An Intervention to Promote Oral Agent Adherence and Symptom Management: ADHERE

Purpose/Aims: Over 50 oral agents in pill form are currently on the market, with projections
that in three years, 25% of cancer treatment will be delivered in pill form with patients
assuming responsibility for self-management at home. For oral agents to achieve a
therapeutically effective level for cancer treatment, patients must strictly adhere to the
regimen. Adherence to oral cancer agents is often less than 80%, which may be inadequate for
treating the cancer. The aim of this study is to refine and determine the feasibility and
preliminary efficacy of an intervention (entitled "ADHERE") that uses motivational
interviewing (MI) to elicit reasons to adhere and brief cognitive behavioral therapy (CBT)
as a mechanism for goal-oriented systematic patient education (PE) to promote adherence and
symptom management among cancer patients prescribed oral agents. Significance: This study
targets a challenging clinical problem among patients with a life-threatening disease,
assisting them in adhering to and completing their cancer treatment, impacting symptoms,
quality of life, and longevity. Framework: The Motivation and Behavior Skills Model guides
this work. The model asserts even a well informed or highly motivated patient will have
difficulty achieving and sustaining optimal adherence if they lack the skills required to
acquire or self-manage or feel incapable of performing such behaviors. Main Variables:
Adherence and symptom severity. Methods: This practice-based study will be conducted using a
4-week intervention (ADHERE) to promote adherence and symptom management in patients newly
prescribed oral agents in two phases. Phase 1 will use a single-subject-design to
consecutively enrolling 5-patients from a cancer center over 4-weeks and investigators will
use an iterative process to refine ADHERE in a practice-based setting. Phase 2 will use an
8-week quasi-experimental sequential design, enrolling 60-patients (30 intervention & 30
control) from 2-cancer centers to examine feasibility and preliminary efficacy of a 4-week
ADHERE intervention and follow-up for 4-weeks to assess adherence and symptom management.
Descriptive statistics will be provided as appropriate for all data collected, and 95%
confidence intervals will be provided by using exact method for outcome variables, such as:
the proportion of patients who are enrolled to participate in the study among those who are
recruited; the proportion of ADHERE received by the patient over the four-week time period;
and the proportion of patients who report high satisfaction with ADHERE. Exploratory
analysis of efficacy as measured weekly by proportion of pills taken compared to what was
prescribed. Implications: This study has the potential to have a transformative impact on
oral agent adherence by developing an advanced practice registered nurse-led strategy to
promote adherence among the increasing number of cancer patients who receive their cancer
treatment in pill form. This intervention will lead to standardized care for patients newly
prescribed oral agents. Results of this study will be used to inform the development of an
R01 application to conduct a larger randomized trial to test the efficacy of this innovative
intervention.

Inclusion Criteria:

- Diagnosed with cancer

- Newly prescribed (within 60-days) an oral anti-cancer agent

- Have a phone and be willing and able to receive phone calls

- Able to read, speak, and understand English

- Cognitively intact and able to self-manage and follow direction, as evaluated by the
Recruiter

Exclusion Criteria:

- Unable to accept phone calls