An interventional study of Tailored Program and Feedback Program in Cancer and Adherence, Medication, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 3 sites in United States. Open to participants aged 15 Years to 24 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 70 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
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Exclusion Criteria:
8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins
Behavioral: Tailored Program
8-week feedback program including 8 weekly texts
Behavioral: Feedback 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.
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
Percent of approached eligible participants enrolling in the study
Time frame: End of study enrollment period, approximately 12 months after enrollment initiation
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)
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)
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)
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)
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)
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)
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
"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
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
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
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)
Of the 70 enrolled participants, 24 met inclusion criteria and were randomized to one of the two intervention conditions
| Milestone | Tailored Program | Feedback Program |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
Percent of approached eligible participants enrolling in the study
| Participants | Overall |
|---|---|
| Enrollment Rate | 70 |
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)
| Participants | Overall |
|---|---|
| Retention Rate | 56 |
Percent of participants randomized to the Tailored Program who completed 4 intervention sessions
| Participants | Tailored Program | Feedback Program |
|---|---|---|
| Intervention Fidelity: Contact | 10 | — |
Percent of participants randomized to the Tailored Program for whom all sessions were 30-45 minutes in length
| Participants | Tailored Program | Feedback Program |
|---|---|---|
| Intervention Fidelity: Length | 8 | — |
Percent of randomized to the Tailored Program who completed all 4 intervention sessions during a 8-10 week period
| Participants | Tailored Program | Feedback Program |
|---|---|---|
| Intervention Fidelity: Duration | 10 | — |
Percent of participants randomized to the Tailored Program who received all of the planned intervention content as defined in the fidelity checklist
| Participants | Tailored Program | Feedback Program |
|---|---|---|
| Intervention Fidelity: Content | 12 | — |
Percent of enrolled participants with complete data
| Participants | Tailored Program | Feedback Program |
|---|---|---|
| Assessment Completion | 12 | 12 |
A 10-item rating of usability, range = 0-100, better scores indicate better usability
| score on a scale | Tailored Program | Feedback Program |
|---|---|---|
| System Usability Scale | 80.42 ± 13.05 | 81.25 ± 11.15 |
1-item rating of user friendliness, range = 1 (worst imaginable) to 7 (best imaginable), higher scores indicate better usability
| score on a scale | Tailored Program | Feedback Program |
|---|---|---|
| "Adjective Rating Scale" (Measure of Usability) | 5.92 ± 1.08 | 5.75 ± 0.97 |
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)
| Participants | Tailored Program | Feedback Program |
|---|---|---|
| Number of Participants Rating Behavioral Treatment Acceptability as 4 or Greater | 11 | 8 |
1-item self-report of missed doses
| percentage of doses taken | Tailored Program | Feedback Program |
|---|---|---|
| Medical Adherence Measure | 97.62 ± 5.56 | 90.28 ± 15.71 |
Each participant will be given an electronic monitoring device to store their medication. The electronic monitoring device records each time the device is opened.
| percentage of doses taken | Tailored Program | Feedback Program |
|---|---|---|
| Electronically Monitored Medication Adherence | 85.44 ± 14.38 | 63.25 ± 30.84 |
Collected over 4 month study period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tailored Program | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Feedback Program | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | Tailored Program | Feedback Program | Total |
|---|---|---|---|
| Mean | 19.25 ± 2.47 | 18.73 ± 2.50 | 18.99 ± 2.44 |
| Sex: Female, Male(Participants) | Tailored Program | Feedback Program | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 9 | 8 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Tailored Program | Feedback Program | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 9 | 10 | 19 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Tailored Program | Feedback Program | Total |
|---|---|---|---|
| Black or African American | 1 | 0 | 1 |
| More the one race | 0 | 1 | 1 |
| Other race | 1 | 0 | 1 |
| White | 9 | 10 | 19 |
| I don't know | 1 | 1 | 2 |
| Region of Enrollment(participants) | Tailored Program | Feedback Program | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
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Children's Hospital Medical Center, Cincinnati