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出境医 / 临床实验 / Mobile Health Intervention to Support Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia

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

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Behavioral: AYA ADAPTS (ADherence Assessments and Personalized Timely Support). Not Applicable

Detailed 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 AYA ADAPTS (ADherence Assessments and Personalized Timely Support). AYA 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 MEMS TrackCaps 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.

AYA 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, MEMS TrackCaps will be returned and downloaded during the clinic appointment. AYA will complete a brief acceptability survey electronically via REDCAP, rating AYA 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, MEMS, post-measures).

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a 28-day micro-randomized pilot trial (i.e., a sequential factorial design) of a just-in-time adaptive intervention called AYA ADAPTS (Adherence Assessments and Personalized Timely Support). AYA ADAPTS is an app that will deliver contextually-tailored mobile messages (adapted to AYA's current states, such as mood, pain, and location) designed to promote oral chemotherapy adherence. Each AYA in the study (n=30) will be micro-randomized (with a 60% probability) to receive a contextually-tailored message each day that supports abilities to self-manage and maintain adherence, delivered prior to their scheduled dose, over a 28-day period (i.e., the period between follow-up appointments). The remaining 40% of days, participants will be assigned to receive no messages (i.e., no intervention).
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Using Real Time Mobile Health Approaches to Understand and Promote Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : June 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: Contextually-tailored Mobile Messages for Adherence
All participants will be micro-randomized to receive contextually-tailored mobile messages designed to promote their oral chemotherapy adherence, with a 60% probability of receiving a contextually-tailored message each day.
 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.
No Intervention: No messages
All participants will also be micro-randomized to not receive messages on some days of the intervention (~40% of the time).
Outcome Measures
Primary Outcome Measures :
  1. Screening Rate [ Time Frame: Up to 12 months ]
    Number of AYA patients referred and screened per month

  2. Recruitment Rate [ Time Frame: Up to 12 months ]
    Number of AYA patients enrolled in the study per month

  3. Retention Rate [ Time Frame: Up to 12 months ]
    Number of AYA subjects who complete the intervention, out of the total number of AYA subjects enrolled in the study

  4. Intervention Engagement [ Time Frame: 28-day intervention period ]
    Number of acknowledged micro-randomized text messages; categorized by "thumbs up", "thumbs down", and "snooze" responses

  5. Technical Difficulties [ Time Frame: 28-day intervention period ]
    Number of technical glitches and errors experienced in implementing the intervention

  6. Intervention Satisfaction [ Time Frame: At completion of 28-day intervention ]
    5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)

  7. Intervention Perceived Appropriateness [ Time Frame: At completion of 28-day intervention ]
    5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)

  8. Intervention Perceived Positive Effects [ Time Frame: At completion of 28-day intervention ]
    5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)

  9. Intervention Perceived Demands [ Time Frame: At completion of 28-day intervention ]
    5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)

  10. Potential for Intervention Future Use [ Time Frame: At completion of 28-day intervention ]
    5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 15-25
  • Diagnosed with acute lymphoblastic leukemia (ALL)
  • In the maintenance phase, completed at least one cycle and has at least one month of maintenance therapy remaining
  • Prescribed 6-mercaptopurine (6MP)
  • Self-reported 6MP adherence <95% in the past month
  • 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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Alexandra M Psihogios, Ph.D. 267-314-0164 psihogiosa@chop.edu

Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Layout table for investigator information
Principal Investigator: Alexandra M Psihogios, Ph.D. Children's Hospital of Philadelphia
Study Chair: Lamia P Barakat, Ph.D. Children's Hospital of Philadelphia
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date May 17, 2021
Estimated Study Start Date  ICMJE July 2022
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • Screening Rate [ Time Frame: Up to 12 months ]
    Number of AYA patients referred and screened per month
  • Recruitment Rate [ Time Frame: Up to 12 months ]
    Number of AYA patients enrolled in the study per month
  • Retention Rate [ Time Frame: Up to 12 months ]
    Number of AYA subjects who complete the intervention, out of the total number of AYA subjects enrolled in the study
  • Intervention Engagement [ Time Frame: 28-day intervention period ]
    Number of acknowledged micro-randomized text messages; categorized by "thumbs up", "thumbs down", and "snooze" responses
  • Technical Difficulties [ Time Frame: 28-day intervention period ]
    Number of technical glitches and errors experienced in implementing the intervention
  • Intervention Satisfaction [ Time Frame: At completion of 28-day intervention ]
    5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)
  • Intervention Perceived Appropriateness [ Time Frame: At completion of 28-day intervention ]
    5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)
  • Intervention Perceived Positive Effects [ Time Frame: At completion of 28-day intervention ]
    5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)
  • Intervention Perceived Demands [ Time Frame: At completion of 28-day intervention ]
    5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)
  • Potential for Intervention Future Use [ Time Frame: At completion of 28-day intervention ]
    5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mobile Health Intervention to Support Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia
Official Title  ICMJE Using Real Time Mobile Health Approaches to Understand and Promote Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia
Brief 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.
Detailed 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 AYA ADAPTS (ADherence Assessments and Personalized Timely Support). AYA 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 MEMS TrackCaps 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.

AYA 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, MEMS TrackCaps will be returned and downloaded during the clinic appointment. AYA will complete a brief acceptability survey electronically via REDCAP, rating AYA 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, MEMS, post-measures).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a 28-day micro-randomized pilot trial (i.e., a sequential factorial design) of a just-in-time adaptive intervention called AYA ADAPTS (Adherence Assessments and Personalized Timely Support). AYA ADAPTS is an app that will deliver contextually-tailored mobile messages (adapted to AYA's current states, such as mood, pain, and location) designed to promote oral chemotherapy adherence. Each AYA in the study (n=30) will be micro-randomized (with a 60% probability) to receive a contextually-tailored message each day that supports abilities to self-manage and maintain adherence, delivered prior to their scheduled dose, over a 28-day period (i.e., the period between follow-up appointments). The remaining 40% of days, participants will be assigned to receive no messages (i.e., no intervention).
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Acute Lymphoblastic Leukemia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Contextually-tailored Mobile Messages for Adherence
    All participants will be micro-randomized to receive contextually-tailored mobile messages designed to promote their oral chemotherapy adherence, with a 60% probability of receiving a contextually-tailored message each day.
    Intervention: Behavioral: AYA ADAPTS (ADherence Assessments and Personalized Timely Support).
  • No Intervention: No messages
    All participants will also be micro-randomized to not receive messages on some days of the intervention (~40% of the time).
Publications *
  • 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.
  • 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.
  • 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:1220-8. doi: 10.1037/hea0000305.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages 15-25
  • Diagnosed with acute lymphoblastic leukemia (ALL)
  • In the maintenance phase, completed at least one cycle and has at least one month of maintenance therapy remaining
  • Prescribed 6-mercaptopurine (6MP)
  • Self-reported 6MP adherence <95% in the past month
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexandra M Psihogios, Ph.D. 267-314-0164 psihogiosa@chop.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03932903
Other Study ID Numbers  ICMJE 19-016325
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexandra M Psihogios, Ph.D. Children's Hospital of Philadelphia
Study Chair: Lamia P Barakat, Ph.D. Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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