Adherence, Medication, Cancer
Conditions
Keywords
cancer, adherence
Brief summary
A pilot feasibility randomized clinical trial comparing a tailored intervention to uniform standard of care will be conducted. A total of 40 AYAs with cancer will be randomized to one of the two programs. Data will be collected to explore the hypotheses that the intervention meets pre-established enrollment, retention, fidelity, and data completion feasibility criteria and that AYAs will rate the intervention as easy to use and acceptable.
Detailed description
The proposed research includes a randomized clinical trial of a tailored adherence-promotion intervention (Tailored Program) as compared to uniform standard of care (Feedback Program) for adolescents and young adults with cancer. Up to 40 adolescents and young adults (AYAs) with cancer will be enrolled in this study. Participants who enroll in this trial will be given an eCAP electronic monitor, a pill bottle with a computer chip in the cap, to store their medication. After using the electronic monitor for 4 weeks to assess baseline adherence, participants who demonstrate non-adherence and have used the electronic monitor without difficulty will be asked to complete pre-treatment questionnaires. Next, participants will be randomly assigned to either the tailored adherence-promotion intervention group (Tailored Program) or the uniform standard of care group (Feedback Program). Participants will be assigned in a 1:1 ratio so that, at the end of the study, an equal number of participants will have been randomized to each group. Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. Adolescents and young adults will continue to use the electronic monitor to store their medication until approximately a month after their program ends. After their program ends, participants will complete post-treatment questionnaires regarding program usability and acceptability as well as their adherence.
Interventions
BEHAVIORALTailored Program
Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data.
BEHAVIORALFeedback Program
Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired.
Sponsors
St. Jude Children's Research Hospital
Seattle Children's Hospital
University of Cincinnati
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* Patient between 15 and 24 years of age * Patient diagnosis of cancer * Patient prescribed oral chemotherapy or prophylactic medication
Exclusion criteria
* Patient is not fluent in English * Patient evidences significant cognitive deficits per medical team * Patient's medical status or treatment precludes participation per medical team, patient, or caregiver * Patient demonstrates greater than or equal to 95% adherence during run-in period * Patient declines to use electronic monitoring device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate | End of study enrollment period, approximately 12 months after enrollment initiation | Percent of approached eligible participants enrolling in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Fidelity: Contact | From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks) | Percent of participants randomized to the Tailored Program who completed 4 intervention sessions |
| Intervention Fidelity: Length | From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks) | Percent of participants randomized to the Tailored Program for whom all sessions were 30-45 minutes in length |
| Intervention Fidelity: Duration | From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks) | Percent of randomized to the Tailored Program who completed all 4 intervention sessions during a 8-10 week period |
| Intervention Fidelity: Content | From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks) | Percent of participants randomized to the Tailored Program who received all of the planned intervention content as defined in the fidelity checklist |
| Assessment Completion | From enrollment to the completion of post-intervention assessment which occurred approximately 4 weeks after program completion (total time frame = approximately 16 weeks) | Percent of enrolled participants with complete data |
| Retention Rate | From enrollment to study completion (approximately 4 weeks for patients deemed ineligible after run-in and approximately 16 weeks for patients deemed eligible after run-in) | The percent of participants completing all procedures for which they were eligible The numerator is calculated via the following formula: (n AYAs eligible to complete at least some study procedures \[n enrolled AYAs - n AYAs meeting criteria for unenrollment prior to study start\] - n AYAs who never started study procedures - n AYAs who did not complete at least some study procedures) The denominator (n AYAs eligible to complete at least some study procedures) is calculated via the following formula: (n enrolled AYAs - n AYAs meeting criteria for unenrollment prior to study start) |
| Adjective Rating Scale (Measure of Usability) | Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment | 1-item rating of user friendliness, range = 1 (worst imaginable) to 7 (best imaginable), higher scores indicate better usability |
| Number of Participants Rating Behavioral Treatment Acceptability as 4 or Greater | Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment | Rating of behavioral treatment acceptability - I would recommend this program to other adolescents and young adults; Possible range = 1 (strongly disagree) - 5 (strongly agree), better scores represent better acceptability; Dichotomous variable created representing whether participants scored this item as 1-3 (not acceptable) or 4-5 (acceptable) |
| Medical Adherence Measure | Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment | 1-item self-report of missed doses |
| Electronically Monitored Medication Adherence | Starting 4 weeks prior to treatment initiation (approximately weeks 1-4) and continuing until 4 weeks after program completion (approximately weeks 12-16) | Each participant will be given an electronic monitoring device to store their medication. The electronic monitoring device records each time the device is opened. |
| System Usability Scale | Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment | A 10-item rating of usability, range = 0-100, better scores indicate better usability |
Countries
United States
Participant flow
Recruitment details
Of the 70 enrolled participants, 24 met inclusion criteria and were randomized to one of the two intervention conditions
Participants by arm
| Arm | Count |
|---|---|
| Tailored Program 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins
Tailored Program: Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. | 12 |
| Feedback Program 8-week feedback program including 8 weekly texts
Feedback Program: Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Tailored Program | Feedback Program | Total |
|---|---|---|---|
| Age, Continuous | 19.25 years STANDARD_DEVIATION 2.47 | 18.73 years STANDARD_DEVIATION 2.5 | 18.99 years STANDARD_DEVIATION 2.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 10 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized I don't know | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized More the one race | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other race | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 9 Participants | 10 Participants | 19 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Enrollment Rate
Percent of approached eligible participants enrolling in the study
Time frame: End of study enrollment period, approximately 12 months after enrollment initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall | Enrollment Rate | 70 Participants |
Secondary
Adjective Rating Scale (Measure of Usability)
1-item rating of user friendliness, range = 1 (worst imaginable) to 7 (best imaginable), higher scores indicate better usability
Time frame: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Adjective Rating Scale (Measure of Usability) | 5.92 score on a scale | Standard Deviation 1.08 |
| Feedback Program | Adjective Rating Scale (Measure of Usability) | 5.75 score on a scale | Standard Deviation 0.97 |
Secondary
Assessment Completion
Percent of enrolled participants with complete data
Time frame: From enrollment to the completion of post-intervention assessment which occurred approximately 4 weeks after program completion (total time frame = approximately 16 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall | Assessment Completion | 12 Participants |
| Feedback Program | Assessment Completion | 12 Participants |
Secondary
Electronically Monitored Medication Adherence
Each participant will be given an electronic monitoring device to store their medication. The electronic monitoring device records each time the device is opened.
Time frame: Starting 4 weeks prior to treatment initiation (approximately weeks 1-4) and continuing until 4 weeks after program completion (approximately weeks 12-16)
Population: Two participants had their medication discontinued prior to the end of the study period and thus do not have electronic adherence monitoring device data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Electronically Monitored Medication Adherence | 85.44 percentage of doses taken | Standard Deviation 14.38 |
| Feedback Program | Electronically Monitored Medication Adherence | 63.25 percentage of doses taken | Standard Deviation 30.84 |
Secondary
Intervention Fidelity: Contact
Percent of participants randomized to the Tailored Program who completed 4 intervention sessions
Time frame: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Population: This outcome is relevant to the Tailored Program only. Data from 2 participants who met criteria for unenrollment during the Tailored Program, and thus received fewer than 4 sessions due to no longer being eligible, are not included
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall | Intervention Fidelity: Contact | 10 Participants |
Secondary
Intervention Fidelity: Content
Percent of participants randomized to the Tailored Program who received all of the planned intervention content as defined in the fidelity checklist
Time frame: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Population: This outcome is relevant to participants randomized to the tailored program only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall | Intervention Fidelity: Content | 12 Participants |
Secondary
Intervention Fidelity: Duration
Percent of randomized to the Tailored Program who completed all 4 intervention sessions during a 8-10 week period
Time frame: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Population: This outcome is relevant to the Tailored Program only. Data from 2 participants who met criteria for unenrollment during the Tailored Program, and thus received fewer than 4 sessions due to no longer being eligible, are not included
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall | Intervention Fidelity: Duration | 10 Participants |
Secondary
Intervention Fidelity: Length
Percent of participants randomized to the Tailored Program for whom all sessions were 30-45 minutes in length
Time frame: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Population: This outcome is relevant to the Tailored Program only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall | Intervention Fidelity: Length | 8 Participants |
Secondary
Medical Adherence Measure
1-item self-report of missed doses
Time frame: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Medical Adherence Measure | 97.62 percentage of doses taken | Standard Deviation 5.56 |
| Feedback Program | Medical Adherence Measure | 90.28 percentage of doses taken | Standard Deviation 15.71 |
Secondary
Number of Participants Rating Behavioral Treatment Acceptability as 4 or Greater
Rating of behavioral treatment acceptability - I would recommend this program to other adolescents and young adults; Possible range = 1 (strongly disagree) - 5 (strongly agree), better scores represent better acceptability; Dichotomous variable created representing whether participants scored this item as 1-3 (not acceptable) or 4-5 (acceptable)
Time frame: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall | Number of Participants Rating Behavioral Treatment Acceptability as 4 or Greater | 11 Participants |
| Feedback Program | Number of Participants Rating Behavioral Treatment Acceptability as 4 or Greater | 8 Participants |
Secondary
Retention Rate
The percent of participants completing all procedures for which they were eligible The numerator is calculated via the following formula: (n AYAs eligible to complete at least some study procedures \[n enrolled AYAs - n AYAs meeting criteria for unenrollment prior to study start\] - n AYAs who never started study procedures - n AYAs who did not complete at least some study procedures) The denominator (n AYAs eligible to complete at least some study procedures) is calculated via the following formula: (n enrolled AYAs - n AYAs meeting criteria for unenrollment prior to study start)
Time frame: From enrollment to study completion (approximately 4 weeks for patients deemed ineligible after run-in and approximately 16 weeks for patients deemed eligible after run-in)
Population: In all, 65 AYAs were eligible to complete at least some study procedures (70 enrolled - 5 meeting criteria for unenrollment prior to start = 65). Of these, 56 (65 - 8 AYAs who never started - 1 AYA who did not complete at least some study procedures = 56) completed all study procedures for which they were eligible, resulting in a retention rate of 86% (56/65).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall | Retention Rate | 56 Participants |
Secondary
System Usability Scale
A 10-item rating of usability, range = 0-100, better scores indicate better usability
Time frame: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | System Usability Scale | 80.42 score on a scale | Standard Deviation 13.05 |
| Feedback Program | System Usability Scale | 81.25 score on a scale | Standard Deviation 11.15 |