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This is a single center 2-phase study to assess effects of using text messages on adherence to oral chemotherapy for patients with acute lymphoblastic leukemia (ALL) or T-cell lymphoblastic lymphoma.
The study will begin with a 28-day pilot phase where participants will be asked to complete questionnaires to determine if the text message intervention is acceptable to participants.
In the efficacy phase, the study will compare adherence to oral mercaptopurine and methotrexate between those who receive the high intensity text message intervention and those who receive standard-of-care. It is believed that high-intensity text messages will increase patient adherence within cycle 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efficacy Phase: High Intensity Messaging | Active Comparator | Receives high-intensity text messaging for 2 cycles of treatment |
|
| Efficacy Phase: Low Intensity Messaging | Active Comparator | Receives no texts for 1st cycle and low-intensity texts for 2nd cycle |
|
| Pilot Phase Arm | Experimental | Participants receive high-intensity text messaging for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity | Other | Daily texts |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare adherence to oral chemotherapy between study groups for first treatment cycle (Efficacy Phase) | Adherence to chemotherapy regimen will be measured based on combined data from 8.1 Medication Event Monitoring System (MEMS) TrackCap devices which measure the number of times pill bottles are opened, responses to Medication Adherence Report Scale (MARS-5) questionnaire, number of pharmacy fills, and mean corpuscular volume (MCV) . | 84 days after completion of enrollment to efficacy phase of study |
| Feasibility of text message interventions to improve adherence to oral chemotherapy (Pilot Phase) | Feasibility will be measured based on participant responses to validated questionnaires - Feasibility of intervention measure (FIM) and Acceptability of intervention measure (AIM). Both forms are 4 items scored on a 5 point Likert scale. Scores greater than or equal to 16 will determine whether the intervention is feasible. | 28 days after completion of enrollment to pilot phase of study |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the relationship between oral chemotherapy adherence and patient factors | At the start of cycle 1, Health Competence Beliefs Inventory (HCBI) scores will be collected as a baseline measurement of self-efficacy as measured in a prior AYA adherence study. Higher HCBI scores and lower ADI and SVM scores will be associated with higher adherence given prior associations with self-efficacy and family finances. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Intake | Contact | 1-855-702-8222 | cancerclinicaltrials@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Austin Wesevich | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medicine Comprehensive Cancer Center | Recruiting | Chicago | Illinois | 60637 | United States |
Study results including PHI such as dates, assigned study ID, and initials may be shared with researchers and their teams at other sites as part of required safety reporting notifications (e.g. serious events/unanticipated problems, or other reportable events). Final reports (no PHI) may also be shared. Names and medical record numbers will not be shared externally.
Data will only be shared for analysis purposes.
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| No Text Messagings | Other | Standard Care |
|
| Low Intensity Text Messaging | Other | Weekly Texts |
|
| 1 year |
| To compare adherence to oral chemotherapy between study groups for second treatment cycle (Efficacy Phase) | Adherence to chemotherapy regimen will be measured based on combined data from 8.1 Medication Event Monitoring System (MEMS) TrackCap devices which measure the number of times pill bottles are opened, responses to Medication Adherence Report Scale (MARS-5) questionnaire, number of pharmacy fills, and mean corpuscular volume (MCV) . | 168 days after completion of enrollment to efficacy phase of study |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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