Newer oral anti-cancer medications, specifically molecularly targeted tyrosine kinase inhibitors (TKIs) medications have improved the overall prognosis of patients with cancer. When properly adhered to, these medications can extend progression-free survival by several years. Despite the promise of TKIs, nonadherence is problematic and poor adherence is of significance as it is associated with disease progression and mortality. Despite the importance of optimal adherence (90% for TKIs), only a handful of interventions have included on adherence to the newer molecularly targeted TKI oral medications. Patients taking TKIs have fewer opportunities to be directly observed in clinic, therefore the burden of accurate medication administration and compliance rests with patients at home, presenting a challenge to medication adherence and symptom and toxicity monitoring. Strategies that (a) facilitate patient-provider communication about side effects and symptom monitoring, and (b) incorporate evidence-based tools to improve symptom monitoring and management, uncertainty tolerance and coping with illness-related stress may be specially beneficial to aiding cancer patients optimally adhere to these medications. We propose that an evidence-based psychosocial intervention that can improve management of oral anticancer medication side effects and improve health-related quality of life in cancer patients may also improve medication adherence. Consistent with PA-17-061, we propose to establish the feasibility of an evidence-based, web-based and adaptive program called OncoMed to improve adherence to TKIs. OncoMed is grounded in models of health behavior change, self-management and established barriers (e.g., patient factors, system/provider factors, treatment factors) of medication adherence. OncoMed will incorporate patient education (e.g., compliance education, medication adherence benefits), weekly medication side effect tracking and linking of patient-reported side effects to oncology providers as well as medical and psychosocial management strategies for managing medication side effects.
Our specific aims are as follows: (a) to develop OncoMed, a scalable and adaptive web-based platform that will improve adherence to oral TKI medications and conduct usability testing with a sample of cancer patients (n=10) to refine and finalize this novel web-based platform and, (b) to establish the feasibility of OncoMed by implementing our study procedures (recruitment, assessment) and study conditions (OncoMed+usual care vs. health education [HE]+usual care control). Patients (n = 80) will be randomized to the conditions. We propose to implement well-established and recommended procedures for assessing feasibility, which include documenting acceptability (e.g., satisfaction), demand (e.g., recruitment, retention), practicality (e.g., self-efficacy, patient-provider communication), and preliminary efficacy of our intervention We hypothesize that both conditions will be feasible but that the OncoMed + usual care condition will have better preliminary efficacy outcomes than the HE + usual care control condition.

Public Health Relevance

Newer oral anti-cancer medications, specifically molecularly targeted tyrosine kinase inhibitors (TKIs) medications have improved the overall prognosis of patients with cancer. Despite the promise of TKIs, nonadherence is problematic and is associated with disease progression and mortality. We propose that an evidence-based psychosocial intervention that can improve management of oral anticancer medication side effects and improve HRQoL in cancer patients may also improve medication adherence.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21CA226671-01A1
Application #
9600003
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Chou, Wen-Ying
Project Start
2018-08-01
Project End
2020-07-31
Budget Start
2018-08-01
Budget End
2019-07-31
Support Year
1
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Northwestern University at Chicago
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
005436803
City
Chicago
State
IL
Country
United States
Zip Code
60611