NCT05706610

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

February 23, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
8 months until next milestone

Results Posted

Study results publicly available

December 2, 2025

Completed
Last Updated

December 2, 2025

Status Verified

October 1, 2025

Enrollment Period

1.8 years

First QC Date

January 11, 2023

Results QC Date

October 21, 2025

Last Update Submit

November 17, 2025

Conditions

CancerAdherence, Medication

Keywords

canceradherence

Outcome Measures

Primary Outcomes (1)

  • Enrollment Rate

    Percent of approached eligible participants enrolling in the study

    End of study enrollment period, approximately 12 months after enrollment initiation

Secondary Outcomes (11)

  • Retention Rate

    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

    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

    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

    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

    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)

  • +6 more secondary outcomes

Study Arms (2)

Tailored Program

EXPERIMENTAL

8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins

Behavioral: Tailored Program

Feedback Program

OTHER

8-week feedback program including 8 weekly texts

Behavioral: Feedback Program

Interventions

Tailored ProgramBEHAVIORAL

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.

Tailored Program
Feedback ProgramBEHAVIORAL

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.

Feedback Program

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

St Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (2)

  • McGrady ME, Ketterl TG, Webster RT, Burns MMK, Bills SE, Burke M, Szulczewski L, Brock MY, Schwartz LE, Herriott JK, Hommel KA, Pai ALH, Mara CA, Norris RE. Feasibility Trial of a Tailored Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer. Pediatr Blood Cancer. 2026 Jan;73(1):e32127. doi: 10.1002/pbc.32127. Epub 2025 Oct 27.

    PMID: 41146444DERIVED

  • McGrady ME, Ketterl TG, Webster RT, Schwartz LE, Brock MY, Szulczewski L, Burke M, Hommel KA, Pai ALH, Mara CA, Steele AC, Regan GG, Norris RE. Feasibility pilot trial of a tailored medication adherence-promotion intervention for adolescents and young adults with cancer: Study design and protocol. Contemp Clin Trials. 2024 Apr;139:107483. doi: 10.1016/j.cct.2024.107483. Epub 2024 Feb 29.

    PMID: 38431133DERIVED

MeSH Terms

Conditions

NeoplasmsMedication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr. Meghan McGrady
Organization
Cincinnati Children's Hospital Medical Center
meghan.mcgrady@cchmc.org
513-803-8044

Study Officials

  • Meghan E McGrady, PhD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 31, 2023

Study Start

February 23, 2023

Primary Completion

November 30, 2024

Study Completion

March 31, 2025

Last Updated

December 2, 2025

Results First Posted

December 2, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)