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| ID | Type | Description | Link |
|---|---|---|---|
| R37CA302422 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Seattle Children's Hospital | OTHER |
| University of Kansas Medical Center | OTHER |
| Columbia University |
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The goal of this clinical trial is to learn if a tailored intervention can help make it easier for adolescents and young adults with cancer to take their medications. The main questions the researchers are trying to answer are:
The researchers will compare the tailored intervention to a uniform standard of care intervention (an intervention designed to be similar to what is currently happening in clinical care) to see if the tailored intervention works to improve adherence.
Participants will:
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. As part of this study, up to 160 adolescents and young adults (AYAs) with cancer will be randomized to one of these groups. Participants who enroll in this trial will be given an electronic pill bottle or box with a computer chip to store their medication. After using the electronic monitor for a few 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 one of the two groups and complete their assigned program. 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 questionnaires at post-treatment and again about 6 months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored Program | Experimental | 8-week program including 4 coach visits and 4 text check-ins |
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| Feedback Program (Uniform Standard of Care) | Other | 8-week feedback program including weekly texts |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored Program | Behavioral | Participants will participate in 4 sessions with a coach, 1 every other week. During these sessions, the participant will work with their coach to identify a barrier to adherence they would like to target. Then, they will work with their coach to 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 reminder about the plan. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence | Each participant will be given an electronic adherence monitoring device to store their medication. An electronic adherence monitoring device is a pill bottle or box with an embedded computer chip. The computer chip records each time the device is opened. These device openings, or actuations, will be compared with the patient's prescribed medication regimen to compute their adherence (defined as the percentage of doses taken as prescribed). | The 1-month period following the completion of one of the study programs. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (Mental Health) | PROMIS (Patient-Reported Outcomes Measurement Information System) Global Mental Health 2a. Raw score range = 2-10. Higher scores = better quality of life. | Approximately 1 month after completing one of the study programs |
| Quality of Life (Physical Health) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meghan E. McGrady, PhD | Contact | 513-803-8044 | Meghan.McGrady@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Meghan E. McGrady, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| OTHER |
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| Feedback Program (Uniform Standard of Care) | Behavioral | Participants will receive weekly text messages with feedback about their adherence and guidance for requesting additional support if desired |
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PROMIS (Patient-Reported Outcomes Measurement Information System) Global Physical Health 2a. Raw score range = 2-10. Higher scores = better quality of life. |
| Approximately 1 month after completing one of the study programs |
| Healthcare Utilization | Number of oncology visits, lab draws, ED visits, and hospitalizations | 6 months post-treatment |
| Columbia University Irving Medical Center | New York | New York | 1003230702 | United States |
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| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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