A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer

Conditions
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Cancer, Adherence, Medication

Intervention / Treatment
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* Behavioral: Tailored Program
* Behavioral: Feedback Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Program<br>8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins | Behavioral: Tailored Program<br>* 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.<br>|
| Other: Feedback Program<br>8-week feedback program including 8 weekly texts | Behavioral: Feedback Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment Rate | Percent of approached eligible participants enrolling in the study | End of study enrollment period, approximately 12 months after enrollment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention Rate | Percent of participants completing all procedures | End of data collection period, approximately 18 months after enrollment initiation | 
| Intervention Fidelity: Contact | Percent of enrolled participants who received 4 intervention sessions | End of data collection period, approximately 18 months after enrollment initiation | 
| Intervention Fidelity: Length | Percent of enrolled participants for whom all sessions were 30-45 minutes in length | End of data collection period, approximately 18 months after enrollment initiation | 
| Intervention Fidelity: Duration | Percent of enrolled participants who completed all 4 intervention sessions during a 8-10 week period | End of data collection period, approximately 18 months after enrollment initiation | 
| Intervention Fidelity: Content | Percent of enrolled participants who received all of the planned intervention content as defined in the fidelity checklist | End of data collection period, approximately 18 months after enrollment initiation | 
| Assessment Completion | Percent of enrolled participants with complete data | End of data collection period, approximately 18 months after enrollment initiation | 
| System Usability Scale | A 10-item rating of usability | 4 weeks following treatment completion | 
| Adjective Rating Scale | 1-item rating of user friendliness | 4 weeks following treatment completion | 
| Acceptability & Adherence Scale | Rating of behavioral treatment acceptability | 4 weeks following treatment completion | 
| Medical Adherence Measure | 2-item self-report of missed doses | 4 weeks following treatment completion | 
| 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. | Starting 4 weeks prior to treatment initiation and continuing until 4 weeks following treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, adherence