Acute Lymphobkastic Leukemia, Medication Adherence
Conditions
Keywords
Adolescents and young adults, cancer, medication adherence, social media, oral chemotherapy, digital health, leukemia
Brief summary
This trial will test the impact of a social media intervention for improving oral chemotherapy adherence among adolescents and young adults (AYAs) with acute lymphoblastic leukemia.
Detailed description
For adolescents and young adults (AYAs) who meet inclusion criteria, trained staff will introduce the study and confirm eligibility using a standardized checklist. For AYAs \<18 years old, we will conduct enrollment with AYAs and their parent/legal guardian together, as we have successfully done before. After study procedures are thoroughly explained and questions are answered, informed written eConsent and eAssent (AYAs \<18) will be obtained. Across aims, AYAs will then complete a baseline questionnaire (assessing demographics, cancer information, and perceived medication adherence and self-management abilities). Electronic health record (EHR) review will also occur, with release forms obtained for AYAs outside our centers. Trial data collection will occur over 6-months. All enrolled AYAs will complete baseline (T1) measures (\ 20 minutes) online via REDCap. All enrolled participants will be provided with and receive a tutorial on a validated electronic adherence monitor, which they will be instructed to use to monitor daily 6-MP adherence for the entire 6-month study period. For 28-days (i.e., the typical time between follow-up visits), all enrolled AYAs (both groups) will complete a run-in period involving electronic monitoring of 6-MP adherence only (no intervention) to calculate baseline adherence rates. On day 29, AYAs will complete a checklist about their usage of the electronic pill bottle (to problem-solve any barriers prior to randomization) and then be randomized to the #AYAOSM social media intervention or no message control. Participants in both groups will be asked to continue using the electronic pill bottle to passively monitor 6-MP adherence over the next five months. Participants in both groups will also be provided with an educational website describing basic information about 6-MP. #AYAOSM Intervention Group. For AYAs randomized to the social media condition, the intervention will begin on day 29 and last for 12 weeks. Across the 12-week intervention period, AYAs will receive \ 2-3 distinct social media messages per week. Messages will be delivered using direct messaging to the participant's own social media account (e.g., TikTok or Instagram), from a study-created social media account. Control Condition. AYAs who are randomized to the control will only receive the educational website and continue to monitor their 6-MP adherence electronically. They will not receive any of the social media messages during the 6-month period. Following the intervention period, all participants will be asked to complete follow-up REDCap surveys of self-management variables at 4-months (T2) and 6-months (T3). In addition to self-management indices, AYAs from the social media group will complete a questionnaire measure of intervention acceptability at T2. Some AYAs will also be asked to complete an interview about their experiences with the intervention. Electronic pill bottles will be returned to the study team to download data at T3.
Interventions
BEHAVIORALEducational Website
Website providing basic information about 6-mercaptopurine (e.g., type, what it is used for, strategies for remembering to take it)
BEHAVIORAL#AYAOSM
Social media messages (videos/images) that target medication self-management skills/knowledge, self-efficacy, and social support. Messages were created in collaboration with young adult cancer survivors who are also prominent content creators or "influencers".
Sponsors
Northwestern University
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* 15-25 years old * Diagnosed with acute lymphoblastic leukemia (ALL) * Taking 6-mercpatopurine (6-MP) as part of their maintenance treatment with at least 6-months remaining * Be able to speak and read English * Have at least one active social media account (e.g., Instagram, TikTok) or be willing to download a platform for the study * Endorse missing a 6-MP dose in the prior month and/or at least one adherence barrier.
Exclusion criteria
* Cognitive impairments that would limit ability to complete measures, determined by the medical team * Absence of inclusion criteria above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electronically-monitored Medication Adherence | 6-months | 6-mercaptopurine (6-MP) adherence will be assessed using a Medication Event Monitoring System (MEMS), an electronic pill bottle cap that records bottle openings with date and time stamps. Adherence will be calculated as the percentage of prescribed days with a recorded bottle opening (number of days with openings/number of prescribed days × 100). The primary analysis will evaluate the proportion of participants achieving the clinically meaningful threshold of ≥95% adherent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence Measure (4 items) | 6-months | Medication knowledge will be assessed by evaluating participants' knowledge of 1) medication name, 2) dosing frequency, 3) dose amount, and 4) medication purpose. Participant responses will be compared with the prescribed medication regimen documented in the electronic health record. Scores range from 0 to 4, with higher scores indicating greater medication knowledge. |
| PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment - Short Form (8 items) | 6-months | A validated, patient-reported instrument designed to assess an individual's confidence in their ability to successfully perform specific tasks or behaviors related to managing a long-term medical health condition. Items are rated on a Likert scale and scored using the PROMIS scoring system, with higher T-scores indicating greater self-efficacy for managing medications and treatment. |
| Theory of Planned Behavior Questionnaire (3 items) | 6-months | Three adapted items from the Theory of Planned Behavior Questionnaire assessing descriptive norms, injunctive norms, and identification with the referent group. Responses are measured on a 7-point Likert scale, with higher scores indicating stronger endorsement of each construct. |
| PROMIS Emotional Support and Information Support - Short Forms (8 items each) | 6-months | PROMIS® Emotional Support and Information Support Short Forms (8 items each). Higher scores indicate greater perceived emotional support and information support. |
| Objective engagement with social media intervention | 12-week intervention period | Objective engagement with private social media messages will be assessed among participants in the intervention group using platform analytics. Measures include the percentage of messages viewed, the percentage of messages liked, and the number of text responses. Text responses will be qualitatively coded to characterize participant engagement. |
| Implementation barriers and facilitators | 6-months | Semi-structured interview guides, tailored to each stakeholder group, will be informed by the updated Consolidated Framework for Implementation Research (CFIR). Following presentation of representative social media intervention messages, participants will be asked about perceived implementation barriers and facilitators related to the intervention, including characteristics of the innovation (e.g., design, credibility, relative advantage), individual factors (e.g., capability, opportunity, motivation), inner setting (e.g., mission alignment, compatibility, infrastructure), and outer setting (e.g., policies, partnerships, and societal influences). |
Countries
United States
Contacts
CONTACTAlexandra Psihogios, Ph.D.
Outcome results
None listed