18 and older, any sex, with Adherence to Medication Regime or Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past WeekPrimary· Post-Assessment (12-14 weeks after baseline) controlling for baseline assessment
The Morisky Medication Adherence Questionnaire (MMAS-4) - a 4-item questionnaire that assesses medication adherence in the past week by asking patients to indicate "yes" or "no" to each item (self-report). The four items ask patients to self-report whether they forgot to take their oral chemotherapy (OC) medication in the past week, whether they had any problems remembering to take their OC medication in the last week, whether they stopped taking their OC medication when they felt better in the past week, and whether they stopped taking their OC medication when they felt worse in the past week
Group
Value
95% CI
Mobile Application Intervention
11
Standard Oncology Care
20
Adherence to Oral Chemotherapy MedicationPrimary· Daily over course of study from baseline (within 2 weeks after enrollment) to post assessment (12-14 weeks after baseline)
Medication Event Monitoring System (MEMS) utilizes an electronic pill cap to record the date and time the pill dispenser was opened.
Group
Value
95% CI
Mobile Application Intervention
81.50
± 2.93
Standard Oncology Care
79.16
± 2.78
Change in Symptoms and Side EffectsPrimary· Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
M.D. Anderson Symptom Inventory (MDASI): a 19-item instrument that assesses the most common symptoms and side effects related to cancer and its treatment (self-report). The MDASI uses a 0-10 numerical rating scale for all items to assess the severity and interference of symptoms patients have experienced in the past 24 hours, with 0 being "not present" or "did not interfere" and 10 being "as bad as you can imagine" or "interfered completely". The ratings in the MDASI are averaged into two subscale scores: mean symptom severity (13 symptom items) and mean interference (6 interference items only
Change in Symptom Severity
Group
Value
95% CI
Mobile Application Intervention
-0.03
± 0.15
Standard Oncology Care
0.08
± 0.15
Change in Symptom Interference
Group
Value
95% CI
Mobile Application Intervention
-0.12
± 0.23
Standard Oncology Care
-0.11
± 0.23
Change in Quality of LifePrimary· Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Functional Assessment of Cancer Treatment - General (FACT-G): a 27-item questionnaire that assesses physical, social, emotional, and functional well-being (self-report). The FACT-G utilizes a five-point scale from 0 (not at all) to 4 (very much). Four subscales are computed by taking the sum: physical well-being (7 items; range 0-28), social/family well-being (7 items; range 0-28), emotional well-being (7 items; range 0-24), and functional well-being (7 items; range 0-28). The overall score is the sum of the four subscale scores (range 0-108). Higher scores indicate greater quality of life, wh
FACT-General
Group
Value
95% CI
Mobile Application Intervention
0.49
± 1.19
Standard Oncology Care
-1.93
± 1.13
FACT-Physical Well-Being
Group
Value
95% CI
Mobile Application Intervention
0.81
± 0.48
Standard Oncology Care
0.11
± 0.45
FACT-Social Well-Being
Group
Value
95% CI
Mobile Application Intervention
-0.55
± 0.53
Standard Oncology Care
-2.22
± 0.50
FACT-Emotional Well-Being
Group
Value
95% CI
Mobile Application Intervention
0.04
± 0.41
Standard Oncology Care
0.53
± 0.40
FACT-Functional Well-Being
Group
Value
95% CI
Mobile Application Intervention
0.35
± 0.43
Standard Oncology Care
-0.40
± 0.41
Treatment SatisfactionSecondary· Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Description: Functional Assessment of Chronic Illness Treatment-Treatment Satisfaction-Patient Satisfaction (FACIT-TS-PS), 21-items that assesses patient satisfaction with doctor and staff competence, communication, and confidence and trust in providers, as well as overall satisfaction of care (self-report). The FACIT-TS-PS uses a 0-3 numerical rating scale to assess satisfaction with healthcare, with 0 representing the lowest level of satisfaction and 3 representing the highest level of satisfaction. Four subscales are computed by taking the sum: explanations (4 items; range 0-12), interperso
FACIT-Clinician Explanations
Group
Value
95% CI
Mobile Application Intervention
0.04
± 0.20
Standard Oncology Care
-0.34
± 0.19
FACIT-Interpersonal Treatment
Group
Value
95% CI
Mobile Application Intervention
0.07
± 0.13
Standard Oncology Care
-0.29
± 0.13
FACIT-Comprehensive Care
Group
Value
95% CI
Mobile Application Intervention
0.08
± 0.52
Standard Oncology Care
-0.89
± 0.49
FACIT-Nursing Care
Group
Value
95% CI
Mobile Application Intervention
-0.45
± 0.20
Standard Oncology Care
-0.26
± 0.19
FACIT-Trust in Clinicians
Group
Value
95% CI
Mobile Application Intervention
-0.24
± 0.13
Standard Oncology Care
-0.24
± 0.12
Emergency Department VisitsSecondary· Post-Assessment (12-14 weeks after baseline)
Resource Utilization Questionnaire, an adapted 3-item questionnaire inquiring about the number of emergency department visits and hospitalizations over the past three months (self-report). Patients are asked to indicate how many times they have gone to the emergency room in the past three months on a numerical scale ranging from 0 to "5 or more". Scores ranged from 0-5. A higher score represents more frequent emergency department visits, indicating higher resource utilization.
Group
Value
95% CI
Mobile Application Intervention
0.16
± 0.04
Standard Oncology Care
0.14
± 0.04
HospitalizationsSecondary· Post-Assessment (12-14 weeks after baseline)
Description: Resource Utilization Questionnaire, an adapted 3-item questionnaire inquiring about the number of emergency department visits and hospitalizations over the past three months (self-report). Patients are asked to indicate how many times they have been admitted to the hospital in the past three months on a numerical scale ranging from 0 to "5 or more". Scores ranged from 0-5. A higher score represents more frequent hospital admissions, indicating higher resource utilization.
Group
Value
95% CI
Mobile Application Intervention
0.20
± 0.07
Standard Oncology Care
0.15
± 0.07
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected during the active study period (study enrollment through post-assessment completion). As this was a behavioral intervention, adverse events were not assessed at any pre-specified time. Rather, they were recorded as reported by participants at any point during their study participation..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Mobile Application Intervention
Serious: 0/91 (0%)
Deaths: 3/91
Standard Oncology Care
Serious: 0/90 (0%)
Deaths: 1/90
Other adverse events (1 terms — click to expand)
Reaction
System
Mobile Application Interve…
Standard Oncology Care
Adherence data of one study participant was lost in the mail
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04626830 — Mobile Application to Assist Adherence to Oral Anticancer Agents and Symptom Management
· NA
· completed
NCT02996435 — Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation
· Phase 4
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 19 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02157519.