMS to measure baseline and final (at 6 months)
|
|---|---|---|
|
Health Literacy at Baseline and 6-month Follow-up Period
|
22.95 units on a scale
Standard Deviation 4.62
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23.32 units on a scale
Standard Deviation 8.36
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Adverse Events
Nurse Coach Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place