Trial Outcomes & Findings for A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer (NCT NCT05706610)
NCT ID: NCT05706610
Last Updated: 2025-12-02
Results Overview
Percent of approached eligible participants enrolling in the study
COMPLETED
NA
70 participants
End of study enrollment period, approximately 12 months after enrollment initiation
2025-12-02
Participant Flow
Of the 70 enrolled participants, 24 met inclusion criteria and were randomized to one of the two intervention conditions
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer
Baseline characteristics by cohort
| Measure |
Tailored Program
n=12 Participants
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.
|
Feedback Program
n=12 Participants
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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.25 years
STANDARD_DEVIATION 2.47 • n=9 Participants
|
18.73 years
STANDARD_DEVIATION 2.50 • n=6 Participants
|
18.99 years
STANDARD_DEVIATION 2.44 • n=9 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
17 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
19 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
More the one race
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Other race
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
19 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
I don't know
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=9 Participants
|
12 participants
n=6 Participants
|
24 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: End of study enrollment period, approximately 12 months after enrollment initiationPercent of approached eligible participants enrolling in the study
Outcome measures
| Measure |
Overall
n=77 Participants
Enrollment and retention were calculated at the study level
|
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.
|
|---|---|---|
|
Enrollment Rate
|
70 Participants
|
—
|
SECONDARY outcome
Timeframe: 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).
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)
Outcome measures
| Measure |
Overall
n=65 Participants
Enrollment and retention were calculated at the study level
|
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.
|
|---|---|---|
|
Retention Rate
|
56 Participants
|
—
|
SECONDARY outcome
Timeframe: 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
Percent of participants randomized to the Tailored Program who completed 4 intervention sessions
Outcome measures
| Measure |
Overall
n=10 Participants
Enrollment and retention were calculated at the study level
|
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.
|
|---|---|---|
|
Intervention Fidelity: Contact
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Percent of participants randomized to the Tailored Program for whom all sessions were 30-45 minutes in length
Outcome measures
| Measure |
Overall
n=12 Participants
Enrollment and retention were calculated at the study level
|
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.
|
|---|---|---|
|
Intervention Fidelity: Length
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: 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
Percent of randomized to the Tailored Program who completed all 4 intervention sessions during a 8-10 week period
Outcome measures
| Measure |
Overall
n=10 Participants
Enrollment and retention were calculated at the study level
|
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.
|
|---|---|---|
|
Intervention Fidelity: Duration
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: 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
Percent of participants randomized to the Tailored Program who received all of the planned intervention content as defined in the fidelity checklist
Outcome measures
| Measure |
Overall
n=12 Participants
Enrollment and retention were calculated at the study level
|
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.
|
|---|---|---|
|
Intervention Fidelity: Content
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Overall
n=12 Participants
Enrollment and retention were calculated at the study level
|
Feedback Program
n=12 Participants
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.
|
|---|---|---|
|
Assessment Completion
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollmentA 10-item rating of usability, range = 0-100, better scores indicate better usability
Outcome measures
| Measure |
Overall
n=12 Participants
Enrollment and retention were calculated at the study level
|
Feedback Program
n=12 Participants
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.
|
|---|---|---|
|
System Usability Scale
|
80.42 score on a scale
Standard Deviation 13.05
|
81.25 score on a scale
Standard Deviation 11.15
|
SECONDARY outcome
Timeframe: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment1-item rating of user friendliness, range = 1 (worst imaginable) to 7 (best imaginable), higher scores indicate better usability
Outcome measures
| Measure |
Overall
n=12 Participants
Enrollment and retention were calculated at the study level
|
Feedback Program
n=12 Participants
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.
|
|---|---|---|
|
"Adjective Rating Scale" (Measure of Usability)
|
5.92 score on a scale
Standard Deviation 1.08
|
5.75 score on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollmentRating 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)
Outcome measures
| Measure |
Overall
n=12 Participants
Enrollment and retention were calculated at the study level
|
Feedback Program
n=12 Participants
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.
|
|---|---|---|
|
Number of Participants Rating Behavioral Treatment Acceptability as 4 or Greater
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment1-item self-report of missed doses
Outcome measures
| Measure |
Overall
n=12 Participants
Enrollment and retention were calculated at the study level
|
Feedback Program
n=12 Participants
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.
|
|---|---|---|
|
Medical Adherence Measure
|
97.62 percentage of doses taken
Standard Deviation 5.56
|
90.28 percentage of doses taken
Standard Deviation 15.71
|
SECONDARY outcome
Timeframe: 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
Each participant will be given an electronic monitoring device to store their medication. The electronic monitoring device records each time the device is opened.
Outcome measures
| Measure |
Overall
n=10 Participants
Enrollment and retention were calculated at the study level
|
Feedback Program
n=12 Participants
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.
|
|---|---|---|
|
Electronically Monitored Medication Adherence
|
85.44 percentage of doses taken
Standard Deviation 14.38
|
63.25 percentage of doses taken
Standard Deviation 30.84
|
Adverse Events
Tailored Program
Feedback Program
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Meghan McGrady
Cincinnati Children's Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place