Clinical trial NCT02157519: Mobile Application for Improving Symptoms and Adherence to Oral Chemotherapy in Patients With Cancer
Official title: Mobile Application for Improving Symptoms and Adherence to Oral Chemotherapy in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence to Medication Regime
Cancer
Keywords: Oral Chemotherapy
Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Many people treated for cancer receive oral chemotherapy medications for their illness. This means that much of their cancer care occurs at home, away from a traditional oncology care setting. The purpose of this study is to explore how a Smartphone mobile application ("mobile app") can help improve the cancer treatment process in people who are prescribed oral chemotherapy medication. The investigators will explore how well the mobile app helps patients stay connected with their oncology care team, take their oral medications as prescribed, and manage their cancer-related symptoms from home. This study will be done in two phases: 1) a pilot phase to assess the feasibility of a mobile application intervention, and 2) a randomized-controlled trial to test the intervention.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week
timeFrame: Post-Assessment (12-14 weeks after baseline) controlling for baseline assessment
measure: Adherence to Oral Chemotherapy Medication
timeFrame: Daily over course of study from baseline (within 2 weeks after enrollment) to post assessment (12-14 weeks after baseline)
measure: Change in Symptoms and Side Effects
timeFrame: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
measure: Change in Quality of Life
timeFrame: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Secondary outcomes:
measure: Treatment Satisfaction
timeFrame: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
measure: Emergency Department Visits
timeFrame: Post-Assessment (12-14 weeks after baseline)
measure: Hospitalizations
timeFrame: Post-Assessment (12-14 weeks after baseline)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital/North Shore Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Concord
country: United States
facility: Massachusetts General Hospital At Emerson Hospital-Bethke
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph Greer, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fishbein JN, Nisotel LE, MacDonald JJ, Amoyal Pensak N, Jacobs JM, Flanagan C, Jethwani K, Greer JA. Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development. JMIR Res Protoc. 2017 Apr 20;6(4):e62. doi: 10.2196/resprot.6198.