A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults With Cancer

November 17, 2025 updated by: Children's Hospital Medical Center, Cincinnati
A pilot feasibility randomized clinical trial comparing a tailored intervention to uniform standard of care will be conducted. A total of 40 AYAs with cancer will be randomized to one of the two programs. Data will be collected to explore the hypotheses that the intervention meets pre-established enrollment, retention, fidelity, and data completion feasibility criteria and that AYAs will rate the intervention as easy to use and acceptable.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed research includes a randomized clinical trial of a tailored adherence-promotion intervention (Tailored Program) as compared to uniform standard of care (Feedback Program) for adolescents and young adults with cancer. Up to 40 adolescents and young adults (AYAs) with cancer will be enrolled in this study. Participants who enroll in this trial will be given an eCAP electronic monitor, a pill bottle with a computer chip in the cap, to store their medication. After using the electronic monitor for 4 weeks to assess baseline adherence, participants who demonstrate non-adherence and have used the electronic monitor without difficulty will be asked to complete pre-treatment questionnaires. Next, participants will be randomly assigned to either the tailored adherence-promotion intervention group (Tailored Program) or the uniform standard of care group (Feedback Program). Participants will be assigned in a 1:1 ratio so that, at the end of the study, an equal number of participants will have been randomized to each group.

Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired.

Adolescents and young adults will continue to use the electronic monitor to store their medication until approximately a month after their program ends. After their program ends, participants will complete post-treatment questionnaires regarding program usability and acceptability as well as their adherence.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St Jude Children's Research Hospital
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient between 15 and 24 years of age
  • Patient diagnosis of cancer
  • Patient prescribed oral chemotherapy or prophylactic medication

Exclusion Criteria:

  • Patient is not fluent in English
  • Patient evidences significant cognitive deficits per medical team
  • Patient's medical status or treatment precludes participation per medical team, patient, or caregiver
  • Patient demonstrates greater than or equal to 95% adherence during run-in period
  • Patient declines to use electronic monitoring device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tailored Program
8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins
Behavioral: Tailored Program
Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data.
Other: Feedback Program
8-week feedback program including 8 weekly texts
Behavioral: Feedback Program
Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment Rate
Time Frame: End of study enrollment period, approximately 12 months after enrollment initiation
Percent of approached eligible participants enrolling in the study
End of study enrollment period, approximately 12 months after enrollment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention Rate
Time Frame: From enrollment to study completion (approximately 4 weeks for patients deemed ineligible after run-in and approximately 16 weeks for patients deemed eligible after run-in)
The percent of participants completing all procedures for which they were eligible The numerator is calculated via the following formula: (n AYAs eligible to complete at least some study procedures [n enrolled AYAs - n AYAs meeting criteria for unenrollment prior to study start] - n AYAs who never started study procedures - n AYAs who did not complete at least some study procedures) The denominator (n AYAs eligible to complete at least some study procedures) is calculated via the following formula: (n enrolled AYAs - n AYAs meeting criteria for unenrollment prior to study start)
From enrollment to study completion (approximately 4 weeks for patients deemed ineligible after run-in and approximately 16 weeks for patients deemed eligible after run-in)
Intervention Fidelity: Contact
Time Frame: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Percent of participants randomized to the Tailored Program who completed 4 intervention sessions
From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Intervention Fidelity: Length
Time Frame: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Percent of participants randomized to the Tailored Program for whom all sessions were 30-45 minutes in length
From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Intervention Fidelity: Duration
Time Frame: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Percent of randomized to the Tailored Program who completed all 4 intervention sessions during a 8-10 week period
From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Intervention Fidelity: Content
Time Frame: From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Percent of participants randomized to the Tailored Program who received all of the planned intervention content as defined in the fidelity checklist
From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks)
Assessment Completion
Time Frame: From enrollment to the completion of post-intervention assessment which occurred approximately 4 weeks after program completion (total time frame = approximately 16 weeks)
Percent of enrolled participants with complete data
From enrollment to the completion of post-intervention assessment which occurred approximately 4 weeks after program completion (total time frame = approximately 16 weeks)
System Usability Scale
Time Frame: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
A 10-item rating of usability, range = 0-100, better scores indicate better usability
Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
"Adjective Rating Scale" (Measure of Usability)
Time Frame: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
1-item rating of user friendliness, range = 1 (worst imaginable) to 7 (best imaginable), higher scores indicate better usability
Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
Number of Participants Rating Behavioral Treatment Acceptability as 4 or Greater
Time Frame: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
Rating of behavioral treatment acceptability - "I would recommend this program to other adolescents and young adults"; Possible range = 1 (strongly disagree) - 5 (strongly agree), better scores represent better acceptability; Dichotomous variable created representing whether participants scored this item as 1-3 (not acceptable) or 4-5 (acceptable)
Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
Medical Adherence Measure
Time Frame: Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
1-item self-report of missed doses
Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment
Electronically Monitored Medication Adherence
Time Frame: Starting 4 weeks prior to treatment initiation (approximately weeks 1-4) and continuing until 4 weeks after program completion (approximately weeks 12-16)
Each participant will be given an electronic monitoring device to store their medication. The electronic monitoring device records each time the device is opened.
Starting 4 weeks prior to treatment initiation (approximately weeks 1-4) and continuing until 4 weeks after program completion (approximately weeks 12-16)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Seattle Children's Hospital
St. Jude Children's Research Hospital
University of Cincinnati

Investigators

  • Principal Investigator: Meghan E McGrady, PhD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2023

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 31, 2023

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21CA268945 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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