Mobile Application for Improving Symptoms and Adherence to Oral Chemotherapy in Patients With Cancer

Background: Over the last decade, novel targeted agents have revolutionized the delivery of
cancer care and improved survival rates, especially in those with metastatic disease. While
oral chemotherapies possess significant advantages with respect to ease of administration,
patients and caregivers receive less support for adherence and monitoring of side effects.
Therefore, novel interventions are essential to help patients communicate in a more open and
timely manner with their oncology clinicians to support adherence. As part of Phase 1 for
this Patient-Centered Outcomes Research Institute (PCORI) grant, we conducted qualitative
interviews with patients, clinicians and relevant stakeholders to inform the development of
the proposed mobile app intervention. For the randomized-controlled trial, the investigators
will recruit and randomly assign 180 adult patients prescribed oral chemotherapy to receive
either the intervention (completed smartphone mobile app) or standard care.

Objective/Hypothesis: The goals of this study are to assess the feasibility and efficacy of a
mobile application to help improve adherence to oral chemotherapy and symptom to patients
with cancer. We will administer the intervention at three cancer centers, hypothesizing that
patients with who use the mobile app will report better adherence to their oral chemotherapy
and better management of symptoms than those patients who were not assigned to the
intervention.

Specific Aims: The primary aims of this study are 1) to implement a patient-centered mobile
application to assess symptoms, side effects, and adherence to oral chemotherapy that is
feasible for use in oncology patients, and 2) to evaluate the efficacy of the mobile
application in improving patient-reported clinical outcomes.

Study Design: We will recruit and randomly assign 180 patients from the three cancer care
sites who have recently been prescribed oral chemotherapy to receive either the mobile app
intervention or standard care. Participants will be stratified by study site (i.e.
Massachusetts General Hospital (MGH), North Shore, MGH West, and Emerson Cancer Centers),
cancer type, and line of chemotherapy. This will ensure relatively equal percentages of
patients from each study site, diagnosis, and line of chemotherapy will be represented in the
treatment and control groups. The mobile app intervention which will consist of completing an
initial chemotherapy treatment plan with their oncology clinicians, responding to weekly
assessments regarding symptoms, side effects, and medication adherence, as well as receiving
personalized feedback about responses each week for 12 weeks. Medication adherence, symptom
severity, and quality of life will serve as primary outcomes, and we will collect measures of
quality cancer care as secondary targets. We will also explore whether particular patient
characteristics (i.e. cancer type, demographics) affect patient response to the mobile app
intervention.

Inclusion Criteria:

Patient Participant Inclusion Criteria

- Age greater than 18 years

- Diagnosis of cancer with a new or existing prescription for oral chemotherapy

- Receiving cancer care at either Massachusetts General Hospital Cancer Center or
community affiliates (North Shore or Emerson Hospitals)

- Eastern Cooperative Oncology Group (ECOG) ranging from 0 (asymptomatic) to 2
(symptomatic and in bed >50% of the day)

- Able to read and respond to questions in English

- Uses smart mobile phone (either operating system (iOS) [iPhone] or Android device)

Clinician Participant Inclusion Criteria - Clinician participants must be oncology
clinicians (i.e. physicians and nurse practitioners) who maintain at least 25% clinical
practice at the Massachusetts General Hospital Cancer Center or one of its community
affiliates at the North Shore or Emerson Hospital.

Stakeholder Participant Inclusion Criteria - Four groups of stakeholders will provide
ongoing feedback about the study design, methods, and results. To be eligible as a
stakeholder, the participant must be able to represent the interests and perspective of at
least one of the following stakeholder groups:

- Oncology Patient or Family Member

- Oncology Clinician (e.g., Physician or Nurse Practitioner)

- Cancer Practice Setting Administrator Health System, Community, and Society.

Exclusion Criteria:

Patient Participant Exclusion Criteria

- Individuals with co-morbid acute or untreated psychiatric symptoms (e.g., psychosis)
or neurologic dysfunction will be excluded given that such symptoms would interfere
with consent and participation.

- Individuals who own Windows or Blackberry smart mobile phones will not be eligible.