Trial Information

Text Messaging to Improve Adherence to Oral Chemotherapy Agents

The therapeutic outcome of cancer treatment for patients taking oral chemotherapy agents
depends heavily on adherence to the oral agent regimen. Yet recent research indicated that
patients miss one-third of oral chemotherapy agent doses. With more than 50 oral anti-cancer
agents on the market, it is projected that within 3 years, 25% of cancer treatment will be
delivered in pill form. In this new treatment paradigm, care is moved from the clinics to
home settings. This means that patients are seen less frequently by oncologists and greater
responsibility is placed on the patients. Complicating this further, 75% of those with
cancer also have comorbid conditions that require them to perform other self-care management
(SCM) responsibilities. In addition, many have low self-efficacy, which may interfere with
their ability to adhere to the oral agent. The therapeutic outcome for patients taking oral
agents depends heavily on engaging patients to adhere to the regimen. Thus, a critical need
exists to test novel interventions that promote adherence in patients taking oral
chemotherapy agents.

The long-term goal of this research is to develop novel interventions to improve
bio-behavioral outcomes of patients with cancer who have treatment in pill form. The
objective of this study is to determine the feasibility, acceptability, satisfaction and
efficacy of a short message service (SMS) text message intervention to promote adherence
among cancer patients prescribed oral agents. The strategy to achieve this objective is to
examine how technology can be used to improve adherence and to explore translation of these
technologies to the clinical setting by deploying the following research plan.

This 10-week, 2-group, prospective randomized controlled trial will enroll 75 patients (50
in the intervention group and 25 in the control group), from 2 cancer centers, to test the
feasibility and efficacy of a tailored intervention using text messages delivered to
patient's cell phones to promote oral agent adherence. As these patients are newly
prescribed an oral agent, they will be randomly assigned to either the intervention or the
control group. At baseline (week 1), we will assess age, sex, race, cancer type and stage,
self-efficacy, comorbid conditions and their SCM, and symptoms. For 21 days (week 2-4) the
intervention group will receive a tailored text message for oral agent adherence plus usual
care and the control group will receive only usual care. Each week (week 2-9) and at exit
(week 10) an assessment of oral agent adherence and symptoms will occur. Satisfaction with
the intervention will also be evaluated during the exit interview.

Specific Aims

Aim #1. To determine feasibility, defined as patient acceptance, retention in the study, and
satisfaction, of a tailored text message intervention among patients who are on oral agents.
Hypotheses to be tested are:

Hypothesis 1a: 80% of participants recruited will enroll in the study.

Hypothesis 1b: 80% of patients in the intervention group will complete 21 days of tailored
text messages.

Hypothesis 1c: 90% of the intervention group will be satisfied with the tailored text
messages.

Aim #2. To determine preliminary efficacy of the tailored text message intervention on
adherence to oral agents. Hypotheses to be tested are:

Hypothesis 2a: The intervention group will have significantly higher rates of oral agent
adherence than the control group.

Hypothesis 2b: There will be a large effect size of the intervention for group differences
in adherence rates.

Exploratory aim: To explore the effect of oral agent complexity, low self-efficacy, symptom
severity, comorbid conditions, and SCM of comorbid conditions on adherence to oral agents.
We expect that adherence will be greater for patients with higher self-efficacy, simple oral
agents, for those with fewer comorbid conditions, for those with fewer SCM responsibilities
for their comorbid conditions, and for those with lower symptom severity.

This study can have a transformative impact on oral agent adherence by developing an
easy-to-use, technology-based intervention to promote adherence among the increasing number
of cancer patients whom receive treatment in this manner.

The significance of this study is that it targets a difficult clinical problem among
patients who are very sick with a life threatening disease and must adhere to complex
treatment protocols. This innovative intervention involves a readily available technology
that can be used to interact with patients on a regular, consistent basis that would
otherwise not be possible, feasible, or cost effective if done in a one-by-one interaction
with a health care provider. The number of cancer patients who receive chemotherapy in pill
form is increasing and this intervention will enable them to adhere and complete their
cancer treatment. Thus, the intervention has high generalizability and the potential to
transform care.