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Completed

NCT Number: NCT05706610

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

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.

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Key information

Conditions

Cancer Adherence, Medication Behavior Health Behavior Medication Adherence Neoplasms Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

15 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored Program

Behavioral

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.

Feedback Program

Behavioral

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.

Primary outcomes

  1. Enrollment Rate

    Time frame: End of study enrollment period, approximately 12 months after enrollment initiation

    Percent of approached eligible participants enrolling in the study

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. "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

  9. 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)

  10. 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

  11. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

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

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 31, 2023
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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