Mobile Health Intervention to Support Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Using Real Time Mobile Health Approaches to Understand and Promote Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03932903
• Other study ID #: 19-016325
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: Northwestern University
• Contact: Alexandra M Psihogios, Ph.D.
• Phone: 240-994-6546
• Email: alex.psihogios[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a small-scale micro-randomized clinical trial of a new mobile just-in-time adaptive intervention (JITAI) designed to promote oral chemotherapy adherence in adolescents and young adults (AYA) with acute lymphoblastic leukemia (ALL). The goals of this study are to determine intervention feasibility and acceptability.

Description:

This is a 28-day micro-randomized pilot trial (i.e., a sequential factorial design) of a just-in-time adaptive intervention (JITAI) called ADAPTS (ADherence Assessments and Personalized Timely Support). ADAPTS is an app that integrate contextually-tailored mobile messages designed to promote oral chemotherapy adherence. Participants in the study will electronically-monitor 6MP adherence with eCAPs and complete short ecological momentary assessment (EMA) surveys each afternoon, at the same time prior to the evening 6MP dose, for the 28-day period.

ADAPTS will deliver contextually-tailored text messages triggered based on EMA responses (e.g., based on fatigue, mood) and objective data (e.g., time of day, weekend vs. weekday). After receiving a contextually-tailored message, AYA will be asked to acknowledge receipt of the message by pressing a "thumbs up" or "thumbs down" button, to indicate whether or not they liked the message, or a "snooze" button indicating that it was not a good time to receive the message.

Following the 28-day intervention period, eCAPS will be returned and downloaded during the clinic appointment. AYA will complete a brief acceptability survey electronically via REDCAP, rating ADAPTS on a 5-point Likert scale to assess satisfaction, perceived appropriateness, perceive positive effects, perceived demands, and potential for future use. Exit interviews will also be conducted, audio-recorded, and transcribed to further assess acceptability. For feasibility, the following variables will be tracked: (1) screening rates, (2) recruitment rates, (3) % acknowledged micro-randomized messages, (4) technical difficulties (e.g., micro-randomized messages received when intended), (5) retention rates, and (6) completed assessments (EMA, eCAPS, post-measures).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 29 Years

Eligibility

Inclusion Criteria:

• Ages 14-29

• Diagnosed with acute lymphoblastic leukemia (ALL) or lymphoma

• In the maintenance phase, completed at least one cycle and has at least one month of maintenance therapy remaining

• Prescribed 6-mercaptopurine (6MP)

• English language proficiency

• For AYA <18, must have informed consent from their caregiver.

Exclusion Criteria:

• Cognitive impairments that would limit ability to complete measures, determined by the medical team

• Absence of inclusion criteria above.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Behavioral:
• AYA ADAPTS (ADherence Assessments and Personalized Timely Support).
AYA ADAPTS is a mobile app intervention that integrates contextually-tailored mobile messages and decision rules about when to deliver the messages, with the ultimate goal of improving oral chemotherapy adherence in adolescents and young adults with acute lymphoblastic leukemia. Each participant will be micro-randomized to receive messages on some days that are adapted to their current characteristics (e.g., mood, pain, location) and designed to promote adherence, and no messages (no intervention) on other days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

References & Publications (8)

Bhatia S, Landier W, Hageman L, Kim H, Chen Y, Crews KR, Evans WE, Bostrom B, Casillas J, Dickens DS, Maloney KW, Neglia JP, Ravindranath Y, Ritchey AK, Wong FL, Relling MV. 6MP adherence in a multiracial cohort of children with acute lymphoblastic leukemia: a Children's Oncology Group study. Blood. 2014 Oct 9;124(15):2345-53. doi: 10.1182/blood-2014-01-552166. Epub 2014 May 14. — View Citation

Butow P, Palmer S, Pai A, Goodenough B, Luckett T, King M. Review of adherence-related issues in adolescents and young adults with cancer. J Clin Oncol. 2010 Nov 10;28(32):4800-9. doi: 10.1200/JCO.2009.22.2802. Epub 2010 Mar 8. — View Citation

Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305. — View Citation

McGrady ME, Brown GA, Pai AL. Medication adherence decision-making among adolescents and young adults with cancer. Eur J Oncol Nurs. 2016 Feb;20:207-14. doi: 10.1016/j.ejon.2015.08.007. Epub 2015 Sep 12. — View Citation

Modi AC, Pai AL, Hommel KA, Hood KK, Cortina S, Hilliard ME, Guilfoyle SM, Gray WN, Drotar D. Pediatric self-management: a framework for research, practice, and policy. Pediatrics. 2012 Feb;129(2):e473-85. doi: 10.1542/peds.2011-1635. Epub 2012 Jan 4. — View Citation

Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8. — View Citation

Psihogios AM, Fellmeth H, Schwartz LA, Barakat LP. Family Functioning and Medical Adherence Across Children and Adolescents With Chronic Health Conditions: A Meta-Analysis. J Pediatr Psychol. 2019 Jan 1;44(1):84-97. doi: 10.1093/jpepsy/jsy044. — View Citation

Psihogios AM, Li Y, Butler E, Hamilton J, Daniel LC, Barakat LP, Bonafide CP, Schwartz LA. Text Message Responsivity in a 2-Way Short Message Service Pilot Intervention With Adolescent and Young Adult Survivors of Cancer. JMIR Mhealth Uhealth. 2019 Apr 18;7(4):e12547. doi: 10.2196/12547. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening Rate	Number of AYA patients referred and screened per month	Up to 12 months
Primary	Recruitment Rate	Number of AYA patients enrolled in the study per month	Up to 12 months
Primary	Retention Rate	Number of AYA subjects who complete the intervention, out of the total number of AYA subjects enrolled in the study	Up to 12 months
Primary	Intervention Engagement	Number of acknowledged micro-randomized text messages; categorized by "thumbs up", "thumbs down", and "snooze" responses	28-day intervention period
Primary	Technical Difficulties	Number of technical glitches and errors experienced in implementing the intervention	28-day intervention period
Primary	Intervention Satisfaction	5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)	At completion of 28-day intervention
Primary	Intervention Perceived Appropriateness	5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)	At completion of 28-day intervention
Primary	Intervention Perceived Positive Effects	5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)	At completion of 28-day intervention
Primary	Intervention Perceived Demands	5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)	At completion of 28-day intervention
Primary	Potential for Intervention Future Use	5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)	At completion of 28-day intervention