The AYA Oncology Self-care Movement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-25
SponsorNorthwestern University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Cognitive impairments that would limit ability to complete measures, determined by the medical team
Absence of inclusion criteria above.
Trial design
Design model
Parallel
Treatments tested in this trial
Educational Website
BehavioralWebsite providing basic information about 6-mercaptopurine (e.g., type, what it is used for, strategies for remembering to take it)
#AYAOSM
BehavioralSocial 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".
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: #AYAOSMExperimental treatment 2 interventions
Group B: Educational Website OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Electronically-monitored Medication Adherence
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.
Time frame
6-monthsSecondary outcomes
1
Medication Adherence Measure (4 items)
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.
Time frame
6-months2
PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment - Short Form (8 items)
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.
Time frame
6-months3
Theory of Planned Behavior Questionnaire (3 items)
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.
Time frame
6-months4
PROMIS Emotional Support and Information Support - Short Forms (8 items each)
PROMIS® Emotional Support and Information Support Short Forms (8 items each). Higher scores indicate greater perceived emotional support and information support.
Time frame
6-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: