Grant Number:	5R21CA268945-02 Interpret this number
Primary Investigator:	Mcgrady, Meghan
Organization:	Cincinnati Childrens Hosp Med Ctr
Project Title:	A Pilot Feasibility Trial of a Tailored Intervention to Improve Adherence in Adolescents and Young Adults with Cancer
Fiscal Year:	2024

PROJECT SUMMARY/ABSTRACT Up to 60% of adolescents and young adults (AYAs) with cancer are non-adherent to cancer treatment medications and thus at an increased risk of relapse and death. In response, multiple professional organizations have endorsed medication adherence promotion as a standard of pediatric cancer care and a critical component of AYA oncology programs. Improving adherence, however, has proved difficult as barriers to adherence differ across AYAs and each barrier requires a different set of behavior change techniques (BCTs). Despite this need for tailoring, the two adherence-promotion interventions including AYAs with cancer to date have taken a “one-size-fits-all” approach and produced non-significant or small treatment effects. This leaves a critical gap between the recommended standards of care and available interventions to improve adherence. The proposed research hypothesizes that delivering an intervention in which BCTs are tailored to address a given AYA’s top barriers may hold promise for improving adherence among AYAs with cancer. Directly aligned with PAR-19-309’s call for “novel strategies to improve cancer-related health behaviors [i.e., adherence],” the purpose of the proposed research is to conduct a pilot feasibility test of a tailored adherence-promotion intervention for AYAs with cancer. The proposed research also directly responds to the National Cancer Institute’s current special interest in grants that “test innovative interventions...to optimize patient treatment regimen adherence” (NOT-CA-20-026). A pilot feasibility randomized clinical trial comparing this tailored intervention to uniform standard of care will be conducted. A total of 40 AYAs with cancer from 3 sites will be randomized to the tailored adherence-promotion intervention or uniform standard of care. 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. Exploratory analyses will be conducted to evaluate potential group differences in electronically-monitored medication adherence. Findings will be used to inform subsequent phases of intervention development and testing.




Feasibility pilot trial of a tailored medication adherence-promotion intervention for adolescents and young adults with cancer: Study design and protocol.
Authors: McGrady M.E. , Ketterl T.G. , Webster R.T. , Schwartz L.E. , Brock M.Y. , Szulczewski L. , Burke M. , Hommel K.A. , Pai A.L.H. , Mara C.A. , et al. .
Source: Contemporary clinical trials, 2024 Apr; 139, p. 107483.
EPub date: 2024-02-29.
PMID: 38431133
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