N/A Completed N=181 Randomized Single-blind Supportive Care

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

Adherence to Medication Regime · Cancer

Source: ClinicalTrials.gov NCT02157519 ↗

Enrolled (actual)

181

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcomePrimary: Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week — 11; 20 Participants — p=0.186

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week	11; 20	0.186
PRIMARY Adherence to Oral Chemotherapy Medication	81.50; 79.16	0.57
PRIMARY Change in Symptoms and Side Effects	-0.03; 0.08; -0.12; -0.11	0.603
PRIMARY Change in Quality of Life	0.49; -1.93; 0.81; 0.11; -0.55; -2.22	0.144
SECONDARY Treatment Satisfaction	0.04; -0.34; 0.07; -0.29; 0.08; -0.89	0.170
SECONDARY Emergency Department Visits	0.16; 0.14	0.682
SECONDARY Hospitalizations	0.20; 0.15	0.640

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02157519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.